Wednesday , 24 July 2024

Regulatory Strategies for Filing ANDA in European Union

A. Siva Priya*1, K. Uma Sankar2
*1Krishna Teja Pharmacy College, Tirupati, A.P, India
2Head of the Department, Pharmaceutics, Krishna Teja Pharmacy College, Tirupati, A.P, India

A firm or company intended to market their drug products within the European Economic Area should initially get the marketing authorization from a competent authority of a Member State of European Union (EU) or European Economic Area (EEA country) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorisation). The European Economic Area unites the 28 EU member states and the three EEA European Free Trade Association (EFTA) states (Iceland, Liechtenstein and Norway). EEA constitutes total 31 countries, with 26 different languages and 14 types of currencies existing in the region. The total population is about 500 millions. Procedures for application for a marketing authorisation of medicinal product viz. Centralized procedure, National procedure, Mutual recognition procedure and Decentralised procedure, were explained in detail in this article. European Union is the one of major pharmaceutical markets in the world, have different requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. As the CTD consist 5 modules; some modules are common to all regions. The quality, safety and efficacy data has its own importance in the registration dossier. The commercial significance of markets is increasing globally. It is vital for pharmaceutical industry to cope with the regulatory requirements for betterment of public and to ensure their place in the market.
Keywords: Common Technical Document, Marketing Authorization Application, Centralized procedure, Decentralised procedure.

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