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@article{185617,
        author = {M SNEHA KALYANI and M.V .Nagabhushanam and Adilakshmi.Ch and Sk.Sanjuda},
        title = {REGULATORY REQUIREMENTS OF EU POST APPROVAL PROCEDURES OF AUSTRILA},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {5},
        pages = {2663-2671},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=185617},
        abstract = {The main goal of the work is to illustrate the present situation of generic product approval in various nations throughout the world. The ASEAN nations and regulatory framework, which give a summary of important laws and protocols that must be adhered to in each nation. Information about post-approval submission in the EU and its implications across several categories of variation method is included, along with examples of industrial practices involving post-approval management procedure and post-approval submission in the USA. In order to compare bridging approaches between Australia, Canada, Europe, Russia, and ASEAN countries using pertinent case studies from the industry level, the regulatory submissions required for Australia are combined with general requirements that apply here. This allows for the development of appropriate strategies that will enable common development to be achieved at cost-effective rates. A significant advancement in contemporary medicine is the creation of a generic medication that can be sold anywhere in the world. Countries and regulatory agencies must work together during this process to make sure that each nation's laws are considered when creating the product. To ensure that products are launched on time and in compliance with current rules, a thorough regulatory strategy must also be created to direct this process. With new rules being put into place in the US and the EU, the pharmaceutical business is going through a time of tremendous transformation and change. Companies will have more freedom going ahead if they are aware of the criteria in other nations. This will enable them to reach broader markets, which may eventually result in higher earnings. As a result, reading these four articles together can provide a wealth of information about the current trends in the pharmaceutical sector. Understanding the various needs for each nation's regulatory system and how these systems interact with one another is one of the challenges in creating a global pharma product.},
        keywords = {ASEAN Nations, post-approval submission in the EU, post-approval submission in the USA},
        month = {October},
        }