End Of Road For ‘Too Complex’ EU Pilot On Splitting Marketing Licenses
Executive Summary
EU regulators have pulled the plug on a pilot program on splitting mutual recognition and decentralized procedure licences. Instead of promoting harmonization of marketing authorizations across the EU and helping companies with their marketing strategies, it has led to more problems.
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.
EU To Test Merging & Splitting Of Licences Under Mutual Recognition/Decentralized Procedures
The CMDh - the EU group that co-ordinates the approval of human medicines evaluated through the mutual recognition and decentralized procedures - has launched a pilot project that will allow drug companies to merge or split MRP/DCP lines to suit their business strategies1.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.