medicines-medical devices-regulatory affairs
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…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published Version 1.0 of the recommendation paper on decentralised elements in clinical trials . The 33 page document was adopted by the Accelerate Clinical Trials in…
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…
This post is an attempt to provide basic information on the Swissmedic Marketing Authorisation for Global Health Products (MAGHP) and the MAGHP Light procedures. The MAGHP and MAGHP Light Procedures are part of Swissmedic’s engagement in development cooperation, in accordance…
Title of guidance Type and level of guidance About the guidance Source Providing Over-the-Counter Monograph Submissions in Electronic Format Draft This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act) (21 U.S.C. 355h)…
Last updated: 21 September 2022 See list of updates at the end of the post. Report and minutes from the CMDh meeting held on 19-20 July 2022 The CMDh minutes are a full record of the CMDh meetings (minus redaction…
Guidance No About the guidance MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6)…