Abstract

DMF PREPARATIONS, REQUIREMENTS FOR MARKETING AUTHORIZATION AND PROCESS OF API IN EUROPEAN UNION

Y. Ratna Sindhu*, N. Sudarshini, Brahmaiah Bonthagarala, M. V. Nagabhushanam, G. Ramakrishna

ABSTRACT

The DMF preparation is most important to know exactly the pharmaceutical ingredient legislations (name, purity, intended use, adverse drug reactions). To submit a marketing authorization application (MAA) in all countries, it is important to know exactly the pharmaceutical legislations (regulations, directives and guidelines) and the regulatory requirements in each country in advance. For registration of drug products we need to know about the requirements for the registration of active pharmaceutical ingredients (API) which is the part of drug product and influences the quality of drug product. Due to the fact that the European Union (EU) and the United States (US) are the biggest and most potential markets for medicinal products in the world. Therefore within this dissertation a scientific requirement and recommendation for the registration of an active pharmaceutical ingredient is provided within these regulatory regions. The different pharmaceutical legislations and regulatory requirements for a new MAA of an API of EU are discussed and analyzed in detail. The analyses are made especially concerning the aspects required for marketing authorization and accepted dossier requirements for the registration of API in the EU.

Keywords: MAA, API, DMF, ASMF, FDA, EMEA.