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Meghana Peddi*, M. V. Nagabhushanam, D. Nagarjuna Reddy, Brahmaiah Bonthagarala and G. Ramakrishna


The aim of this document is to examine methodological challenges by comparing generic drug registration and regulatory requirements in European countries. European countries are fast growing and emerging markets in pharmaceutical sector. Increasing patent expirations and the need for less expensive drugs is fuelling the growth of generics market in the region. However, there are some challenges to be met in order to sustain the growth. Hence the objective of present study is to analyse overall aspects like the requirements for registration of generics in the following 28 “EMA” (European medicines agency) countries, Drug registration procedure for the approval of generic drug in these countries, Mark out the differences in the requirements to register generic drug product in these countries. The primary purpose of the rules governing generic drugs in Europe is to safeguard to public health. It is the role of public regulatory authorities to ensure that pharmaceutical companies comply with regulations. There are legislations that require drugs to be developed, tested, trailed, and manufactured in accordance to the guidelines so that they are safe and patient’s well - being is protected. The regulatory submissions in the EU, in the world continue to have significant differences. When compared to others the EU approval process is typical and contain more data to be summarized for the dossier submission.

Keywords: Generic drug registration, Regulatory requirements, European medicines agency (EMA), European countries.

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