Elusive EU Clinical Trial Rules Slip Again -This Time To Late 2018
This article was originally published in SRA
Executive Summary
The schedule for getting the EU's clinical trial portal and database up and running seems to have slipped again, this time by almost a year compared with earlier estimates. As currently forecast, the new system is not likely to be in place, or the provisions of the new Clinical Trial Regulation (CTR) in effect, until the autumn of 2018.
You may also be interested in...
EU Clinical Trials Delayed By Poor Reference Safety Information
EU regulators are increasingly raising objections over the reference safety information that companies include in their clinical trial applications and updated investigator's brochures.
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.