Gap Analysis on ASMF/DMF frameworks and procedures


- J Pharm Pharm Sci. 2016 Apr-Jun; 19(2):290-300

By Pharmaceuticals and Medical Devices Agency(PMDA), Japan– 5  August  2016

The PMDA, on behalf of the IGDRP, investigated and have published a Gap Analysis on the ASMF/DMF frameworks and procedures of IGDRP members.  This paper has been published in the Journal of Pharmacy and Pharmaceutical Science entitled: Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.