The US Food and Drug Administration (FDA) on Friday announced the completion of its first collaborative assessment of a post-approval change for an oncology medicine with the European Medicines Agency (EMA) under the auspices of the International Coalition of Medicines Regulatory Authorities’ (ICMRA) joint review pilot program.
The sponsor sought to add new manufacturing and quality control sites, both of which were approved by the US and EU agencies. The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) served as an observer.
The joint assessment teams “had a positive and productive experience, which produced a common set of highly aligned information requests and comments to the applicant,” said Theresa Mullin, associate center director for strategic initiatives in the Center for Drug Evaluation and Research (CDER) and Michael Kopcha, director of CDER’s Office of Pharmaceutical Quality (OPQ)…
