Certificate of Suitability

Certificate of Suitability. A certificate issued by a regulatory body charged with review of NDAs in any country or jurisdiction to confirm the marketing authorization status of products authorized by the regulatory body. By way of example, in the EU, the Committee for Medicinal Products for Human Use issues European Medicines Agency Certificates of Medicinal Products on behalf of the European Commission to confirm the marketing status of NDAs in the EU. The purpose of a Certificate of Suitability is to facilitate or gain... approval in other countries with limited or no independent formal regulatory review. View More