Three countries in Association of Southeast Asian Nations (ASEAN) region i.e. Thailand, Malaysia, and Singapore have made many significant attempts towards harmonization of regulatory practices. One example of this harmonization is adoption of ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR). Even after these efforts longer review durations for generic application and frequent rejections are still there. These delays or rejections in generic dossier not only impact market access for companies but also prevent timely access to essential medicines for patients, which has a directly impact on public health.
This article undertakes systematically analysis of the regulatory frameworks across three countries, to identify common reasons for dossier rejections, such as incomplete submissions, non-adherence to global or nationalized regulatory requirements, and quality-related deficiencies. Additionally, this review examines factors which contributes to delay in approval and country-specific regulatory hurdles. The findings indicates that Singapore is a leader in digital advancement and offers streamlined regulatory pathways; however, its stringent requirements can sometime act as barriers in approval. Conversely, other two countries i.e. Thailand and Malaysia continue to face its regulatory procedural bottlenecks.
The findings indicated toward the urgent need for harmonization of standards, scope for digitalization of information, use of electronic submission platforms to save time and use of artificial intelligence (AI), adopting regulatory practices and requirement as laid down by internation regulatory bodies like International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) and World Health Organization (WHO), strengthening joint assessment initiatives and enhancing cross-country collaboration between authorities. Utilizing mutual recognition and joint assessments of dossiers and providing regular training, on current expectation, to industry would also help in ensuring timely, accurate submissions and in turn faster approvals. By addressing these points, these three countries can improve their regulatory efficiency, reduce delay in approval, and provide faster access to high-quality medicines for their people.
Keywords: ASEAN, ACTD, dossiers, Thailand, Malaysia, Singapore, rejection, delays, regulatory harmonization, ICH, health impact.
How to cite this article: Sharma M, Jyotsna, Kumar J, From Submission To Approval: Unpacking Regulatory Dossier Rejections And Delays In Asean: A Review. Int J Drug Deliv Technol. 2026;16(2s): 542-556; DOI: 10.25258/ijddt.16.542-556