Abstract

REGULATORY REQUIREMENTS FOR THE REGISTRATION OF GENERIC DRUGS IN EUROPEAN UNION (EU)

Tanniru Siva Pavani*, G. Ramakrishna, M.V. Nagabhushanam, Rompicharla Sushma, Malinedi Gowthami, Adil Akshmi Challa, S.K. Sanjuda, M. Beena Devi

ABSTRACT

The present study describes the process of regulatory submission and generic drug registration in Europe. The information and data for the compilation of the present review has been obtained from the relevant journals and from the official websites of respective drug regulatory authorities of Europe. The generic drug approval process differs from one country to another. Europe follows multiple registration processes and the applicant decides the pathway based on the product category while the other three countries stick to a single registration process. All four countries follow the electronic CTD format for submitting the regulatory documents which allows the evaluation process more convenient and easier. The British Pharmacopoeia is a single reference guide for the quality control of medicines in all four countries under this study. From this study, it was concluded that in Europe it takes about 12 months for dossier review for the approval of the generic drug.

Keywords: Generic Drug, Abbreviated New Drug Application (ANDA), European Medicines Agency (EMA) guidelines.