Staying informed on the latest pharmaceutical compliance updates is essential for navigating an increasingly complex global regulatory landscape. From evolving GMP requirements and regulatory guidance to enforcement actions and emerging risks, these updates directly impact how organizations manage quality, ensure compliance, and protect patient safety. This summary highlights key developments across major health authorities and industry bodies, providing insights to help life sciences organizations stay aligned, proactive, and prepared.
Written by Laurel Hacche, Jim Qi, and Debra Cortner
Agência Nacional de Vigilância Sanitária (ANVISA)
A clandestine food supplement factory in the city of Itapemirim (ES) was closed on 19 August 2025 by ANVISA and local Health Surveillance. Irregular production was identified during an inspection of the Food Supplement Industries Inspection Program, conducted by ANVISA in conjunction with Health Surveillance of states and municipalities. During the inspection at the Verdeflora company, a clandestine shed was found near the site, where products without regularization were manufactured. In the shed, food supplements and phytotherapeutic medicines without registration with ANVISA were identified in precarious hygienic-sanitary conditions. Given the seriousness of the situation, the team requested police support, since the scenario could characterize flagrant crime against public health, subject to arrest. However, those responsible for the company were not located by the police. The clandestine establishment was banned and sealed. The inspection report will be forwarded to subsidize the complaint to the Public Prosecutor’s Office and initiate a sanitary administrative procedure against those responsible. The products found in the shed will be collected and made useless, as determined by the local health code.
Determined Precautionary Prohibition of Pneumonia Medication and Anesthetic, 06 October 2025
An ANVISA inspection action on 06 October 2025 determined precautionary prohibition of Vancotrat 500 mg, a medicine indicated for the treatment of infections of the lower respiratory tract (such as pneumonia). The antibiotic is produced União Química Farmacêutica Nacional S/A. The measure only applies to Batch 2518163 of the product, which is valid until April 2027. The reason for the action is the suspicion of a quality deviation for the cited batch. A change in the color of the medicine was observed after its dilution; the solution showed an orange hue, which is different from what is described in its package insert.
Another drug affected by an AVISA action was Lidocaine Hydrochloride – 20 mg/ml, an anesthetic produced by Hypofarma – Institute of Hypodermia and Pharmacy Ltda. As published in the Official Gazette, only Batch 25010360, with an expiration date of 30 January 2027, is included in the precautionary ban. The precautionary ban occurred after an unidentified insect was found in a bottle of the medicine, in the aforementioned batch. The precautionary ban is a preventive and temporary measure that aims to protect the health of the population and remains in force while tests, analysis, or other measures required for the investigation and conclusion of the case are carried out. Therefore, the product should not be consumed or marketed until its safety is proven.
ANVISA Informs About Ban on Entry of Slimming Pens in Brazil, 20 November 2025
ANVISA has published resolutions prohibiting the manufacture, distribution, import, marketing, advertising and use of some GLP-1 agonist drugs, popularly known as “slimming pens”. They are medicines without sanitary registration with ANVISA; that is, they do not have quality, efficacy, and safety of use evaluated in Brazil. The measures were motivated by the increase in evidence of irregular advertising and commercialization of the so-called slimming pens, including on the internet, which is prohibited for medicines in Brazil. Thus, the resolutions were published to protect the health of the population. Medicines without registration in Brazil can only be imported exceptionally and for exclusively personal use, upon medical prescription and compliance with additional requirements. However, in cases where ANVISA publishes a specific ban, the import, by any modality, is also suspended.
ANIVSA Suspends Intravenous Catheter Batch due to Irregularity, 26 December 2025
ANVISA suspended Batch 22300/095 of the product Injex-Cath® SAFETY Invenous Catheter with Safety Device, manufactured by the company INJEX Indústrias Cirúrgicas Ltda (CNPJ: 59.309.302/0001-99). The measure includes the collection and prohibition of marketing, distribution, advertising, and use of the medical device. The decision was made after an evaluation of the device carried out by the Ezequiel Dias Foundation (FUNED), under the State Program for Monitoring the Quality of Medicines and Congeners (PROGMEC), which pointed out an unsatisfactory result in the test to verify the surface finish and visual appearance of the needle. The batch had a defect in the outer surface of the needle tube, in disagreement with the ABNT NBR ISO 9626:2020 standard.
China: National Medical Products Administration (NMPA)
With the rapid development of e-commerce, the online medical device sales market in China has experienced explosive growth in recent years. According to statistics, from 2018 to the present, the number of medical device distributors engaged in online sales has increased from 8,717 to over 360,000, while the number of third-party platform enterprises has grown from 77 to 851. The NMPA has always attached great importance to the quality and safety of medical device online sales, continuously improving the relevant regulations for online sales of medical devices. The relevant provisions on online sales have been incorporated into the newly revised Regulations for the Supervision and Administration of Medical Devices, and the Measures on the Supervision and Administration of Online Sales of Medical Devices have been issued and implemented to promote the healthy and orderly development of the online medical device market.
As an important normative document to guide the quality management as well as supervision and administration of online sales of medical devices, the Quality Management Specifications for Online Sales of Medical Devices focus on four key principles:
- Upholding and implementing the requirements of laws and regulations.
- Ensuring the fulfillment of the primary responsibilities by enterprises.
- Summarizing and building on regulatory practice and experience.
- Extensively listening to and responding to industry demands.
China Issues Revised Medical Device Good Manufacturing Practice, 11 November 2025
The NMPA issued the newly revised Medical Device Good Manufacturing Practice (2025 Medical Device GMP) on 04 November 2025. This is the first full revision of the Medical Device GMP since the second revision in 2014. The 2025 Medical Device GMP revises the main part of the Device GMP and does not affect the appendices, which cover specialized areas, such as dental devices, sterile devices, implantable devices, and software as a medical device. The 2025 Medical Device GMP takes effect on 01 November 2026, giving medical device companies a grace period of one year to review and update their internal system for compliance with the new requirements.
The 2025 Medical Device GMP is a substantial revision. Among the most significant structural changes, the regulation now specifically addresses the different roles of medical device registrants (for Class II and III devices), filers (for Class I devices), and the entrusted manufacturing companies (contract manufacturers) engaged by Registrants and Filers (R/Fs). It contains provisions that apply to research and development, production, processing (i.e., entrustment of specific processes), and product testing entrusted to third parties, and requires integration of these functions and entrusted-parties into a unified quality management system that a given device-R/F must oversee as the party chiefly responsible for product quality throughout the device’s lifecycle.
On 17 November 2025, the NMPA issued the Opinions on Deepening the Reform of Cosmetics Regulation and Promoting High-Quality Industry Development (Opinions on Cosmetics). The Opinions on Cosmetics propose 24 reform measures across five key areas, aiming to further strengthen the cosmetic industry’s quality and safety baseline, foster new productive forces, and promote high-quality industry development. These measures focus on encouraging innovation, optimizing registration and filing management, strengthening risk prevention and control throughout the entire supply chain, enhancing intelligent regulation, and aligning regulatory practices with international standards.
The Opinions on Cosmetics state that by 2030, the legal and regulatory framework for cosmetics regulation will be more complete, the standards system more sound, technical support more robust, industrial innovation vitality stronger, risk prevention and control capabilities comprehensively enhanced, and the level of quality and safety significantly improved. By 2035, the cosmetics quality and safety regulatory system will reach an internationally advanced level, the industry’s capacity for innovation and global competitiveness will be significantly enhanced, and regulatory modernization will be essentially achieved.
European Medicines Agency (EMA)
Nitrosamine Impurities in Human Medicines, 08 July 2025
A report was published outlining the European medicines regulatory network’s response to nitrosamine impurities in human medicines. The report summarizes the scientific and regulatory milestones since the discovery of nitrosamine impurities in 2018. Theses impurities were detected in a group of cardiovascular medicines known as sartans and later also in other medicines. The report:
- Highlights key scientific reviews, including Article 31 reviews of sartans and ranitidine and Article 5(3) review for all human medicines under Regulation (EC) No 726/2004.
- Describes the regulatory framework that manages nitrosamine impurities.
- Presents advances in scientific knowledge on quality and safety of nitrosamines.
- Details the harmonized approach implemented in the European Union to protect patients and ensure medicine availability.
- Describes the European medicines regulatory network’s collaboration with international partners, industry, healthcare professionals and patients to ensure the continued safety and availability of medicines.
Eudralex, Volume 4: GMP Guidelines and Annexes
On 07 July 2025, the European Commission (EC) released the following draft revisions of Eudralex Volume 4 for public consultation with a deadline of 07 October 2025 for submission of comments:
- Revised Chapter 4: Documentation
- Revised Annex 11: Computerized Systems
- New Annex 22: Artificial Intelligence
The revised Chapter 4: Documentation incorporates changes that highlight the importance of documentation in GMP compliance and supports the use of new technologies, hybrid solutions, and new services in the management of documentation. Risk-management principles are now central and integrated within the data governance system to ensure the accuracy, integrity, availability, and legibility of documents across all formats: paper, digital, or hybrid. All documentation, whether in text, image, video, or audio form, must remain complete and readable throughout its lifecycle. The revised Chapter 4 also clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.
The revised Annex 11: Computerized Systems establishes enhanced requirements for the lifecycle management of computerized systems, mandating that Quality Risk Management principles be comprehensively applied during all steps. The updated provisions reinforce obligations concerning the definition and ongoing maintenance of system requirements and the oversight of suppliers and external service providers. Furthermore, the revised Annex 11 strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.
The new Annex 22: Artificial Intelligence (AI) establishes requirements for the use of AI and machine learning in the manufacturing of active substances and medicinal products. It sets up requirements for the selection, training, and validation of AI models. Emphasis is placed on the definition of the intended use of the model, the establishment of performance metrics, the quality of model training data, and the management and processing of test data. Annex 22 foresees a continuous oversight of AI systems, including change control, model performance monitoring, and procedures for human review when necessary.
On 03 September 2025, the European Commission (EC) released a draft revision of Eudralex Volume 4, Chapter 1 for public consultation with a deadline of 03 December 2025 for submission of comments. The revised Chapter 1 reflects the updated ICH guideline on Quality Risk Management, ICH Q9(R1), strengthening knowledge management and risk management across the product lifecycle. Alignment with ICH Q9(R1) fosters a proactive, evidence-based culture that reduces variability in quality outcomes. By embedding risk-based decision-making and emphasizing scientific rationale and proportionality in risk assessment, it ensures consistent product quality and availability. The revision also stresses the importance of proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities, thereby safeguarding patient safety and public health. The guideline also clarifies requirements for product quality review, particularly regarding product grouping and situations where only a limited number of batches were manufactured during the review period.
Eudralex, Volume 10: Clinical Trial Guidelines
New and Updated Clinical Trial Guidelines Published in Eudralex Volume 10, 27 November 2025
The European Commission has published new and updated guidance documents in Volume 10 of The Rules Governing Medicinal Products in the European Union (EU) which applies to clinical trials under the Clinical Trials Regulation (EU) No 536/2014. These updates, published on 30 October 2025, provide essential information and are relevant for sponsors and stakeholders involved in clinical trials within the EU. The updated guidance aims to:
- Streamline clinical trial processes
- Enhance harmonization across EU Member States
- Support innovative trial designs, including decentralized approaches
The new and updated documents are:
- Recommendations on Criteria Regarding the Selection of a Reporting Member State
- Recommendation Paper on Decentralized Elements in Clinical Trials
- Recommendation Paper on Frequent Issues for Part I and Part II in Clinical Trials
- Auxiliary Medicinal Products in Clinical Trials
Health Canada
Health Canada is warning the public of seized unauthorized injectable peptide drugs from Canada Peptide. The products were being sold via the company’s website. Peptide drugs affect the body’s functions and are often used for bodybuilding, anti-aging, or enhancing athletic performance. Injectable peptides are regulated as prescription drugs in Canada. Health Canada has not authorized any of the products that were seized or sold on the company’s website, which means that they have not been assessed for safety, efficacy, and quality. Selling unauthorized drugs is illegal in Canada. Prescription drugs should only be used under the care of a healthcare professional because they are used to treat specific conditions and may cause serious side effects. Unauthorized injectable drugs may:
- Cause infection, allergic reactions, and other poor outcomes.
- Interact with other medications an individual might be taking.
- Contain high-risk ingredients, additives, or contaminants that may or may not be listed on the label.
- Not have been manufactured or stored safely.
Health Canada is proposing a second phase of regulatory amendments to the Medical Devices Regulations (MDR). The first phase of amendments was published in Canada Gazette, Part II on 17 June 2024 and came into force on 14 December 2024. The proposed second phase of amendments for medical devices would:
- Remove the requirement for foreign distributors to hold a Medical Device Establishment License (MDEL) if they are selling their medical devices through Canadian importers already holding an MDEL.
- Clarify the requirement that MDEL holders must establish, implement, and maintain documented procedures.
- Require all MDEL applicants and license holders to provide a list of suppliers for the medical devices they import or sell in Canada.
The proposed amendments would deliver on the regulatory modernization commitments in the Health and Biosciences Regulatory Review Roadmap. Health Canada has invited stakeholders to review the proposed amendments and participate in the consultation. Consultations opened on 08 November 2025 and closed on 17 January 2026.
Consultation: Modernizing the Framework for Clinical Trials, 20 December 2025
Health Canada is seeking feedback on the proposed Clinical Trials Regulations for drugs (pharmaceuticals, biologics, and radiopharmaceuticals) and on multiple guidance documents related to the proposal with a deadline for feedback of 20 March 2026. The proposed framework would replace the clinical trial regulatory schemes for drugs in the following sections of the regulations:
- Part C, Division 5 of the Food and Drug Regulations
- Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
This proposed framework aims to improve access to new and innovative therapies for people in Canada while maintaining strong safety protections for participants. This initiative is part of Health Canada and the Public Health Agency of Canada’s work to streamline processes and enhance regulatory efficiency. These are outlined in the Red Tape Reduction Report.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances – Quality, Efficacy, Multidisciplinary, and Safety
ICH Q3E, Draft Guideline for Extractables and Leachables, 06 August 2025
The ICH Q3E draft Guideline for Extractables and Leachables and supporting documents reached Step 2b of the ICH Process on 01 August 2025 and entered the Step 3 public consultation period. The draft guideline presents a framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7). The framework of this guideline follows the principles of risk management as described in ICH Q9. While the guideline includes materials characterization and process understanding, its primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product. The Q3E draft Guideline and supporting document is available for download on the Q3E EWG page.
International Pharmaceutical Excipients Council (IPEC)
IPEC Federation announces the release of its Best Practices Guide for European REACH Restriction on Synthetic Polymer Microparticles (SPM) for Pharmaceutical Excipients (Version 1, 2025). Originally issued in 2022 as a joint development document by IPEC Americas and IPEC Europe, the document is now issued by the IPEC Federation. The document offers a streamlined process to help polymer manufacturers, suppliers, and downstream industrial users (including drug product manufacturers) to meet the regulatory expectations associated with the European REACH Restriction of SPM. Readers are encouraged to consult this Guide together with the relevant regulation and guidance documents:
- The Regulation: Annex XVII of EC 1907/2006, Entry 78 (EU 2023/2055)
- The Guidance: REACH Restriction of Synthetic Polymer Microparticles (Entry 78 of Annex XVII REACH, introduced by Commission Regulation (EU) 2023/2055)
- The Reporting Requirements: Implementation of the Reporting Requirements of the REACH Restriction on Microplastics European Chemicals Agency (ECHA), April 2025 (v1.1)
International Organization for Standardization (ISO)
The Artificial Intelligence (AI) and Multimedia Standards Collaboration (AMAS), a global multistakeholder initiative led by the World Standards Cooperation, has launched two flagship papers to combat global disinformation, misinformation, and the misuse of AI generated content at the AI for Good Global Summit in Geneva. The first technical paper offers a comprehensive overview of the current landscape of standards and specifications related to digital media authenticity and AI. The second policy paper provides policymakers with guidance on how to leverage international standards for the effective regulation of the creation, use, and dissemination of synthetic multimedia content.
ISO 22002-1:2025, Prerequisite Programmes on Food Safety, Part 1: Food Manufacturing, July 2025
ISO 22002-1:2025, Prerequisite Programmes on Food Safety, Part 1: Food Manufacturing specifies, in conjunction with ISO 22002-100, requirements for establishing, implementing, and maintaining prerequisite Programmes (PRPs) to control food safety hazards in food manufacturing.
ISO 10993-1 is the cornerstone standard for biological evaluation of medical devices. It defines the principles and requirements for assessing a device’s biological safety within the broader risk management framework established by ISO 14971. The standard guides manufacturers and evaluators through the process of identifying, assessing, and managing biological risks associated with materials, design choices, and tissue contact during a device’s intended use. The sixth edition of ISO 10993-1 has been completely reorganized to align with ISO 14971. It adds new guidance on exposure duration, materials, characterization, and identification of biological hazards. Terminology has been updated for clarity, and new annexes explain the rationale behind these changes.
The Next ISO 9001 Revision, 05 December 2025
On 27 August 2025, the ISO Working Group (WG 29) released the Draft International Standard (DIS) of ISO 9001:2026. This version is circulated to ISO member bodies for a final review and ballot. While the DIS is not publicly available, its content is well-known to participating national bodies and experts. Based on the DIS content and controlled review and voting process, only minor refinements are expected from this stage onward. The final publication of ISO 9001:2026 is projected for September 2026. Following publication, certified organizations will have a three-year transition period (until approximately September 2029) to migrate to the next version of ISO 9001, a timeline subject to formal confirmation by the International Accreditation Forum (IAF). The DIS reveals a standard that evolves rather than revolutionizes. While the length of ISO 9001 increases, most additions are in the non-mandatory sections (front matter and Annex A) which provide implementation guidance. The core requirements (Clauses 4-10) feature only minor changes, meaning a minimal transition burden for organizations already compliant with ISO 9001:2015. Key confirmed changes in the DIS are:
- Integration of Climate Considerations
- Expansion of Leadership Responsibilities
- Tweaks to Quality Policy
- Clarified Risk and Opportunity Management
- Expansion of Awareness
International Society for Pharmaceutical Engineering (ISPE)
ISPE GAMP Guide: Artificial Intelligence, July 2025
The ISPE GAMP Guide: Artificial Intelligence (AI) is the single source for a holistic interpretation on effectively developing and using AI-enabled computerized systems in GxP areas, while safeguarding patient safety, product quality, and data integrity. It reviews existing guidance and expectations on good practices and presents additional concepts for areas not covered by guidance. Offering a robust, cost-effective approach when applied with expertise and good judgement, the framework presented in this guide helps to ensure that AI-enabled computerized systems are of high-quality, effective, fit for their intended use, and compliant with applicable regulations. Key principles and practices relevant to the design, development, operation, and use of AI are also discussed.
ISPE Guide: Sustainability, August 2025
This ISPE Sustainability Guide is a foundational document that presents key principles and concepts to reinforce sustainable practices in the pharmaceutical industry, based on global and local guides, including existing regulations. The main objectives of the guide are to provide an overview of key environmental sustainability definitions, to develop a cohesive industry approach that integrates sustainability into existing pharmaceutical development, operations, quality and supply chain processes, and to provide guidance on the management of sustainability programs, including the use of metrics to measure performance. Key concepts discussed include:
- Product and Environmental Sustainability
- Net-Zero (Greenhouse Gas Emissions)
- Nature Positive
- Sustainability by Design
- Circular Economy
- Ethical Considerations
Water and steam are used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations. Systems that generate and distribute water and steam that may come into contact with product or process contact surfaces, or used in product testing, are subject to Commissioning and Qualification (C&Q) (verification). Water can also be a final product, for example, as a pharmacopeial water and as part of a combination product. The third edition of the ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems incorporates the general changes in C&Q approaches developed and instituted over the past 10 years. It contains chapters on process analytical technology and rapid microbial methods, and appendices covering process water, pure steam, and process steam, typical specifications, change management, and a sample turnover package.
Advanced Therapy Medicinal Products (ATMPs) represent a revolutionary frontier in medicine, offering life-changing treatments for conditions previously deemed incurable. However, the intricate nature of these therapies, from their unique raw materials to complex manufacturing and logistics, presents significant challenges and inherent risks. The ISPE Guide: Advanced Therapy Medicinal Products – Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle offers practical guidance on applying validation methods and control throughout the cell and gene therapy product lifecycle. It outlines risk-based strategies tailored to the unique nature of these products, addressing key areas such as analytical methods, equipment, processes, cleaning, and supply chain. It also includes essential insights into regulatory expectations and phase-appropriate considerations that support timely development and commercialization.
Medicines and Healthcare Products Regulatory Agency (MHRA)
Decentralized Manufacturing: Emerging Considerations, 15 September 2025
The MHRA legislation for Decentralized Manufacturing (DM) is The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, Statutory Instrument (SI) 2025 No. 87, and it came into force in 23 July 2025. In the period between this SI being signed into law on 23 January 2025 and it coming into force, regulatory guidance documents were developed through an in-person workshop on 12 March 2025 and further comments received after the workshop. These documents, together with other DM information, have been published on the new Decentralized Manufacture Hub. This new framework is applicable to all dosage forms to enable faster access for patients to lifesaving, personalized treatments whilst maintaining current standards of product quality, safety and efficacy. This framework provides manufacturers with new alternatives in a broadened range of manufacturing and supply options beyond those in the current factory-based model, i.e., centralized manufacturing. The framework is not only for new products. It also provides an option for existing centrally manufactured products at clinical trial or authorized, which will benefit from DM, to change based on an appropriately supported and justified variation.
Officers from the Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) have dismantled a major illicit manufacturing facility, making and distributing unlicensed weight-loss jabs, during a raid on a warehouse in Northampton. This is the first illicit production facility for weight loss medicine discovered in the UK and is believed to be the largest single seizure of trafficked weight loss medicines ever recorded by a law enforcement agency worldwide. During the search, MHRA officers, supported by Northamptonshire Police, seized tens of thousands of empty weight loss pens ready to be filled, raw chemical ingredients, and more than 2,000 unlicensed retatrutide and tirzepatide pens awaiting dispatch to customers. The street value of the finished weight loss products alone is estimated to be more than a quarter of a million pounds.
On 25 November 2025, three individuals were convicted for their roles in an organized criminal group responsible for the large-scale unlawful supply of unauthorized medicinal products online, one individual was found not guilty. A fifth pleaded guilty at an earlier hearing. The investigation, led by the MHRA’s Criminal Enforcement Unit (CEU) and known as Operation Lamborghini, uncovered an organized criminal network operating a series of websites to illegally supply unlicensed medicines, including those controlled as Class B and Class C drugs. The investigation identified almost two million doses of medicinal controlled drugs and other medicines linked to the criminal group. These included benzodiazepines (such as Diazepam, Clonazepam, Lorazepam and Alprazolam), Zolpidem, Zopiclone, and the Class B drug Codeine, alongside unauthorized versions of medicines including Sildenafil. Prescription only medicines Zapain and Modafinil were also supplied unlawfully.
In Vitro Diagnostics Roadmap, 15 December 2025
The MHRA committed to publishing an In Vitro Diagnostics (IVD) Roadmap as part of the MedTech Regulatory Reform roadmap. There are commitments in the 10 Year Health Plan and the Life Sciences Sector Plan to expand diagnostics into community settings and speed up access to innovative diagnostics. The roadmap supports the development and access of innovative IVD devices which play a critical role in improving patient outcomes through timely diagnosis and effective treatment. The roadmap sets out broad timelines and deliverables across 2026 and 2027 across three themes:
- Regulatory support for innovative IVD technologies: providing guidance for new technologies and companion diagnostics.
- Regulatory science and research: promoting scientific research, standards, and reference materials for emerging diagnostics.
- Pandemic preparedness and resilience: strengthening regulatory frameworks and international collaboration for future health emergencies.
Parenteral Drug Association (PDA) – Technical Reports and Guidances
Points to Consider No. 13: Materials in ATMP Manufacturing, September 2025
Points to Consider No. 13: Materials in ATMP Manufacturing provides key points for navigating the complexities of raw materials in the manufacturing of Advanced Therapy Medicinal Products (ATMP), aiming to guide stakeholders in establishing robust strategies for raw material management, promoting best practices, and supporting the safe and effective development and manufacturing of ATMPs. The unique nature of ATMPs presents distinct challenges compared to traditional pharmaceuticals, demanding a focused approach to material selection, qualification, and supplier management. Specifically addressed in this document are the intricacies arising from the fact that ATMP raw materials are often animal- or human-derived, but not monographed, not manufactured for Good Manufacturing Practice (GMP) applications (e.g., research-only grade), and single-sourced or required to be used for aseptic manufacturing.
Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products replaces the previous revision of PDA Technical Report No. 22: Process Simulation Testing for Aseptically Filled Products published in 2011. The intent of the current effort is to update that document to reflect the changes in aseptic processing that have occurred within the global industry and the regulatory landscape and, specifically, to support a site’s holistic Contamination Control Strategy (CCS). The authors have attempted to address the subject as fully as possible, recognizing the notable contributions made by other organizations, regulators, compendia, and individuals who have worked in this area. In addition, the report provides guidance on and supports sound risk-based approaches in the design and execution of Aseptic Process Simulation (APS). Insights from the discussion between industry experts and regulatory agencies on the latest revision of the European Union (EU) GMP Annex 1: Manufacture of Sterile Medicinal Products (issued August 25, 2022) and concerning APS have been considered in this document to include the current thinking and guidance on this topic.
Manufacturing Technology Guide No. 1: Aseptic Filling, Engineering, and Operation, October 2025
The PDA Manufacturing Technology Guide No. 1: Aseptic Filling, Engineering, and Operation is designed to communicate the Parenteral Drug Association’s thoughts on the topic and encourage further dialog among industry, health authorities, and suppliers of technology and materials, taking into consideration the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. This guide provides an overview of the elements that should be considered in the selection of an appropriate filler technology and for the successful integration of the filling system into the broader aseptic operation. Precautions with regard to Sterility Assurance (SA) are paramount for both liquid and powder filling systems. Innovation in filling technology continues throughout the industry in an effort to improve filling precision, increase throughput, reduce the need for interventions, and improve SA. This document will serve as a comprehensive resource for the considerations and components to be included in any design project.
Technical Report No. 26 (Revised 2025): Sterilizing Filtration of Liquids, November 2025
Sterilizing filtration is the process of removing microorganisms from a fluid stream without adversely affecting product quality. This technical Report (TR) is intended to provide a systematic approach to selecting and validating the most appropriate filter for liquid sterilizing filtration applications. PDA’s original Technical Report No. 26: Sterilizing Filtration of Liquids, (TR-26) published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. A revision of the original report was developed in 2008 in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry at that time. The current revision has been implemented to reflect current best practices and regulatory expectations, as well as clarify the roles of filter suppliers and end-users.
Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
The PIC/S Concept Paper on Revision of the Guidelines on Good Manufacturing Practice for Medicinal Products – Annex 6: Manufacturing of Medicinal Gases address the need to update this annex. Annex 6 is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the participating authorities of the PIC/S. The last revision of Annex 6 was adopted by the European Commission (EC) in 2010, and an update is necessary to take into account changes in current practice and stakeholder recommendations made to the agency following the COVID-19 pandemic. The objective is to carry out a limited review and update of the guideline to reflect industry’s current practices and the use of new technologies and computerized systems in operations. The following areas are the focus of the revision:
- Requirements for premises
- Technological advances in production of medicinal gases
- Documentation of manufacturing activities
- Specificities of modern gas production
- Other relevant topics.
Public consultation on this concept paper starts on 11 February 2026 and ends on 11 April 2026.
Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) is increasing its efforts to make sure that software-based medical devices meet Australia’s regulatory requirements. This includes those using Artificial Intelligence (AI). TGA is already working closely with industry to:
- Encourage voluntary compliance
- Provide clear and consistent guidance
- Respond to complaints and reports of non-compliance
- Identify and address unlawful advertising and supply
The current focus includes review of AI digital scribes, which are introducing more advanced features such as diagnostic and treatment suggestions. These features may cause the software to become a medical device under the Therapeutic Goods Act 1989. Such devices must be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied or advertised, unless they are exempt or excluded.
The Therapeutic Goods Administration (TGA) has issued 10 infringement notices, totaling $198,000, to Midnight Health Pty Ltd (Midnight Health) for the alleged unlawful advertising of prescription-only weight-loss medicines in contravention of the Therapeutic Goods Act 1989 (the Act). Midnight Health operated telehealth platforms such as Youly, Stagger, and hub.health where it advertised prescription-only weight-loss medicines to the public between June 2024 and January 2025. The websites allegedly promoted the use and supply of Schedule 4 prescription-only medicines, including tirzepatide and semaglutide. The advertisements also made unapproved references to the treatment of serious diseases or conditions, such as anxiety and stroke, which are considered prohibited and restricted representations under the Act. Prohibited and restricted representations are not permitted in advertising for therapeutic goods without prior approval or permission from the TGA.
The TGA has accepted a court enforceable undertaking from Midnight Health, who acknowledges that the websites likely contravened relevant advertising rules. The undertaking is enforceable for a period of one year and requires Midnight Health to:
- Ensure it does not advertise therapeutic goods, including referring to individual prescription-only medicines in a way that breaches the Act
- Engage a compliance and legal consultant to advise on relevant therapeutic goods regulatory procedures
- Report actions taken to comply with the enforceable undertaking to the TGA
Breaching any term of the undertaking may result in the Federal Court imposing further orders on the company, including financial penalties or compensation.
The Therapeutic Goods Administration (TGA) has updated its Advertising Therapeutic Goods on Social Media Guidance to help advertisers to understand their responsibilities when promoting therapeutic goods via these platforms. While social media offers powerful opportunities for consumer engagement, any content that promotes the use or supply of therapeutic goods is considered advertising and must comply with regulatory requirements under the Therapeutic Goods Act 1989 (the Act). The TGA is addressing the increase in unlawful advertising on social media, in which businesses, health services and social media influencers are promoting prescription-only medicines such as Ozempic and cosmetic injectables, including Botox. These posts often use images, nicknames, hashtags, and influencer-style endorsements to promote the goods. The updated guidance incorporates feedback and frequently asked questions from a broad range of stakeholders. It explains:
- Types of social media activities that may be considered advertising
- Legal responsibilities of advertisers, including influencers and account holders
- Common compliance issues and how to avoid them, such as ensuring correct use of mandatory health warnings
- How to use testimonials and endorsements compliantly
Businesses and social media account holders, including influencers, are responsible for any content they create, share or manage. They must understand their legal obligations under the Act before advertising therapeutic goods.
United States Food and Drug Administration (FDA) – Regulations and Guidance
The FDA has issued a draft guidance to provide guidance to industry and FDA staff about the expectations for the Quality Management System Regulation (QMSR) requirements for premarket submissions once the final rule amending 21 CFR part 820 goes into effect on 02 February 2026. The medical device Current Good Manufacturing Practice (CGMP) requirements of the QMSR have been updated to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device Quality Management Systems (QMS): ISO 13485:2016). When final, this guidance is intended to assist medical device manufacturers in preparing and maintaining the QMS and other information required in premarket submissions stemming from the QMSR.
Questions and Answers Regarding Mandatory Recalls: Draft Guidance for Industry, December 2025
The purpose of Questions and Answers Regarding Mandatory Recalls: Draft Guidance for Industry document is to provide guidance to industry on the implementation of the mandatory cosmetics recall provisions of section 611 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act). The guidance in this document is in the form of Questions and Answers and provides answers to common questions that might arise about these mandatory recall provisions and FDA’s current thinking regarding their implementation. The draft guidance addresses a number of topics including:
- Types of cosmetics subject to FDA’s mandatory recall authority
- Determination of FDA to invoke its mandatory recall authority
- Process for a mandatory recall
- Role of the responsible person
- Adulterated cosmetics
- Misbranded cosmetics
United States Food and Drug Administration (FDA) – Recalls and Corrective Actions
DermaRite Industries, LLC is voluntarily recalling individual lots of products (listed below) due to microbial contamination identified as Burkholderia cepecia. Burkholderia Cepacia Complex in these products may result in serious and life-threatening infections. The contaminated products may be used by immunosuppressed individuals or by people attending to immunosuppressed individuals. In healthy individuals with minor skin lesions the use of the product will more likely result in local infections, whereas in immunocompromised individuals the infection is more likely to spread into blood stream leading to life-threatening sepsis. To date, DermaRite has not received any reports of adverse events related to this recall.
- DermaKleen: An Over the Counter (OTC) Healthcare antiseptic lotion soap with Vitamin E indicated for handwashing to decrease bacteria on the skin.
- DermaSarra: An OTC External analgesic indicated for temporary relief of itching associated with minor skin irritations due to: dry skin, insect bites, detergents, sunburn.
- KleenFoam: An OTC Antimicrobial foam soap with Aloe Vera indicated for handwashing to decrease bacteria on the skin after changing diapers, after assisting ill people, or before contact with a person under medical care or treatment.
- PeriGiene: An OTC Antiseptic cleanser indicated for use in the perineal area.
Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation, or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree. This corrective action supersedes the previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death. Since the Field Corrective Action in 2023, Olympus conducted additional assessment on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the United States.
Customers were notified of the instructions for use updates through a September 2025 letter and were asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes. Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations.
StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dysfunction and belong to a class of drugs known as Phosphodiesterase Type‑5 (PDE‑5) inhibitors. Products containing sildenafil or tadalafil cannot be marketed as dietary supplements. MR.7 SUPER 700000 capsules are considered an unapproved new drug for which safety and efficacy have not been established and are therefore subject to recall.
Consumption of products containing undeclared sildenafil or tadalafil may cause serious health risks. These ingredients may interact with nitrates found in certain prescription medications (such as nitroglycerin) and may result in a dangerous drop in blood pressure, which can be life‑threatening. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease frequently take nitrates. Adult males who use nitrates for cardiac conditions are at the greatest risk. The tainted MR.7 SUPER 700000 capsules are marketed as a dietary supplement for male enhancement. The affected product does not have lot numbers or expiration dates. The product was distributed nationwide in the United States to a limited number of online customers between August 2025 and November 2025.
United States Food and Drug Administration (FDA) – Warning Letters
Amneal Pharmaceuticals, LLC Warning Letter, 27 August 2025
Amneal Pharmaceuticals, LLC, a manufacturer of finished pharmaceuticals, received a Warming Letter on 27 August 2025. This Warning Letter was a result of an FDA inspection that was conducted from 10 to 19 March 2025 at the Amneal Pharmaceuticals, LLC, Gujarat, India facility. The 483 observations sited included the following concerns:
- In 2024, the company initiated an investigation when two batches of ropivacaine hydrochloride injection, supplied in polypropylene bags, exceeded the acceptance criteria for visual inspection. Polypropylene bags were identified as the source of the inordinately high levels of particulate contamination (predominately, white fibers). An additional visual inspection was performed, and a risk assessment was conducted to justify release of the affected batches. However, the risk assessment was inadequate as it minimized the severity associated with particle contamination in a sterile injectable drug product that can be administered into the epidural space. The risk assessment failed to properly evaluate the potential impact of visible particulates on patient safety, as it did not adequately consider the route of administration and the patient population receiving the product.
- During the inspection, the FDA observed the preparation and reading of bacterial endotoxin tests and identified numerous deficiencies related to use of micropipettes, transfer of gel-clot sample tubes, verification of gel-clot assessment, and inadequate documentation practices.
Healthon Inc. dba Healthon, Warning Letter, 09 September 2025
Healthon Inc. dba Healthon received a Warning Letter on 09 September 2025 after the FDA reviewed the company’s website in August 2025 and observed that the website offers various compounded drug products, including semaglutide and tirzepatide. It was determined by the FDA that the company’s claims concerning compounded semaglutide and tirzepatide are false or misleading. The following claims concerning compounded semaglutide and tirzepatide products were on the company’s website:
- Same active ingredient as Wegovy and Ozempic
- Same active ingredient as Mounjaro pens and Zepbound
- Clinically proven weight loss
- The active ingredient in our formula is FDA approved
The Warning Letter states that compounded drug products are not FDA approved and the company’s claims imply that their drug products are the same as an FDA approved product when they are not. The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put the company on notice of the FDA’s concerns but do not represent an exhaustive list of misbranding violations. The Warning Letter also states that the company should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
King Farm, Waring Letter, 04 December 2024
King Farm, a non-FDA licensed feed mill that manufactures non-medicated animal food, received a Warning Letter on 04 December 2025. This Warning Letter was a result of an FDA inspection that was conducted from 16 to 19 June 2025. This inspection was initiated after FDA became aware of at least 30 horse deaths and potentially one goat death after consuming King Farm animal food products that were contaminated with the mycotoxin fumonisin. The company stated that it had recalled all potentially contaminated horse food products on approximately 01 May 2025.
During the inspection, FDA collected samples of the recalled King’s All Stock Feed, King’s Horse Feed 12-6 Blend, Byler Mix, and an unlabeled customer-formula all stock feed. Analysis performed by FDA found the products contained excessive levels of fumonisin, with total fumonisin levels ranging from 18 parts per million (ppm) to 36.1 ppm. These fumonisin levels are above FDA’s recommended limit for equids, which is 5 ppm for corn products not to be included at more than 20% of the diet (i.e., 1 ppm in complete animal food for equids). FDA considers the products sampled to be adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.
During the inspection, FDA also documented evidence of violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements located in Title 21, Code of Federal Regulations, Part 507 (21 CFR Part 507), which caused the company’s products to be adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
World Health Organization (WHO)
WHO, ITU, WIPO Showcase a New Report on AI use in Traditional Medicine, 11 July 2025
Artificial intelligence (AI) is ushering in a transformative era for traditional medicine, one where centuries-old healing systems are enhanced by cutting-edge technologies to deliver more safe, personalized, effective, and accessible care. At the AI for Good Global Summit, the World Health Organization (WHO), the International Telecommunication Union (ITU), and the World Intellectual Property Organization (WIPO) released a new technical brief, Mapping the application of artificial intelligence in traditional medicine. Launched under the Global Initiative on AI for Health, this brief offers a roadmap harnessing this potential responsibly while safeguarding cultural heritage and data sovereignty. The new brief showcases experiences in many countries using AI to unlock new frontiers in personalized care, drug discovery, and biodiversity conservation. It includes examples such as how AI-powered diagnostics are being used in Ayurgenomics; machine learning models identifying medicinal plants in countries including Ghana and South Africa; and the use of AI to analyze traditional medicine compounds to treat blood disorders in the Republic of Korea.
Animal testing has long been an important step in the development of medicinal biological products, providing critical information on their mechanisms of action, safety and efficacy. In some cases, such testing also continues to be used post-approval to monitor product quality or safety as part of the quality control processes of manufacturers and National Control Laboratories (NCLs). However, growing recognition that animal tests are generally inferior to appropriately developed in vitro assays for the routine Quality Control of biological products is becoming a key driver of a shift towards Quality Control schemes that avoid the use of animals altogether. As a result, major advances are now being made in the development and implementation of non-animal methods for the Quality Control of biological products, driven and guided by scientific evidence and technological innovations. The WHO Draft Guidance, Guidelines on the Replacement or Removal of Animal Tests for Quality Control of Biological Products addresses the following topics:
- General considerations
- Adventitious agent testing
- Pyrogenicity and endotoxin testing
- Neurovirulence testing
- The transition for in vivo to in vitro potency testing
- Specific toxicity
- Innocuity testing
- Development and use of international and other biological reference standards
- Guidance for national regulatory authorities
On 08 October 2025, the Central Drugs Standard Control Organization (CDSCO) of India reported to the WHO the presence of Diethylene Glycol (DEG) in at least three oral liquid medicines. This followed information identified by WHO on 30 September 2025 of localized clusters of acute illness and child fatalities in India. CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children. The contaminated oral liquid medicines have been identified to be specific batches of COLDRIF, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma. CDSCO has confirmed that relevant state authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorizations. In addition, a recall of the contaminated products has been initiated by relevant state authorities
The CDSCO has informed WHO that none of the contaminated medicines have been exported from India and there is currently no evidence of illegal export. Nevertheless, WHO encourages National Regulatory Authorities (NRAs) to consider targeted market surveillance, with particular attention to informal and unregulated supply chains where products may circulate undetected. NRAs are also advised to carefully evaluate the risks associated with any oral liquid medicines originating from the same manufacturing sites, particularly those produced since December 2024.
This WHO Medical Product Alert refers to falsified SIMULECT (basiliximab) for injection. The falsified product has been detected in Rwanda, Bulgaria, and Turkey, and was reported to the WHO in December 2024 and November 2025. SIMULECT (basiliximab) is an immunosuppressant medicine classified as a monoclonal antibody. It is indicated for the prevention of acute organ rejection in adults and children undergoing kidney transplantation. SIMULECT is supplied as a powder vial with or without a water for injection (solvent) ampoule for reconstitution and is administered either as an intravenous infusion or as an injection, usually in a hospital setting.
This product is falsified because it deliberately misrepresents its identity, composition, and source. The genuine manufacturer has confirmed that the products listed in this alert are falsified. A sample of the falsified product was forensically tested by the genuine manufacturer and found to contain no active pharmaceutical ingredients; instead, it contained ascorbic acid. The genuine manufacturer also identified several visual discrepancies on the packaging:
- Batch number: The falsified product shows batch number SFYD2, which is not a valid batch number for SIMULECT. Any SIMULECT product with batch number SFYD2 should be considered falsified.
- Folding box and label information: The falsified product label displays the National Drug Code NDC 0078-0331-84. While the National Drug Code (NDC) is a unique identifier for medicines marketed in the United States of America, the label contains other discrepancies compared to genuine SIMULECT packaging.
- The genuine product lists the ingredient dose in milligrams using “mg,” while the falsified product uses “MG”.
- The genuine product lists the country of manufacture as “Product of France” while the falsified product lists the country of manufacture as “Product of Switzerland or France”.
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