Regulatory Surveillance Summary | February, 2020
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, Draft Guidance, January 2020, Revision 2 This guidance revises the draft guidance Current Good Manufacturing Practice – Interim Guidance […]
Regulatory Surveillance Summary | January, 2020
By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations/Guidances Regulation of Vaping Products in Canada, December 2019 On 19 December 2019, Health Canada announced the final “Vaping Products Labelling and Packaging Regulations,” creating new labeling and packaging requirements for vaping products to increase awareness of the health hazards of using vaping products, help prevent the […]
Regulatory Surveillance Summary | December, 2019
By Laurel Hacche, SQA Associate SQA Regulatory Surveillance Summary for Q3-Q4, 2019 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 guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature. […]
Regulatory Surveillance Summary/EU MDR – October 2019
By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will go into effect. All Medical Devices manufactured and/or sold in the European Union will be affected by this new regulation. Whether it’s a “simple” syringe or a “complex” insulin pump system with Bluetooth connection […]
Regulatory Surveillance Summary July 2019
SQA Regulatory Surveillance Summary for Q2, 2019 International Council for Harmonization (ICH) Guidance ICH Harmonized Guideline, Optimization of Safety Data Collection, E19, Draft April 2019 This Guideline is intended to provide internationally harmonized guidance on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a […]
Regulatory Surveillance Summary March 2019
Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an amputation, devices that can bridge the gap between the brain and computers—called brain–computer interfaces (BCIs)—hold great promise. These devices can be implanted into the nervous […]
Regulatory Surveillance Summary Winter 2018
European Federation for Cosmetic Ingredients (EFfCI) No updates noted for EFfCI Good Manufacturing Practice Working Group. Click here for more information European Medicines Agency (EMA) Regulatory Science to 2025 – Launch of Six-Month Public Consultation, 19 December 2018 EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation . This is […]
Regulatory Surveillance Summary for August 2018
China GMP WHO Statement on Rabies Vaccine Incident in China: 25 July 2018 The World Health Organization (WHO) fully supports the China National Drug Administration’s (CNDA’s) actions to withhold problematic batches of rabies vaccine and ensure they are not placed on the market. During an unannounced inspection at the manufacturing site of Changchun Changsheng Life […]
Regulatory Surveillance Summary for July 2018
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review […]
Regulatory Surveillance Summary for June 2018
European Federation for Cosmetic Ingredients (EFfCI) European Federation for Cosmetic Ingredients (EFfCI) Good Manufacturing Practice (GMP) for Cosmetic Ingredients, Revision 2017 This document incorporates existing GMP principles, World Health Organization (WHO) GMP Guidelines for Excipients, International Pharmaceutical Excipients Council (IPEC) GMP for Bulk Pharmaceutical Ingredients 2006, and International Quality Management System requirements as developed […]