Category CMDh updates

CMDh updates – September 2021

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 updates August 2021

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…

CMDh updates July 2021

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…

CMDh updates June 2021

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…

CMDh updates May 2021

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 updates April 2021

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…

CMDh updates March 2021

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…

CMDh updates Feb 2021

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…

CMDh updates January 2021

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…