A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

 

Drug Profile [24-35]

*As of May 2015

Conclusion
From the study it could be understood that getting a market authorization for registration of a drug in any territory requires a particular format, and that each country follows a specific guideline in addition to its own regulations which are laid down by the respective drug regulatory authority. There are basically two formats available in most of the countries of world one is , ICH-CTD and the other is ACTD. ICH-CTD is followed by ICH countries where as ACTD is usually adopted by ASEAN countries.  The ICH-CTD has five modules, in which module 1 is country specific presenting administrative information of the country but the other four modules which are framed for drugs. They include descriptive scientific details information and are common to all the countries which follow the format. Module - 2,3,4,5 have summary of quality, nonclinical and clinical information, respectively. The ACTD has parts instead of module. They are four in number. These include summary of quality, nonclinical and clinical in part II, III, IV, respectively.

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