REGULATORY DOSSIERS OF ASEM COUNTRIESAbstract
Demonstration of safety and efficacy of the drug product for human use is important before the drug product gets approval for import or manufacturing of new drug by regulatory authority in any country. Once the clinical and preclinical data have been collected, a New Drug Application (NDA) must be submitted to regulatory authority for approval. Globalization of pharmaceutical industry has created the need to develop the recommendations for development of new pharmaceuticals as well as the regulatory requirement of various countries. Thus, a common format of submission will help in overcoming these difficulties. Through International conference on Harmonization (ICH), Common Technical Document (CTD) guidance’s have been developed for Japan, EU and United States and the Research based industry and more recently its electronic version the electronic Common Technical Document (eCTD). The CTD application format is now favored by USFDA as well as Worldwide regulatory authorities. Implementation of CTD is expected to reduce time and resources needed by the industry to compile applications for global registrations. Asia-Europe Meeting (ASEM) is an informal process of dialogue and cooperation bringing together 27 European Union member states, 2 European countries and the European commission with 20 ASEAN secretariats.
Shravya K.*, Swathi P., Snigdha B., Rastrapal D and Suthakaran R.
Department of Pharmaceutical Management & Regulatory Affairs, Vijaya College of Pharmacy, Munaganoor (V), Hayathnagar (M), Hyderabad-501511, Andhra Pradesh, India
28 February, 2014
08 May, 2014
28 June, 2014
01 August, 2014