Post approval changes are changes to any characteristic of pharmaceutical product after approval. Certificate of suitability of European pharmacopoeia (CEP) and drug master file (DMF) are two mechanisms for active pharmaceutical ingredient (API) registration. Regulatory requirements vary for each mechanism. This study focused on regulatory requirements for post approval API source change in the European Union (EU) and USA; and to delve on the mechanism of post approval API source changes in the USA and EU. To improve quality of the API, the most of the pharmaceutical industries concentrate on CEP certified source instead of DMF as CEP assures compliance to standard and compliance to good manufacturing practices as well. DMF to CEP source change is considered as minor change as it provides more assurance toward standard and quality whereas CEP to DMF source change is considered as major change because of no assurance of standard compliance in both countries. Differences observed by this study include approval procedure, timeline and fees for approval; similarities are observed classification of variation but the terms used for each class differ. In both the countries, CEP is preferred over DMF to improve quality of the product and to assure its safety.
Faculty of Pharmaceutical Sciences, Chulalongkorn University
Kamnoore, Kalpana; Venkatesh, M. P.; and Kumar, T.M. Pramod
"Study on post approval source change
of active pharmaceutical ingredient in
the finished product and its regulatory
requirements in EU and US,"
The Thai Journal of Pharmaceutical Sciences: Vol. 46:
1, Article 2.
Available at: https://digital.car.chula.ac.th/tjps/vol46/iss1/2