Abstract

COMPREHENSIVE STUDY ON THE REGISTRATION OF GENERIC DRUG PRODUCT IN THE EMERGING MARKET (ASEAN)

Kundara Prerna* and Garg Minakshi

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Abstract

Registration method for generics differs reckoning on country. Association of Southeast Asian Nations area unit the market of interest for several pharmaceutical firms attributable to the enlargement of their trade, improvement of their transportation and communications facilities, and enticing the growth of pharmaceutical market. Medications, being a crucial trade goods should be out there to any or all or any. Drug convenience is a crucial issue within the Association of Southeast Asian Nations region because of country-specific restrictive necessities. Therefore, it's quite difficult for the pharmaceutical firms to urge the drug registered in Association of Southeast Asian Nations member states. It is the key responsibility of everybody department to substantiate the standard, safety, and efficaciousness of a drug product in their country, that has the strategy of regulation, monitoring, producing, distributing, and promoting of the generic medicines. The restrictive framework of health authorities shares similar attributes, however the requirements and procedures for registering generic medicine vary by Association of Southeast Asian Nations member state. One in all the primary challenges for pharmaceutical firms is to form certain that the pharmaceutical merchandise area unit developed as per the restrictive necessities of Association of Southeast Asian Nations member states and to optimize this challenge, assessment of essential parameters throughout development should be done. In Association of Southeast Asian Nations region, documentation is filed in the ACTD format. Though ACTD format is necessary, the member countries have their own necessities for registration method like body documents, and labelling. The aim of this text is to provide the elaborate summary on the restrictive necessities (both general and country- specific) and important problems that occur throughout the registration of drug product in Association of Southeast Asian Nations Member countries.

Keywords: ASEAN, ACTD, Drug registration, Generics.