• K Sai Bharadwaj
• Adilakshmi. Ch
• M.V.Nagabhushanam
• Sk.Sanjuda
• G.Rama Krishna

The work is focused on demonstrating the current scenario of global countries for approval of generic products. The regulatory framework and ASEAN countries, providing an overview of critical regulations as well as procedures that need to be followed in each country. It Provides post-approval submission in USA, illustrating industrial practices with regards to post-approval management procedure and it includes information regarding post-approval submission within EU and its implications across various categories of variation procedure. The regulatory submissions required for Australia along with general requirements which are applicable here while compares bridging approaches between Australia, Canada, Europe, Russia and ASEAN countries using relevant case studies from industry level so that common development can be achieved at cost effective rates by developing appropriate strategies accordingly. The development of a common drug product that can be filed across the globe is an important step in modern medicine. This process requires collaboration between countries and regulatory bodies to ensure that each country's regulations are taken into account when developing the product. A comprehensive regulatory strategy must also be developed to guide this process, ensuring timely launch of products while meeting existing regulations. The pharmaceutical industry is facing a period of rapid change and evolution, with new regulations being implemented in both the European Union (EU) and United States (US).Understanding what requirements exist across different countries will help provide companies with greater flexibility moving forward, allowing them access larger markets which could ultimately lead higher profits over time. Therefore, by reading these four pieces combined together one can gain an invaluable knowledge base regarding current trends within pharma industry today.One challenge in developing a global drug product is understanding the different requirements for each country’s regulation system, as well as how these systems interact with one another. To overcome this challenge, it is necessary to draft regulatory strategy which outline what needs to be included when submitting a regulatory submission for approval within any given country or region. Additionally, they should include information about potential differences between local laws governing safety and efficacy standards so companies know exactly what needs to be done before launching their products globally. Furthermore, establishing clear timelines help to submit pre-submission and post submission in timely manner across the global market. Ultimately, successful implementation of these strategies will enable companies and governments alike achieve their goals regarding international drug approvals faster than ever before.

ASIAN Countries, Post approval Submissions, Post Approval Managemment, Pharmaceutical Industries

"COMPARISON STUDY OF REGULATORY APPROACHES OF SOME ASIAN COUNTRIES FOR APPROVED FOR GENERIC PRODUCTS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 10, page no.d708-d718, October-2025, Available :http://www.jetir.org/papers/JETIR2510392.pdf

"COMPARISON STUDY OF REGULATORY APPROACHES OF SOME ASIAN COUNTRIES FOR APPROVED FOR GENERIC PRODUCTS", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 10, page no. ppd708-d718, October-2025, Available at : http://www.jetir.org/papers/JETIR2510392.pdf