medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
This post will be updated on an ad hoc basis. Report from the CMDh meeting held on 12-13 October 2021 Some items of note in this report include the following: CMDh Best Practice Guide on Multilingual Packaging The CMDh has…
Report from the CMDh meeting held on 14-16 September 2021 The report from the above meeting can be viewed here. It includes the following information: Reminder to MAHs for products containing chlorobutanol as an excipient at a level above the…
CMDh Minutes for the meeting on 22-23 June 2021 The minutes for the above meeting are now available here (24 page document) and the following items are included: 1. Brexit (pg 7) The CMDh discussed a topic included under 8.3…
Report from the meeting held on 22-23 June 2021 This meeting reported on a range of topics including the following: Q & A for applicants, MAHs of medicinal products and notified bodies with respect to the implementation of the Medical…
Update from the meeting of interested parties on 19 May 2021 The updates include the following: CMDh Multilingual Packaging Group This concerns an update to the Best Practice guide on Multilingual Packaging (MLP). In the June 2020 version of the…
Last updated on 31 May 2021 Simultaneous National Scientific Advice (SNSA) The EU Innovation Network has been running a pilot for simultaneous national scientific advice from national competent authorities (NCAs) to further strengthen early regulatory support for innovation. The concept of SNSA is to offer…
CMDh Minutes for the meeting on 23-25 March 2021 The minutes from this meeting are available here. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product The updated list is available here. RMS Validation…
List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list updated in March 2021 is available here. Updated Lead Member State PSUR Follow-Up assessment report template This template is available here. Updated List of active…
European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) An implementation plan agreed in February 2021 sets out how the European medicines regulatory network (EMRN), together with the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be implementing…
List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list was updated to Rev 29 in January 20201 and is available here. Clinical Trials Facilitation Group (CTFG) news The CTFG informs Sponsors that the Voluntary…