Pharma Taken By EU Pilot On Merging MRP/DCP Lines
This article was originally published in SRA
Executive Summary
Drug companies have shown a huge interest in part of an EU pilot project that allows them to merge licences under the mutual recognition and decentralized procedures to suit their business strategies1,2. Generic and OTC drug makers submitted over 60 applications for merging their MRP/DCP lines, of which 10 have been admitted in accordance with the maximum permissible limit of the pilot.
You may also be interested in...
EU Extends Pilot On Splitting Mutual Recognition/Decentralized Procedures
Drug companies in the EU are getting more time to experiment with splitting their mutual recognition and decentralized procedure licences to help with their marketing strategies.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.