The European Commission’s (EC) long-awaited proposals for reforming pharma legislation have been published. The main thrust of the proposals is to create a single EU market for medicines to replace existing fragmentation and improve access for EU citizens.
The head of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Nathalie Moll, has outlined two urgent actions that European pharma needs as the announcement of the EU’s pharma strategy has been postponed again by the European Commission.
Following the European Commission’s 6 January vote to extend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period, the European Parliament (EP) adopted the proposal on 16 February 2023.
Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the transition period to new rules under the Medical Devices Regulation. The proposal was made at the EPSCO Council meeting on 9 December 2022 by EU health ministers.
The Regulatory Affairs Professionals Society (RAPS) reports that the European Council supports a proposal made by the European Commission to delay the transitional deadlines for medical devices under the MDR.
