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 products, […]
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 […]
SQA Regulatory Surveillance Summary | July 2020
Coronavirus Regulatory Guidance and Emergency Measures – July 2020 This regulatory surveillance summary reviews key global regulatory developments from July 2020, including coronavirus guidance, emergency regulatory measures, and compliance considerations. By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 […]
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 […]