Abstract

SCIENTIFIC INFORMATION REQUIRED FOR GRANTING THE MARKETING AUTHORIZATION FOR VARIOUS DOSAGE FORMS IN EUROPE BY EMA/EU NATIONAL COMPETENT AUTHORITY

T. Gnana Prathyusha*, Dr. M. V. Nagabhushanam and Sana Khan

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Abstract

The scientific information required for granting the Marketing authorization for various dosage forms in Europe by EMA/EU National competent authority explains about the detailed note on the development of novel drug, including discovery, non toxicology studies, initial clinical trials, and pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is health authority review of marketing authorization application. It mainly explains the process and the usage of marketing authorization process. The review by regulatory authorities is to evaluate whether the data supports a positive benefit/risk profile takes many months, adding additional time before patients may access therapy. In this article we discuss the various opportunities in the European medical agency (EMA) offer to expedite the drug development and regulatory approval timelines for drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.

Keywords: European medical agency (EMA), European Union (EU), Marketing authorization.