Welcome | Date: 18 January 2010
Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval
The EU Risk Management Plans (EU-RMPs) have been a required part of a marketing application for all new chemical entities in the European Union since 2005.
EU-RMPs should describe the safety profile of medications and should propose further pharmacovigilance activities. These activities include a collection of spontaneously reported adverse events and post-authorization safety studies (PASS). In a recent study, researchers found that approximately 40 percent of study proposals for PASS were classified as a short description or a commitment to perform a study without further information, precluding an adequate scientific assessment. Forty-seven PASS were proposed, including 31 for biologicals and 16 for small molecules. Compared with studies proposed in population-based databases, studies in registries were more frequently proposed for biologicals than for small molecules. Approximately 60 percent of the proposed PASS will involve EU residents, the researchers noted. And although no full study protocols were submitted, 26 percent had a limited study protocol, 33 percent had a study synopsis, 37 percent a short description, and 4 percent had a commitment without additional data.
"Evaluation of Post-Authorization Safety Studies in the First Cohort of EU Risk Management Plans at Time of Regulatory Approval"
Drug Safety (12/10) Vol. 32, No. 12, P. 1175; Giezen, Thijs J.; Mantel-Teeuwisse, Aukje K.; Straus, Sabine M.J.M; et al.