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… read more →
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… read more →
Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an… read more →
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… read more →
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… read more →
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… read more →
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… read more →
European Federation for Cosmetic Ingredients (EFfCI) No updates noted as of 09 March 2017 European Medicines Agency (EMA) Guideline on the Chemistry of Active Substances, 15 November 2016, EMA/454576/2016 The… read more →
You may be in the process of upgrading your Quality Management System to the new ISO 9001:2015 requirements, but don’t forget that there are new changes to the ISO 13485… read more →