Generics Firms Advised To Engage Early In Europe's Referral Process
Generic firms are now covered by the pharmacovigilance referral process and participation by their reg affairs staff can help them anticipate, and weigh in on, resulting requirements for additional studies or other measures.
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New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.