SQA Regulatory Surveillance Summary for 3Q/4Q 2024

By: Laurel Hacche and Debra Cortner

As we move through 2025, looking back at regulatory updates from Q3 and Q4 of 2024 provides critical insight into how the global compliance landscape is evolving.

This summary highlights significant shifts from agencies like ANVISA, the FDA, EMA, NMPA, and others, covering cosmetics surveillance, Artificial Intelligence in medical devices, and updated GMP practices.

Many of these changes laid the groundwork for 2025’s current regulatory direction, from stricter post-market monitoring to supply chain resilience and AI literacy requirements.

Agência Nacional de Vigilância Sanitária (ANVISA)

ANVISA Publishes Second Version of the Guide for Determining Food Expiration Dates, 03 July 2024

On 03 July 2024, ANVISA made a new comprehensive guide available for the determination of the expiration dates of food marketed in Brazil. This document, which takes effect immediately, aims to improve food safety standards and was developed based on recognized international references. The guide establishes guidelines based on best regulatory practices, including contributions from authorities from Australia, New Zealand, and the International Alliance of Dietary/Food Supplements Associations (IADSA). In addition, the guide incorporates conservation technologies recommended by the Pan American Health Organization (PAHO) and the European Food Safety Authority (EFSA). The guidelines contained in this document will be available for contributions for 180 days.

ANVISA Publishes New Rules for Post-Market Monitoring of Cosmetics, 03 September 2024

On 27 August 2024, ANVISA published the Resolution of the Collegiate Board (RDC) 894, which establishes the guidelines of Good Cosmetovigilance Practices for cosmetic product companies. The new regulation aims to improve the monitoring and safety of cosmetics in the Brazilian market, ensuring that any health risks are identified and managed in a timely and effective manner. Thus, its publication represents a significant advance, as it reinforces ANVISA’s commitment to protect the health of consumers and ensure the quality of the products available on the market. The main points of RDC 894/2024 are:

Clear definition of the responsibilities of cosmetics companies in the post-marketing monitoring of their products.
Establishment of a robust cosmetovigilance system, consisting of at least six mandatory minimum requirements, which guarantee, among other aspects, the performance of procedures for the collection, evaluation, investigation, and notification of serious adverse events.
Mandatory designation, by each company, of a professional responsible for cosmetovigilance.
Determination of deadline for notification of serious adverse events to ANVISA.
Inclusion of definitions for several technical terms, such as cosmetic surveillance, severe adverse event, cosmetic surveillance system, and cosmetovigilance inspection.
Implementation of risk minimization measures by companies when safety problems with cosmetic products are identified.

ANVISA Warns of Risk of Using Stem Cell-Based Products without Approval, 24 September 2024

To protect the health of patients and ensure that the treatments offered follow current standards, avoiding risks and damage to health, ANVISA is intensifying the inspection of the use of advanced therapy products. The inspection is particularly focused on products based on cultured stem cells, which are not registered or approved for clinical trials by the Agency. ANVISA published Resolution RE 3,402/2024, adopting inspection measures for the company R-Crio Criogenia S/A (CNPJ 19.208.189/0001-30), for the therapeutic use of mesenchymal stem cells in Brazilian patients. ANVISA found the use of this product in eight patients, in opposition to current legislation. ANVISA has received complaints about the inappropriate use of stem cells grown and used indiscriminately, without safety and quality criteria in place. Patients are promised cures and deceptive treatments for serious diseases such as Parkinson’s, Alzheimer’s, HIV infection, and cancer, as well as aesthetic treatments, without any scientific support or controlled studies. ANVISA warns that treatments with advanced therapy products that do not have the proper authorization of the institution should not be used, as this may put the lives and health of patients at risk.

ANVISA, Federal Police, and Health Surveillance of Foz do Iguaçu Inspect Aesthetic Clinics, 11 October 2024

An inspection performed by ANVISA, the Federal Police, and the Health Surveillance of Foz do Iguaçu in aesthetic clinics found several irregularities. The joint action occurred on 08 October 2024. Two aesthetic clinics in Paraná were closed. The agents found several irregularities, including the use of products without proper regularization in the Agency, disregard for health standards, and the illegal practice of medicine. In recent years, ANVISA has found that aesthetics and beautification services appear as the most denounced and claimed an average of 60% of complaints. The Agency recommends that the user check the legality of these clinics and the training of professionals before performing any type of procedure to avoid risks of health complications such as allergies, inflammatory reactions, infections, and even the risk of death.

China: the National Medical Products Administration (NMPA)

China’s NMPA Proposes Medical Device Administration Law, 13 September 2024

On 28 August 2024, the NMPA in China released the draft Medical Device Administration Law (MDAL) for public comment. Since 2001, the framework legislation for medical devices has been a regulation, the Medical Device Supervision and Administration Regulations (MDSAR), which was last amended in 2021. If enacted by China’s National People’s Congress’s Standing Committee, the Draft MDAL would elevate the device framework legislation to the level of law. Although the Draft MDAL preserves the basic structure of the MDSAR, which covers the lifecycle of medical devices, from research and development to post-market surveillance, the Draft MDAL is more comprehensive in its regulation of each stage and codifies regulatory reforms over recent years (e.g., those on custom medical devices). Some of the notable developments in the Draft MDAL include the following:

One of the challenges for registrants of medical devices in China is the need to comply with a long list of medical device standards, including mandatory national standards and agency-level industrial standards. Since 2017, China’s National Standardization Law has provided that industrial standards are voluntary standards. However, in practice, the NMPA expects compliance with industrial standards. In contrast to the currently effective MDSAR, the Draft MDAL expressly states that industrial standards are voluntary, and it will allow companies to follow an international standard if the standard sets a higher requirement. Whether these changes would result in a change in practice by the NMPA is unclear.
Like the MDSAR, the Draft MDAL retains a distinction between imported and domestically produced products. Under current rules, key differences for imported product registration applications include the requirement to provide proof of foreign approval in the applicant’s name and the requirement to appoint a domestic agent. The Draft MDAL appears to remove the first requirement for proof of foreign approval although whether it will be maintained in implementing rules is unclear and also appears to increase the required credentials for domestic agents. Specifically, the agents for overseas registrants would need to have either device distribution licenses or device manufacturing licenses. The Draft MDAL also more clearly and expressly states that those agents would be jointly liable with the overseas device registrant.

The European Commission (EC)

EU Publishes Regulation Governing Use of AI in Medical Devices and IVDs, 15 July 2024

The EC has published the finalized text of the Artificial Intelligence Act (AIA), which establishes a legal framework to promote the uptake of human-centric, trustworthy AI for medical devices, in vitro diagnostic devices (IVDs), and other products. The Act also sets harmonization rules for placing products on the market. According to the European Parliament, it is the world’s first comprehensive AI law. The AIA was published in the Official Journal on 12 July 2024 and will go into effect on 02 August 2024, while the requirements for high-risk devices will go into effect on 02 August 2026.

The Act aims to improve the functioning of the internal market, prohibits certain AI practices, and adds specific requirements for high-risk AI systems. It does not apply to research or testing activities prior to placing products on the market. The regulation also mandates that providers and deployers of AI systems provide a sufficient level of AI literacy to their staff.

EU Commission Releases Assessment of the Supply Chain Vulnerabilities for the First Tranche of the Union List of Critical Medicines, 06 August 2024

On 10 July 2024, the European Commission’s Health Emergency Preparedness and Response Authority (HERA) published a technical report evaluating vulnerabilities in the supply chain for medicines listed in the Union List of Critical Medicines. This report is expected to provide valuable insights to the Critical Medicines Alliance (CMA), the EU Commission, and EU Member States in order to respond better to potential supply shortages. In December 2023, the first version of the Union List of Critical Medicines was published, containing more than 200 active substances classified as critical due to their therapeutic purposes and the accessibility of appropriate substitutes. Further information can be found in the news article regarding the Union List of Critical Medicines. After the publication of the Union List, a pilot exercise was conducted to evaluate the supply chain weaknesses of an initial group of 11 critical medicines. The findings are as follows:

Non-EU Active Pharmaceutical Ingredient (API) suppliers: Dependence on non-EUAPI suppliers leads to a significant risk of supply chain disruption in the event of production issues.
Market Concentration Risks: If the majority of supply originates from a single country or manufacturer, the risk of supply chain disruption from geopolitical problems, trade restrictions, or production issues increases.
Variable Production Resilience: Diversification of production sites is essential in reducing the risk of localized supply disruption and to ensuring resilient supply chains.
Uncertainty in Market Dynamics: The unpredictable demand for critical medicines leads to vulnerability to fast changes in demand. In order to adapt to rapid market changes, supply chain systems are required to be more flexible and adaptive.
Economic Viability Challenges: Economic challenges threaten the long-term sustainability and profitability of the substances. Tackling these issues is key for maintaining strong supply chains.

The above findings indicate that strategic measures are necessary to increase the resilience of the supply chain by diversifying sources of supply, increasing the flexibility of production capacity, and creating robust risk management measures to successfully manage economic and market fluctuations. Shortages of essential medicinal products are mainly caused by manufacturing problems and unexpected surges in demand.

MDCG Clarifies How Ethylene Oxide is Regulated Under MDR, IVDR, 29 October 2024

The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance on how the medical technology industry should handle ethylene oxide (EtO) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The sterilizing gas is widely used by the medical technology industry to clean products, largely due to its ability to penetrate small spaces. The MDCG EtO guidance refers to specific sections of the MDR and IVDR when using EtO and considering international standards. MDCG lists several other parts of MDR and IVDR that detail general safety and performance requirements related to device sterilization that can be met with certain international standards. The MDCG also lists technical documentation, qualification requirements of notified bodies, and conformity assessment procedures underlined in the regulations. The guidance also states that EtO is often used by health institutions to sterilize reusable devices before and after use. In such cases, the EtO cartridges used to sterilize the products are considered medical devices and fall within the scope of MDR requirements.

The European Medicines Agency (EMA)

Euro Roundup: the EMA Seeks Feedback on Revised Guidelines on the Chemistry of Active Substances, 01 August 2024

The European Medicines Agency (EMA) has begun a consultation into proposed changes to its guidelines on the chemistry of active substances. The EMA’s planned updates include revisions related to nitrosamines. The EMA’s Committee for Medicinal Products for Human Use adopted the current version of the guidelines in 2016. That document describes the type of information required for the manufacture and control of existing or new chemical entities used in medicinal products. In 2022, the EMA outlined the need to revise the guidelines to reflect recommendations to reduce the risk of nitrosamines and to help the EMA’s regulatory network be better prepared to manage future cases of unexpected impurities. Updates to the guidelines include the following:

Evaluating the risk that nitrosating agents or amines will contaminate raw materials such as reagents, catalysts, and solvents (including water)
Accessing the impurity profile of fermented or extracted starting materials
Requirements for control of starting materials of animal or human origin

New Pilot Program to Support Orphan Medical Devices, 02 August 2024

The EMA has launched a pilot program for expert panels to support the development and assessment of orphan medical devices in the EU. The pilot program offers free advice from the medical device expert panels to selected manufacturers and notified bodies on the orphan device status and the data needed for their clinical evaluation. While the pilot program is currently scheduled to run until the end of 2025, the aim is to establish a long-term process for orphan device support. Manufacturers can consult the expert panels at different stages of the development of the clinical strategy for their device, while notified bodies can request advice at specific moments of the ongoing conformity assessment of the device. As part of the pilot program, the EMA will prioritize certain types of orphan medical devices, such as devices for treating a medical condition that is life-threatening or that could cause permanent impairment of a body function, devices intended for children, and novel devices with potential major clinical benefit.

EMA Issues New Draft Guidelines: Chemistry of Active Substances, 03 September 2024

To improve the new drug submission process in relation to the active substance, on 09 July 2024, the European Medicines Agency (EMA) issued a new draft guideline, titled Guideline on the Chemistry of Active Substances. The draft guideline relates to granting a marketing authorization for a medicinal product. Once the final version is issued, the guidelines will replace two existing documents: Note for Guidance on Chemistry of New Active Substances (CPMP/QWP/130/96, Rev 1) and Chemistry of Active Substances (3AQ5a). Hence, the new document will bring together new and existing active substances into one set of guidelines. The main purpose of the new guidelines is to detail the requirements for a new drug or modified drug application. Requirements include the following:

General information
Manufacturing
Characterization
Control of the active substance
Reference standards or materials
Container closure system
Stability

EMA Publishes EU Strategy to 2028, 10 October 2024

A draft joint EU network strategy has been published by the EMA and the Heads of Medicines Agencies (HMA). This updated strategy replaces the original five-year strategy, which was developed to cover the period from 2021 to 2025 (EMANS 2025). The draft strategy covers the following focus areas up to 2028:

Accessibility to support pathways for medicine access in the EU
Leveraging data, digitalization, and Artificial Intelligence (AI)
Creating a regulatory and research environment that improves innovation and competitiveness in EU healthcare
Preparing the EU for potential threats, such as Antimicrobial Resistance (AMR)
Strengthening the EU’s medicine supply
Ensuring that the network has available resources to support its scientific and regulatory decision-making

Health Canada

Unauthorized Treatments Provided by Individual Posing as a Practitioner at MedSkin Laser Center in Sherwood Park, Alberta, May Pose Health Risks, 02 August 2024

Health Canada is warning the public about the following unauthorized treatments, which were being administered at MedSkin Laser Center in Sherwood Park, Alberta, where the owner and operator of the clinic was posing as a practitioner without the necessary qualifications:

Unauthorized Platelet Rich Plasma (PRP) treatments:
Facelift, neck, and decolletage
Facelift with microneedling
Plasma bio filler
Hair restoration
Vampire breast lift and facial
O-Shot
Unauthorized Platelet Rich Fibrin (PRF) for scalp, eyes, acne, face, neck, jawline, hands, and decolletage
Botox
Unauthorized microneedles and microneedle tips
Unauthorized plasma pen

The above list includes unauthorized Platelet Rich Plasma (PRP) treatments for hair restoration, breast enhancements, rejuvenating skin and muscles, wound healing, and face lifts. Unauthorized PRPs could lead to serious health risks, including the potential transmission of infectious diseases, contaminants, and toxic effects. Health Canada also seized prescription Botox from the MedSkin Laser Center, because prescription drugs should only be given by a healthcare professional with the appropriate qualifications and experience. Using prescription drugs without a proper prescription and the advice of a qualified practitioner could lead to serious harm, including side effects, allergic reactions, severe complications, and other medical issues. Finally, the department also seized unauthorized medical devices, including microneedles, microneedle tips, and a plasma pen.

Poppers are Unauthorized and May Pose Serious Health Risks, 07 August 2024

Health Canada is advising about unauthorized products promoted as “poppers,” which may pose serious health risks. “Poppers” is a slang term for products that contain alkyl nitrites. Despite being labelled for various uses such as leather cleaners, room deodorizers, or liquid incense, these products are inhaled or ingested by consumers for recreational purposes. Alkyl nitrites, such as amyl nitrite, butyl nitrite, and isobutyl nitrite are prescription drugs and should be used only under the supervision of a healthcare professional. Products containing alkyl nitrites may pose serious risks, including death, depending on the amount used, how frequently they are used, and how long they are used for, as well as the person’s health and other medications they may be taking. Since it is difficult to control how much is inhaled, people can accidentally overdose. Swallowing these products can lead to serious medical complications and may be fatal. People with certain medical conditions (including recent head trauma, bleeding into the head, glaucoma, or heart disease) and those taking certain medications (particularly drugs used to treat erectile dysfunction, and high blood pressure medications, certain migraine drugs, and high doses of aspirin) or illicit drugs are at particular risk. Unauthorized “poppers” include, but are not limited to, the following:

Dolce Detersive Bello
Amsterdam and Gold Label Amsterdam
Blue Boy Original
Double Scorpio Rose Gold
English Royale
Jungle Juice Platinum
Pig Sweat
Rochefort
Rush Original, Rush Power Pak, and Super Rush

Non-Compliant Inspection Rating for A&L Canada Laboratories Inc., 04 September 2024

A&L Canada Laboratories Inc., located in London, Ontario, received a non-compliant rating from a GMP domestic inspection that started on 04 September 2024. Key findings included the following observations:

Inadequate controls for receipt, preparation, and/or handling of reagents and culture media
The expiration date of culture media was not supported by growth-promotion testing
Inadequate controls for calibration, inspection, and/or qualification of equipment, including computerized systems
Inadequate controls for monitoring water testing
Inadequate ongoing training, GMP training, and training related to maintenance of records
Sanitation programs were not adequately designed to identify and/or reduce risk of contamination
Handling of Standard Operating Procedures (SOPs) for GMP activities was inadequate

Guide to Validation of Terminal Sterilization Process of Drugs (GUI-0074), 12 November 2024

The Guide to Validation of Terminal Sterilization Process of Drugs (GUI-0074) is for fabricators of sterile drugs. It provides guidance on how to establish the scientific effectiveness of terminal sterilization processes. The guide provides users with the requirements to comply with Part C, Division 2 of the Food and Drug Regulations and mainly refers to the requirements for the following:

Manufacturing Control (sections C.02.011 to C.02.012)
Quality Control Department (sections C.02.013 to C.02.015)
Sterile Products (section C.02.029)

The Guide to Validation of Terminal Sterilization Process of Drugs (GUI-0074) should be read along with the current editions of the following guidance documents:

Asia-Pacific Roundup: Indian Pharmacopoeia Seeds Feedback on Disinfecting Drug Production Plants, 28 October 2024

The Indian Pharmacopoeia Commission (IPC) has released for consultation a draft guidance on the use of disinfectants and antiseptics in drug manufacturing facilities. The document is an updated version of the drafts for consultation IPC published in March and July of 2024. IPC has retained the core content of the document throughout rounds of feedback and revisions because they believe that a sound cleaning and sanitization program is needed for controlled environments used in the manufacture of pharmaceutical articles to prevent the microbial contamination of these articles. The draft guidance addresses the use of antiseptics to decontaminate human skin and exposed tissue, chemical sterilants to decontaminate surfaces in manufacturing and sterility testing areas, and UV irradiation as a surface sanitizer. The text discusses choosing chemical disinfectants, antiseptics and sterilants; showing bactericidal, fungicidal, and sporicidal efficacy; using the agents; and regulatory and safety considerations.

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidances – Quality, Efficacy, Multidisciplinary, and Safety

The ICH M13A Guideline Reaches Step 4 of the ICH Process, 31 July 2024

The ICH M13A Guideline and associated Q&As on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 4 of the ICH Process on 23 July 2024. This guideline provides recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid oral dosage forms. The Q&A document is intended to provide additional clarification and to improve harmonization of bioequivalence study design and data analysis.

ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video Now Available on ICH Website, 24 October 2024

The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for the Clinical Studies Introductory Training Video. The video is available for download and can be found in the ICH Training Library.

ICH Q9(R1) IWG Updated Q9(R1) Annex 1 – Q8/Q9/Q10 Questions and Answers, 06 December 2024

The ICH Secretariat is pleased to announce the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions and Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM). The ICH Assembly approved this updated Q9(R1) Annex 1 on 30 October 2024. The Q&As have been updated by removing outdated text and rephrasing Q&As in view of the implementation of ICH Q8, Q9, and Q10, with minor additions to address minor content gaps. Minor edits have also been made to improve the readability of the document.

International Pharmaceutical Excipients Council (IPEC) Federation

Updated: IPEC Good Distribution Practices (GDP) Guide, 08 October 2024

The IPEC Federation announced the publication and availability of a comprehensive update to the IPEC Good Distribution Practices Guideline for Pharmaceutical Excipients (version 3, 2024), jointly developed by a team consisting of members from IPEC Europe and IPEC-Americas. The IPEC Good Distribution Practices Guideline has proven to be an important element in the supply chain management and control of pharmaceutical starting materials. The updated guide provides a comprehensive tool for companies operating within the supply chain of pharmaceutical excipients. Several serious incidents in the past, and more recently over the past two years, resulted in the deaths of many children was caused by a lack of supply chain security, inappropriate handling of pharmaceutical excipients, and falsification of records. This has moved regulators, users, manufacturers, and distributors to take action. Please also refer to the IPEC Federation Position Paper on Latest Fatal Incidents with Contaminated Medicinal Syrup During 2022/2023, August 2023.

International Society for Pharmaceutical Engineering (ISPE)

GAMP Good Practice Guide: Computerized GCP Systems and Data, 2^nd Edition, July 2024

Advances in digital health, increased regulatory scrutiny, and the integration of new technologies such as Artificial Intelligence (AI) and new models such as decentralized trials have been accelerated by the COVID-19 pandemic. In light of this, the content of the ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data has been significantly expanded to foster a robust validation framework to help support the integrity and efficiency of clinical trials. The guide discusses the increased complexity of hybrid or participant-centric decentralized trials. The guide describes best practices for managing this complexity, which is caused by various factors such as a greater reliance on contractor/subcontractor processes and the use of participant-owned digital health technologies and devices (like smart phones).

ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (2^nd Edition), September 2024

The need to update the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) has become increasingly evident since its original publication in 2009 as options available to HVAC designers and engineers have evolved due to technological advancements and shifting project pressures. The second edition of the guide reflects these changes, providing readers with a more current perspective on the challenges and resources involved. The second edition aims to clarify Good Manufacturing Practice (GMP) HVAC issues that are critical to the safety, identity, strength, purity, and quality of pharmaceuticals, biopharmaceuticals, advanced therapy medicinal products, and medical devices, from raw materials to finished products. It covers HVAC control and monitoring requirements and addresses Good Engineering Practice (GEP) issues related to sustainability, economics, and environmental health and safety. The guide provides best practices for implementing international regulatory and industry guidelines, with appendices containing industry examples and templates for the reader’s reference.

Good Practice Guide: Ozone Sanitization of Pharm Water Storage and Distribution Systems, 2^nd Edition, October 2024

The updated Good Practice Guide: Ozone Sanitization of Pharm Water Storage and Distribution Systems, published in October 2024, offers comprehensive guidance on designing and operating pharmaceutical water storage and distribution systems that utilize ozone for sanitization. It outlines key principles for implementing an effective sanitization approach. The key advantages of ozone sanitization discussed in this Second Edition include the following:

Improved water quality reliability
Higher productivity
Capital equipment savings
Safety
Pipe insulation
Reduced energy costs
Reduced carbon footprint
Advantages over chemical sanitization
Reduced system downtime
Ease of frequent use
Reduced excursions and related cost
Reduced water consumption
Reduced chemical disposal costs

Medicines and Healthcare Products Regulatory Agency (MHRA)

Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500 mg Tablets (voxelotor), EL(24)A/44, 30 September 2024

Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies suggesting an unfavorable imbalance in the number of vaso-occlusive crises and fatal events in patients treated with Oxbryta. Oxbryta is indicated for the treatment of haemolytic anaemia due to Sickle Cell Disease (SCD) in adults and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide. Treatment is only initiated by physicians/specialist prescribers experienced in the management of SCD. The information in this recall reinforces action already being undertaken by Pfizer Limited and ensures that healthcare professionals in National Health Service (NHS) Trusts and other care settings take appropriate action to recall all batches from patients as soon as possible. The recall notification is being shared with all healthcare professionals in the event that any patients experience any adverse events and require appropriate medical attention.

Statutory Instrument Laid in Parliament Provides First Regulatory Framework of its Kind that Will Transform the Manufacture of Innovative Medicines at the Point of Patient Care, 21 October 2024

A Statutory Instrument (SI) laid in Parliament on 21 October 2024 will provide a new regulatory framework. This means that medicines with a very short shelf life and highly personalized medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly. The regulation will also allow for the manufacture of innovative medicines in small, portable units that can be set up close to patients who may be too sick to travel, whose reduced immunity precludes travel, or where rapid medicine availability is best served. This novel UK regulatory framework will transform patient treatment by enabling the safe development of innovative, personalized products such as cell or gene therapy that need to be manufactured close to the individual patient. It will help relieve pressure on hospitals by enabling delivery of care where it is most appropriate for the patient, in community settings or even in their homes, supporting the ambition to expand hospital at-home services such as virtual wards. The legislation proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in the summer of 2025.

The MHRA Issues Final Call to Comply with Windsor Framework Arrangements for Medicines from January 2025, 29 November 2025

On 29 November 2025, the MHRA announced that the vast majority of companies have already submitted updated artwork to ensure compliance with the new arrangements for medicines following the Windsor Framework, as the MHRA issues its final call to marketing authorization holders to take action now to prepare for the 31 December 2024 deadline. As of 01 January 2025, the MHRA will be responsible for licensing all medicines on the market in Northern Ireland under a UK-wide license. All medicines for the UK market must bear a “UK Only” label or sticker to show that they are only for sale within the UK and not in countries inside the European Union (EU). Any companies that still need to submit updated artwork should do so as soon as possible, and before releasing products on the market in the new year. Transition measures are also in place and medicines released to the market before 01 January 2025 will still be allowed to be supplied without the new labelling until they reach their expiry date.

Parenteral Drug Association (PDA) – Technical Reports and Guidances

Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users, August 2024

PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment by going beyond manufacturer-focused issues and addressing issues specifically encountered within the last mile of the distribution of medicinal products and devices. This revision updates the original 2009 technical report to account for expanded regulations, the development and implementation of newer, more advanced technologies and supply chains that have become more extensive and complex.

“Last mile distribution” is an often-used logistical term that refers to the transport of products from the manufacturing facility to the end user. For the purposes of this technical report, the “last mile” is defined as the final transfer of a drug from the manufacturer or wholesaler to the end user, which could refer either to the patient or the entity (e.g., pharmacy, hospital) that provides the drug to the patient. Transfers earlier in the distribution process involve organizations with greater knowledge of the product and the resources to ensure carefully controlled conditions of storage and transport compared to those available to the end user. As such, PDA Technical Report No. 46 provides recommendations and tools based on current best practices to ensure that product quality is maintained in the last mile, including guidelines on temperature control, monitoring and security, and data management, with a focus on supply chain management. It also covers supply chains in Europe, Africa, Brazil, the U.S., Canada, and China.

GMP Validation: A Guide to International Regulatory Requirements, September 2024

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between various regulatory agencies and the recommendations of different standards can be bewildering. This book seeks to provide a map for navigating the choppy waters of international regulations. GMP Validation: A Guide to International Regulatory Requirements is intended for those who need to assess validation and ensure that validation is conducted according to current GMP. Affected personnel include the validation manager and personnel engaged in validation activities such as Quality Assurance, Quality Control, Research and Development, and production personnel. Some of the guide’s scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those tasked with auditing validation systems, items of equipment, or processes.

The Personal Care Products Council (PCPC)

Counterfeit Cosmetics: How to Protect Yourself, 25 September 2024

There has been an uptick in the sale of counterfeit products, including counterfeit cosmetics, on e-commerce and other online platforms. The result is that unsuspecting consumers purchase phony products, which may cause disappointment; however, the purchase and use of counterfeit cosmetics could also lead to devastating results such as allergic reactions, skin irritation, chemical burns, eye infections, and more severe health issues. PCPC member companies invest substantial resources to ensure the safety and quality of their products and to meet federal and state safety and quality requirements. Fake cosmetics are produced illegally and without adherence to safety and quality requirements. Fake cosmetics may also be manufactured in unsanitary conditions. According to reports from the U.S. Department of Homeland Security, the FBI, and the Organization for Economic Cooperation and Development (OECD) phony beauty products can contain known carcinogens, including arsenic, beryllium, and cadmium, along with high levels of aluminum, mercury, and dangerous levels of bacteria. Consumers can reduce the risk of purchasing counterfeit beauty products when shopping online by:

Purchasing from a reputable seller: Buy directly from a brand’s website or an authorized online retailer. Carefully research third-party sellers from online marketplaces.
Reading the customer reviews: Check for inconsistencies in product reviews from third-party vendors. A great deal is often too good to be true.
Inspecting the packaging: Fake products can be indistinguishable from the actual product, so it’s important to look for any red flags, such as misspellings, differences in design, wrong serial numbers, and use-by dates.
Spot-testing the product: Test a small amount of the product on your skin to check for any allergic reactions or irritation.

If you get duped despite your best efforts to protect yourself from counterfeit cosmetics, contact the vendor or online platform and request a refund. If you’ve used a credit card for the purchase, contact your credit card company to investigate the purchase and leverage their purchase protection policy, if applicable. You can also report counterfeits at STOPfakes.gov.

Pharmaceutical Inspection Co-Operation Scheme (PIC/S)

Adoption and Entry into Force of Guidance Documents on Remote Assessments, 13 December 2024

PIC/S has published the following two guidance documents for inspectors that will enter into force on 01 January 2025:

PI 056-1 is intended to provide guidance on the approach and use of remote assessments, including hybrid inspections as tools to establish consistency amongst Inspectorates. PI 056-1 addresses the following:

Logistics for remote assessments
Feasibility approach to remote assessments
Remote assessment documentation
Follow-up on remote assessment effectiveness

PI 057-1 is intended to assist GMP inspectors in the life cycle process of remote assessments. Parts of this aide-memoire may also be useful (with suitable modification) during other GXP remote assessments, where similar principles apply. This aide-memoire should also foster reliance and contribute to a harmonized approach for remote assessments between different PIC/S members. PI-057-1 addresses the following:

Preparation for a remote assessment
Conduct of the remote assessment
Post-assessment activities for a remote assessment

Therapeutic Goods Administration (TGA)

Nitrosamine Impurities Acceptable Intakes Update, 30 July 2024

The TGA has published updated Acceptable Intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include minor editorial amendments, increases to the AI limit for a nitrosamine impurity, and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines. Sponsors and manufacturers are expected to be familiar with the current AIs for nitrosamine impurities in medicines that the TGA considers acceptable. Visit the Established Acceptable Intake for Nitrosamines in Medicines page for the updated list of established acceptable intake for nitrosamines in medicines. Updated information on this issue will be published as it becomes available.

Medtronic Australasia Pty Ltd Ordered to Pay $22 Million – the Largest-Ever Penalty for Unlawful Supply of Therapeutic Goods, 19 September 2024

The Federal Court of Australia has ordered Medtronic Australasia Pty Ltd (Medtronic) to pay $22 million in penalties for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 01 September 2015 and 31 January 2020. The Court’s judgment comes after the TGA commenced proceedings against Medtronic in August 2021. The Court has also ordered that Medtronic pay $1 million as a contribution to the TGA’s legal costs. This penalty is the largest ever imposed for contraventions of the Therapeutic Goods Act 1989 (Cth). Australian law generally requires that therapeutic goods are entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia. While the Infuse Bone Graft Kit was entered in the ARTG for supply with a separately packaged spinal cage (the LT Cage), that entry in the ARTG did not allow the Kit to be supplied without the LT Cage. Medtronic unlawfully supplied the Kit without the LT Cage.

Recall Reforms Update and New Procedure, 20 December 2024

The TGA is providing sponsors with advance notice of the final package of the recall reforms that will be implemented in early March 2025. This includes providing a preview of Australia’s new recall procedure, which will be known as the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC). Sponsors will continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until early March 2025, at which time the URPTG will be replaced by the PRAC. The PRAC will:

Enhance the transparency, communication, and timeliness of recalls, alerts, and corrections.
Introduce new market action terminology, reducing the number of categories from eight to four.
Halve the number of steps in the process from 10 to five but without requiring any major changes to how sponsors approach the process.
Feature fewer pages with instructions, less repetition, and clearer information.

One of the most requested changes was to update the recall terminology, removing the sometimes-confusing categories of recall and non-recall actions, and replacing them with a single category for market actions.

The United States Food and Drug Administration (FDA) – Regulations and Guidances

Draft Guidance for Industry and Staff, Predetermined Change Control Plans for Medical Devices, August 2024

The FDA is issuing this draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on information to include in a PCCP in a marketing submission for a device. A PCCP is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance recommends that a PCCP for a device describe the planned device modifications; the associated methodology to develop, validate, and implement those modifications; and an assessment of the impact of those modifications. The FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this draft guidance apply to devices, including device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.

Guidance for Industry, Control of Nitrosamine Impurities in Human Drugs, September 2024

The FDA has announced the availability of a final guidance for industry entitled Control of Nitrosamine Impurities in Human Drugs. This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance describes two general structural classes of nitrosamine impurities: small-molecule nitrosamine impurities (i.e., nitrosamine impurities that do not share structural similarity to the API), and nitrosamine drug substance-related impurities (NDSRIs) that share structural similarity to the API and are generally unique to each API. The guidance discusses the potential root causes of the presence of nitrosamine impurities, detection of nitrosamine impurities, and recommendations for risk assessments, testing, and implementation of controls and other appropriate strategies to prevent or reduce the presence of nitrosamine impurities in APIs and drug products. Recommendations for an alternative bioequivalent approach if manufacturers and applicants decide to reformulate their products to mitigate nitrosamine impurities are also provided in the guidance. This guidance is a revision of the final guidance of the same name issued on 24 February 2021.

Drug Supply Chain Security Act – Waivers and Exemptions Beyond the Stabilization Period, 09 October 2024

On 09 October 2024, the FDA published the Drug Supply Chain Security Act (DSCSA) exemptions from certain requirements under Section 582 of the FD&C Act to connected trading partners. This exemption applies to any product transacted by eligible trading partners, or trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges exchanging data. The exemption is part of the agency’s broader efforts to avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need. The duration of the exemption varies depending on the eligible trading partners (listed below). Trading partners who utilize these exemptions do not need to notify the FDA.

Manufacturers and repackagers: 27 May 2025
Wholesale distributors: 27 August 2025
Dispensers with 26 or more full-time employees: 27 November 2025

Guidance for Industry: Unsanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination, October 2024

The FDA has issued guidance to address the potential for unsanitary conditions in the preparation, packing, and holding of tattoo inks to help tattoo ink manufacturers and distributors recognize situations in which tattoo ink may become contaminated with microorganisms, and thus be potentially injurious to health. The guidance also recommends certain steps that manufacturers and distributors could take to help prevent the occurrence of these conditions or to identify and remediate unsanitary conditions that already exist during manufacturing and distribution.

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, December 2024

The FDA guidance for Registration and Listing of Cosmetic Product Facilities and Products provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to the FDA. This guidance document describes, among other things, the following:

The statutory requirement to submit cosmetic product facility registrations and product listings
Definitions
Who is responsible for making the submissions
What information to include in the submissions
How to make the submissions
When to make the submissions

The United States Food and Drug Administration (FDA) – Recalls

Sierra Stain Recalls Tattoo Pigments Because of Possible Health Risk, 24 August 2024

Sierra Stain LLC of Carson City, Nevada is recalling three water-based tattoo pigments because they have been contaminated with high concentrations of microorganisms that present a health concern to consumers. Commonly reported symptoms associated with tattoo ink infections include the appearance of rashes or lesions consisting of red papules solely in areas where the contaminated ink has been applied. Some tattoo infections may result in permanent scarring. Symptoms can be difficult to recognize, as other conditions (e.g., allergic reactions) may also present with similar findings. The recall was initiated after the recalling firm became aware of the results of the samples collected and analyzed by the FDA, which tested positive for multiple microorganisms. The affected lots are packaged in plastic rounded bullet-shaped PET bottles with a black dispense screw top that were distributed to all 50 states through Amazon. No illnesses have been reported to date.

Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone, and Chlorpheniramine, 13 December 2024

Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone, and Chlorpheniramine. Furosemide was found at 5.24 mg/g or 1.84 mg/capsule. Dexamethasone was found at 2.22 mg/g or 0.780 mg/capsule. Chlorpheniramine was found at 4.38 mg/g or 1.54 mg/capsule. Products containing Furosemide, Dexamethasone, and Chlorpheniramine cannot be marketed as dietary supplements. Nhan Sam Tuyet Lien Truy Phong Hoan capsules are an unapproved drug for which safety and efficacy have not been established and, therefore, are subject to recall. This product is marketed as a dietary supplement for treatment for lumbago, gout, arthrodynia, myasthenia, limb numbness, pain induced by acclimation fever, and rheumatism, osteocope, and arthritis. The product is packaged in bottles containing 30 capsules each. The affected Nhan Sam Tuyet Lien Truy Phong Hoan capsules include all batches within expiration dates. Buy-herbal.com has not received any reports of adverse events related to this recall.

The United States Food and Drug Administration (FDA) – Warning Letters

Jiangsu Caina Medical Co., Ltd, Warning Letter, 18 July 2024

Jiangsu Caina Medical Co., Ltd received a Warning Letter on 18 July 2024. This Warning Letter was a result of the FDA’s review of the company’s responses to 483 observations that were issued during an on-site inspection conducted at the Jiangsu Caina Medical Co., Ltd. manufacturing facility located in Jiangyin City, Jiangsu, China from 11 to 23 March 2024. Jiangsu Caina Medical Co., Ltd. manufactures various medical devices, including Sterile Luer Lock Syringes without Needles and Sterile Enteral Syringes. The FDA review of the responses to the 483 observations provided concerns with respect to the following CGMP violations:

Failure to adequately establish and maintain procedures for Corrective and Preventive Action (CAPA).
Failure to establish and maintain procedures for validating device design, including risk analysis.

Concerns with respect to CAPA were related to investigations for customer complaints and subsequent recalls. Concerns with respect to device design and risk analysis were related to the use of specified syringes in infusion pumps and subsequent recalls.

Intercos Europe S.p.A, Warning Letter, 15 August 2024

Intercos Europe S.p.A received a Warning Letter on 15 August 2024. The Warning Letter was a result of the FDA’s review of the company’s response to 483 observations issued during an on-site inspection conducted at the Intercos Europe S.p.A manufacturing facility located in Agrate Brianza, Italy from 11 to March 2024. Intercos Europe S.p.A manufactures finished pharmaceutical products, including over-the-counter sunscreens. The FDA review of the responses to the 483 observations provided concerns with respect to the following CGMP violations:

Failure to test for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in raw material receipts of Glycerin
Inadequate investigations for microbial excursions
Lack of specific records for solvents utilized for analysis of Quality Control samples

Frontier Biologics, LLC, Warning Letter, 01 November 2024

Frontier Biologics, LLC received a Warning Letter on 01 November 2024. The Warning Letter was a result of the FDA’s review of the company’s regulatory submissions and the response to 483 observations issued during an on-site inspection conducted at the Frontier Biologics, LLC manufacturing facility located in Waco, Texas, U.S.A. from 27 February to 08 March 2024. Frontier Biologics, LLC manufactures a human amniotic fluid-derived product, Purified Fluid Allograft, as well as a human amniotic membrane-derived product, Allograft Matrix, for allogeneic use. The FDA Warning Letter cited the following concerns:

Unapproved new drug and unlicensed biological product violations
Failure to adequately validate manufacturing processes (including aseptic process validation)
Inadequate environmental monitoring program
Lack of validation for cleaning and disinfection for specified cleanrooms
Lack of investigation and determination of root cause for sterility failures
Assignment of product expiration dates without supporting stability data

The World Health Organization (WHO)

WHO Updates Laboratory Biosecurity Guidance, 04 July 2024

The WHO recently issued updated guidance for national authorities and biomedical laboratories to manage biological risks. New updates in the guidance include the strengthening of cybersecurity measures and handling of confidential information, such as patient records; reducing risks from new technologies, including those related to genetic modification and manipulation of pathogens and Artificial Intelligence (AI); and advice on keeping laboratories safe and secure during emergencies like wars, civil unrest, and disasters from natural hazards. The updated guidance also provides best practices and recommendations while encouraging member states to adopt a risk-based approach stipulated in the Resolution on Strengthening Laboratory Biological Risk Management adopted at the World Health Assembly this year.

WHO Guidance on Wastewater and Solid Waste Management for Manufacturing of Antibiotics, 03 September 2024

The WHO has published guidance on Wastewater and Solid Waste Management for Manufacturing of Antibiotics. This guidance has been requested by a myriad of international bodies, strategies, and reports. Its purpose is to provide an independent scientific basis for inclusion of targets in binding instruments to prevent the emergence and spread of antibiotic resistance. The target audiences for this guidance are regulatory bodies, procurers of antibiotics, entities responsible for generic substitution schemes and reimbursement decisions, third-party audit and inspection bodies, industrial actors and their collective organizations and initiatives, investors, and waste and wastewater management services. The guidance also includes best practices for risk management, including internal and external audit and public transparency. Crucially, this guidance includes progressive implementation and stepwise improvement, when needed, recognizing the need to protect and strengthen the global supply, and to ensure appropriate, affordable, and equitable access to quality assured antibiotics.

The regulatory developments from Q3 and Q4 of 2024 continue to influence how organizations approach compliance, risk mitigation, and global quality standards in 2025.

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SQA Regulatory Surveillance Summary for 3Q/4Q 2024