SQA Regulatory Surveillance Summary for Q2 2025 | Pharmaceutical Regulatory News
This edition of the pharmaceutical regulatory news summary highlights key global developments impacting pharmaceuticals, medical devices, and compliance. The update covers enforcement actions, safety alerts, and regulatory guidance issued by major health authorities including ANVISA, FDA, EMA, NMPA, MHRA, Health Canada, WHO, and others, offering timely insight into evolving regulatory expectations worldwide.
SQA Regulatory Surveillance Summary | Monthly Update 2023 – January
SQA Regulatory Surveillance Summary for January 2023 By: Laurel Hacche, Rocio Cabeza, and Debra Cortner China: National Medical Products Administration (NMPA) NMPA Announcement on putting into use the electronic certificates of Documentation for Export of Active Pharmaceutical Ingredients (APIs) to the European Union (EU) and Certificate of a Pharmaceutical Product (No. 95, 2022), 08 November […]
SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October
SQA Regulatory Surveillance Summary for September and October 2022 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA’s Questions & Answers (Q&A) on Medical Cannabis for Clinical Investigations, 14 September 2022 ANVISA published answers to questions received during an online seminar on clinical research of medicinal cannabis held in May 2022. The 20-page Q&A document covers general and specific topics including the importation of cannabis […]
SQA Regulatory Surveillance Summary | August 2020
By Laurel Hacche and Debra Cortner, SQA Associates European Pharmacopoeia (Ph. Eur.) Recombinant Factor C: New Ph. Eur. Chapter, 01 July 2020 Published in Ph. Eur. Supplement 10.3, the new general chapter 2.6.32., “Test for bacterial endotoxins using recombinant factor C,” describes a test for bacterial endotoxins (BET) that can be used as an alternative to the […]
Medical Device Regulations & Regulatory Surveillance Summary – June 2020
This regulatory surveillance summary highlights key global regulatory developments from June 2020, including updates to Medical Device Regulations, guidance documents, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, June 2020 US FDA is publishing a […]
COVID-19 & Regulatory Surveillance Updates – May 2020
This regulatory surveillance summary reviews key global regulatory developments from May 2020, including covid-19 guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations and Guidances Health Canada Announces Another Step to Accelerate Access to Health Products for COVID-19, 27 May 2020 The COVID-19 pandemic has led […]
Regulatory Surveillance Summary | March 2020
By Laurel Hacche and Debra Cortner, SQA Associates Personal Care Products Council Personal Care Products Council (PCPC) COVID-19 Summary, 20 March 2020 In an effort to comply with health authorities’ recommendations for social distancing and in an abundance of caution, PCPC has closed their offices, and staff is working remotely to maintain business continuity and […]
Drug Recall Updates: Regulatory Surveillance Summary – December 2019
This regulatory surveillance summary reviews key global regulatory developments from December 2019, including drug recall actions, FDA warnings, and compliance updates. By Laurel Hacche, SQA Associate United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations, October 2019 This […]