he Association of Southeast Asian Nations (ASEAN) Joint Assessment (ASEAN JA) is a collaborative procedure that is open to all 10 ASEAN National Regulatory Authorities (NRAs) on a voluntary basis. The ASEAN JA framework, which was developed by the ASEAN Joint Assessment Coordinating Group (JACG), started with a pilot joint assessment product in July 2017 with support and technical advice from the World Health Organization (WHO). Our experience with ASEAN JA shows that it is a promising pathway which fosters cooperation and harmonization within the region while making the best use of available resources and reducing duplication of work. The procedure was more efficient when compared to the national standard pathways; however, it took longer than the NRAs’ national facilitated or reliance pathways; as a result, improvement is still needed to incentivize the use of this pathway.
Under this regulatory procedure, the same application is simultaneously submitted to all participating ASEAN NRAs*. Assessment work is then carried out jointly by all participating NRAs and a joint assessment report is issued at the completion of the procedure. This is followed by the national registration step at the country level, maintaining the NRAs’ sovereignty for final regulatory decision making.
Historically, the ASEAN JA procedure was not widely used, as the scope of therapeutic products was by design limited to medicines for treatment of priority diseases in the ASEAN region such as malaria, tuberculosis, etc. By 2022, the list of priority product categories eligible for the ASEAN JA was expanded to include more disease areas such as autoimmune diseases and oncology. In addition, applicants can propose other products outside the priority areas for consideration by ASEAN NRAs if the products have already been approved by a reference NRA. The ASEAN JA defines reference NRAs as WHO “stringent” NRAs or WHO-Listed Authorities which issue unedited assessment reports in English.
Prior to the pilot, three products were reviewed using this pathway which were all chemical entities. The concept of using the ASEAN JA procedure for a biological product was the subject of a pilot program in which a multinational company embarked in partnership with WHO and NRAs of ASEAN Member States (AMS). The aim was to leverage ASEAN JA to bring reliance into action and realize the benefits of the collaborative procedure in the following aspects:
- Improve efficiency of the registration process by shortening the approval time
- Avoid duplication of work through a collaborative joint assessment mechanism
- Promote harmonization by reducing or waiving country requirements.
Additionally, this partnership can enhance trust among NRAs, WHO, and industry by working closely and jointly optimizing the operational aspects of the pathway.
Selection of Candidate Product and Participating NRAs
The candidate product proposed by the company fulfilled the product selection criteria—the product is used for the treatment of an autoimmune disease and has received approval from several Reference NRAs including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Australian Therapeutic Goods Administration (TGA). The sponsor leveraged EMA and TGA as the reference agencies in the reliance approach by submitting the approval letter, unredacted assessment report, and list of questions and answers (Q&As) from EMA, as well as TGA’s assessment report.
The NRAs from Malaysia (lead), Indonesia, Philippines, Thailand, Cambodia, and Laos participated in the pilot.
Participation of the ASEAN NRAs is voluntary and the sponsor must be ready to submit the application to all NRAs who wish to participate; it was not possible for the sponsor to select the NRAs in this pilot. There is a strong focus on strengthening the regulatory capabilities of AMS by providing opportunities for capacity building and training in regulatory science, as well as facilitating equitable access to the priority medical products for their populations. At the time of the pilot in Q4 2022, the ASEAN JA procedure did not allow the sponsor to tailor their filing plan according to considerations on the disparity of disease prevalence or medical needs among AMS.
Procedural Steps and Milestones
The AJA procedure follows a structured approach starting from the company’s submission of an Expression of Interest (EOI). The diagram above provides a general overview and the timeframe of the key steps. A dedicated IT platform from WHO called the Joint Assessment Information Management System (JAIMS) was used for submission of the dossier and all formal correspondence related to the review.
Key Takeaways from the Pilot
Efficiency of Review and Approval
From the start of technical assessment or the formal review, the joint assessment procedure took approximately 6 months (175 days) excluding the stop clock for Q&As, and it is slightly longer than the published timeline for the AJA process of 140-150 days.
Including the final national registration step, the overall approval process ranged from 7 months to 9.5 months. The difference observed was solely due to the duration for approval by the individual NRAs. See table below for a comparison of the timeline (shown as Working Days, WD) for regulatory decision making at the country level. Additional administrative processes in the country after regulatory decisions led to longer approval timelines in some countries. As a result of the learnings from this pilot, improvements have been made to several local administrative processes such as the issuance of electronic approval and the use of eSignature in Thailand. Cambodia and Laos did not proceed with the country registration, as there is no legal entity representing the multinational company in these countries.
The diagram below shows the comparison of AJA with the national registration pathways. In this pilot, the AJA procedure is shorter when compared to the national standard pathways, but longer than the national facilitated or reliance pathways, except for Thailand.
Consistency, predictability, and efficiency of approval in comparison to the national pathways is a key expectation for ASEAN JA to be viable.
Number of Review Questions
From the joint review, one consolidated set of queries consisting of 14 questions was issued. Seven additional questions were raised by the individual NRAs. Overall, the number of questions received was fewer than expected in comparison to individual national filings, reflecting a minimization in duplication of efforts and saving of company resources.
Harmonization of Regulatory Requirements
The dossier submitted was the same as that approved by EMA, and any differences in the dossier were listed out for transparency and to provide assurance of product sameness. In addition, the sponsor was expected to comply with the local country-specific mandatory requirements. However, in this pilot, a couple of local requirements such as biologics registration testing for Thailand and analytical method protocol and raw data for Malaysia were waived. This suggests greater dossier harmonization and alignment of the country’s requirements with international standards is achievable.
The successful outcome of this pilot demonstrated the feasibility of utilizing ASEAN JA for all classes of therapeutics, including complex biologics.
What’s Next?
The multinational company is now partnering with WHO and ASEAN NRAs to explore other pilots using ASEAN JA, with a vision to expand it to become a standard end-to-end pathway for lifecycle management of a medicine. Through steady improvement and accumulated experience, we hope that ASEAN JA’s attractiveness as a regulatory pathway will grow and achieve its objective of ensuring faster access to good-quality, effective medicines for all ASEAN citizens. The outcomes of the second pilot are expected to be published in 2026.
To learn more about this topic, plan to attend DIA’s Singapore Annual Meeting 2025: Charting the Future: Navigating the Evolving Healthcare Landscape and Trends in Asia or DIA’s Asia Meeting 2025: The Future of Health in APAC: Integrating Clinical Trials into Clinical Practice.