The EU is looking to liberalize its clinical trial regulations to spur drug development in the Continent, and the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) wants to hear from CROs and drugmakers on the proposed reforms.
The government wants to ensure that new regulations don't overburden CROs foreign and domestic, and it has already reached out to some of India's largest contractors for feedback, PharmaBiz reports. CROs and pharma outfits have until Dec. 31 to file their concerns and opinions to the MHRA.
Among the proposed regulatory changes is a centralized application process for multicountry trials, sparing researchers from getting approval from each country involved in a study. The EU is also considering instituting a risk-based regulation system, creating a sliding scale of red tape for trials depending on how risky they are. Under current law, trials of already-approved treatments go through the same hurdles as those of in-development drugs, slowing down the process and, experts say, scaring off CROs and drug developers.
Furthermore--and perhaps most important--the proposed changes would force member states to comply with the rules. As it stands, EU countries can adopt the body's clinical trial regulations as they see fit. The new rules could save about $350 million in administrative costs, the EU estimates, and bring down compliance costs by around $519 million, PharmaBiz reports.
The proposal has been widely lauded in the CRO world, with numerous global research companies lending their support to the idea and ACRO praising the EU for moving in the right direction.
- read the PharmaBiz report