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, […]
SQA Regulatory Surveillance Summary | December 2020 –
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 Commission has issued a new technical document agreed by national authorities and stakeholders that further clarifies which claims producers of cosmetic […]
SQA Regulatory Surveillance Summary | November 2020 – copy
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), detailing guidelines for the implementation of remote control for many critical medical devices. Notably, the U.S. Food and Drug Administration (FDA) has […]
SQA Regulatory Surveillance Summary | October 2020
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 will be Stricter with the Cancellation of Good Manufacturing Practice (GMP) Certification in China, CPhI & P-MEC China, 26 October 2020 The Amendment […]
SQA Regulatory Surveillance Summary | September 2020
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 and Annexes for September 2020. https://ec.europa.eu/health/documents/eudralex/vol-4_en European Federation for Cosmetic Ingredients (EFfCI) There were no updates noted for EFfCI for September 2020. […]
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
By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 July 2020 The Committee for Medicinal Products for Human Use (CHMP) of the EMA published a final assessment report on nitrosamine impurities on 25 June 2020. The report calls on […]
SQA Regulatory Surveillance Summary | June 2020
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 series of guidances (a total of four) intended to facilitate the advancement and use of systematic approaches to collect and use robust and […]
Regulatory Surveillance Summary | May 2020
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 to a global search for therapies to treat, diagnose, mitigate, or prevent the infection. Before new therapies can be made available […]
Regulatory Surveillance Summary | April 2020
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Biological Product Deviation Reporting for Blood and Plasma Establishments, March 2020 The US FDA has provided blood or plasma establishments with revised recommendations related to biological product deviation (BPD) reporting. The guidance document is intended to assist blood […]