The data submitted for a Marketing Authorisation (MA) should be of high quality, safety and should be verifiable .

 

In view of a number of critical problems with verification of data available in Marketing Authorisation Application (MAA) dossiers for generic products (bioequivalence/bioavailability studies) a Reflection Paper on Advice to Applicants/Sponsors/CROs of Bioequivalence Studies is developed by the GCP Inspectors Working Group of the EMEA (EMEA/INS/GCP/468975/2007 Reflection Paper on Advice to Applicants/Sponsors/CROs of BE Studies )

 

In view of the Reflection paper and 2010 Guideline on the Investigation of BioequivalenceQAudit  developed (in close cooperation with PCS) a quality vendor program with procedures, query, risk assessment, templates and checklists for Sponsors and applicants to ensure the quality of bioequivalence trials submitted in marketing authorisation dossiers. The quality vendor program can be easily implemented in your quality management system.

 

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