SQA Regulatory Surveillance Summary 3 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #3, 2021 European Commission (EC) – Biologics Commission Extends Transparency and Authorization Mechanism for Exports of COVID-19 Vaccines, 11 March 2021 The EC has extended until the end of June 2021 the transparency and authorization mechanism for COVID-19 vaccine exports. This […]
SQA Regulatory Surveillance Summary 2 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary #2, 2021 International Organization for Standardization (ISO) Clinical Investigation of Medical Devices for Human Subjects, ISO 14155:2020, November 2020 ISO 14155:2020 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to […]
SQA Regulatory Surveillance Summary 1 | Monthly Update 2021
By Laurel Hacche, Debra Cortner, & Dondi Pulse-Earle SQA Associates SQA Regulatory Surveillance Summary, #1 2021 Agência Nacional de Vigilância Sanitária (ANVISA) ANVISA has Published its Annual Management Plan (PGA) for 2021, which Comprises 61 Goals and Actions, 16 December 2020 The driving principles of the ANVISA Annual Management Plan (PGA) are to increase efficiency, […]
CBD Regulatory Updates & Regulatory Surveillance Summary – December 2020
This regulatory surveillance summary reviews key global regulatory developments from December 2020, including cbd regulatory guidance, enforcement considerations, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates SQA Regulatory Surveillance Summary for December 2020 European Commission New Technical Guidance on Cosmetic Hand Gels Addresses Antibacterial and Antiviral Claims, 25 November 2020 The European […]
Pharmaceutical Excipients Regulatory Updates & Surveillance Summary – November 2020
This regulatory surveillance summary reviews key global regulatory developments from November 2020, including updates impacting Pharmaceutical Excipients, regulatory guidance, and quality expectations. By Laurel Hacche and Debra Cortner, SQA Associates Association for the Advancement of Medical Instrumentation (AAMI) Remote-Controlled Hospital Devices Get COVID-19 Guidance, 28 October 2020 AAMI has published a new consensus report (CR), […]
Pharmaceutical Product Regulatory Updates & Surveillance Summary – October 2020
This regulatory surveillance summary reviews key global regulatory developments from October 2020, including updates affecting pharmaceutical product regulation, guidance documents, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates ANVISA (Agência Nacional de Vigilância Sanitária) There were no updates for ANVISA for October 2020. http://antigo.anvisa.gov.br/updates China Guidances and Regulations Regulation of Pharmaceutical Production […]
Healthcare Products Regulatory Updates & Surveillance Summary – September 2020
This regulatory surveillance summary reviews key global regulatory developments from September 2020, including updates affecting healthcare products, regulatory guidance, and compliance expectations. By Laurel Hacche and Debra Cortner, SQA Associates Eudralex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines and Annexes There were no updates noted for Eudralex – Volume 4 – GMP Guidelines […]
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 […]