medicines-medical devices-regulatory affairs
Last updated: 11 May 2023 See updates at the end of the post. In December 2022, I wrote a blog post on the chatbot, ChatGPT. So much has happened since then. There has been an explosion of articles and video…
Date Guidance No About the guidance 14 Feb 2023 MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices – February 2023 This document aims to clarify important terms…
Last updated: 6 February 2023 See updates at the end of the post. Report and minutes from the CMDh meeting held on 13-14 December 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
In 2021, the MHRA held a public consultation seeking views on a legislative proposal to introduce a new regulatory framework for the manufacture and supply of Point of Care (POC) products. This post is about the formal government response to that consultation.…
This post is an attempt to provide a snapshot of the multidistrict litigation (MDL) in the US concerning ranitidine, marketed under the name of Zantac. Most of the information for this post comes from the 341 page ruling1 of December…
Last updated: 27 January 2023 See update(s) at the end of the post. This post is an attempt to provide basic information on CAR-T cell therapy. The information is by no means exhaustive and can be used a starting point…
Title of guidance Type and level of guidance About the guidance Source E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers Final guidance The ICH E2C(R2) IWG has prepared this Q&A document to support implementation of the guidance in practice.…
Last updated: 20 December 2022 See updates at the end of this post. Report and minutes from the CMDh meeting held on 8-10 November 2022 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
Health Canada is consulting on proposed Agile regulations and guidance for licensing drugs and medical devices. It is proposing new targeted provisions and regulatory amendments to the Food and Drug Regulations and Medical Devices Regulations. These changes will continue to…
Guidance No About the guidance MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December…
Last updated: 28 November 2022 See updates at the end of this post. Anonymisation of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) EMA has published the…
Last updated 25 October 2022 See list of updates at the end of the post. Recommendations on submission dates in 2023 for Applications of the MRP This document was produced by the Coordination Group (CMDh) in order to facilitate planning of…