Adaptive Pathways: Earlier Access, But What About Data Exclusivity And SPCs?
This article was originally published in SRA
Executive Summary
The European Medicines Agency said recently that its adaptive pathways project had been successful in helping to facilitate the development and approval of new drugs via iterative evidence gathering, and that it was planning to incorporate the lessons learned from the pilot into the mainstream drug development process1.
You may also be interested in...
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.
UK Explains New Rules On Parallel Imports From EU
Guidance from the Medicines and Healthcare products Regulatory Agency says that the packaging of parallel imported medicines must make clear that they are for the UK market only.