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Journal: Indo American Journal of Pharmaceutical Sciences (IAJPS) (Vol.3, No. 1)

Publication Date:

Authors : ; ; ; ; ;

Page : 5-17

Keywords : EU ? European Union; EMA ? European Medical Agency; EEA - European Economic Area.;

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In this retrospective study which deals about the rules & regulations which are required for drug approval process in Europe. Developing a new drug requires great amount of research work in pharmaceutical sciences and pharmacological basics. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This retrospective provides clear information on list of EU member countries, EEA, EFTA, and EMA. Different types of submission procedure for regulatory approvals were explained clearly. The European Medicines Agency is responsible for the centralized authorization procedure for human and veterinary medicines. This procedure results in a single marketing authorization that is valid in all EU countries, as well as in the European Economic Area (EEA) countries. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. Key Words: EU ? European Union, EMA ? European Medical Agency, EEA - European Economic Area.

Last modified: 2016-02-14 15:27:05