EMA, FDA collaborate on medicines safety
This cluster will involve monthly meetings via teleconference, during which agency representatives will discuss “areas that have been identified as requiring an intensified exchange of information and collaboration.”
Representatives from the regulatory bodies of Canada and Japan will participate in these meetings as observers.
In a joint statement, the EMA and FDA said, “This increased degree of interaction will allow the agencies to work swiftly in the area of the safety of medicines and to coordinate communication activities.”
The development follows heightened efforts in medicines safety from the EMA, centered around the launch of new pharmacovigilance legislation in 2012.
These rules include new powers for the EMA, allowing the agency to ask for post-marketing safety and efficacy studies, and the creation of a Pharmacovigilance Risk Assessment Committee (PRAC) to recommend on drug safety issues in the E.U.
In the 18 months since it launched, the PRAC has made safety recommendations on Ariad's cancer drug Iclusig (ponatinib) and Bayer's contraceptive Diane 35 (cyproterone acetate) among others.
The new cluster builds on these efforts, and the EMA and FDA have experience in similar arrangements for other issues, including biosimilars, orphan drugs and pediatric medicines.
EMA's executive director Guido Rasi explained more collaborative regulatory relationships were needed due to the increasingly globalised nature of the pharma industry.
“Medicines' regulators are inter-dependent: any action taken in one territory has repercussions on the rest of the world,” said Rasi. “International cooperation is a key area of work for the Agency.”