The European Medicines Agency (EMA) launched a new initiative Monday called PRIME, which is designed to help expedite the regulatory process for drug makers working on promising medications for rare diseases.
PRIME stands for PRIority MEdicines. Its first phase requires participants submit an application. The agency accepts the submission after reviewing clinical data to see if the medication has the potential to benefit patients with unmet medical needs.
An EMA representative will work with the applicant at an early stage in the process “to provide guidance on overall plans and regulatory strategy,” according to Reuters.
The goal is to help these pharmaceutical firms quickly produce the data needed for accelerated approval. It’s similar to how the U.S. Food and Drug Administration might grant a “breakthrough designation” for a groundbreaking medication for a disease like Alzheimer’s.
The EMA told Reuters it’s expecting about 100 applications per year. You can read the rest of the program’s guidelines here.
Filed Under: Drug Discovery