Open AccessComparative study of Regulatory requirements of Drug Product in Emerging market
Author(s) -
Jitendra Kumar Badjatya,
Anil Jangid,
Prakash Dodiya,
Saurabh S. Soni,
Akshita Parekh,
Deval Patel,
Jaimin Patel
Publication year - 2022
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v10i1.510
Subject(s) - harmonization , business , product (mathematics) , emerging markets , quality (philosophy) , pharmaceutical industry , premise , standardization , industrial organization , risk analysis (engineering) , finance , medicine , computer science , pharmacology , philosophy , linguistics , physics , geometry , mathematics , epistemology , acoustics , operating system
Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety.
The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.