Asia-Pacific drug regulators urged to cut duplicate reviews and speed patient access

Regulatory reliance pathways, which let national drug regulators lean on the assessments of trusted foreign authorities instead of repeating full scientific reviews, are spreading across the Asia-Pacific region. Yet according to a new survey from the Asia Partnership Conference of Pharmaceutical Associations, or APAC, the promised efficiency gains are being eroded in practice by persistent local requirements, demands for confidential documents and uneven adherence to published review timelines. The study, published in AAPS Open, assessed how reliance pathways described in official guidelines actually perform in the day-to-day experience of the pharmaceutical industry across 12 economies.

APAC, an industry-driven platform of research-based pharmaceutical associations across Asia Pacific, distributed a structured questionnaire to all 14 of its member associations, with responses consolidated into one valid answer per economy. The survey covered reliance pathways for three submission types: new drug applications, new indications and post-approval changes. Data collection was completed by February 2026 and reflected the regulatory status of national authorities in the 12 economies up to December 2025. Where more than one member association existed in a single economy, responses were merged to reflect a unified industry perspective.

The findings document a region in transition. In 2025, Malaysia’s National Pharmaceutical Regulatory Agency removed the Certificate of Pharmaceutical Product requirement under its facilitated registration pathway and extended reliance to new indications and post-approval changes. Vietnam formally established a reliance pathway for new drug applications in the same year. Since 2021, additional economies have dropped the certificate requirement for specific pathways and broadened reliance across submission types. When asked which reference authorities they used most, member associations ranked the European Medicines Agency first, cited by all respondents, followed by the US Food and Drug Administration at 83 percent, then Australia’s Therapeutic Goods Administration and Japan’s Pharmaceuticals and Medical Devices Agency, each at 42 percent, and the UK Medicines and Healthcare products Regulatory Agency at 8 percent.

Reliance operates through two main models. In an abbreviated pathway, the national regulator conducts a simplified assessment that builds on the prior evaluation by a reference authority and concentrates on unresolved or locally relevant issues. A verification pathway goes further, mainly confirming that the product, the submitted dataset and the regulatory decisions align with those of the reference authority, with minimal additional scientific assessment. The World Health Organization’s definition of regulatory reliance, set out in its technical report series, emphasizes that the national authority gives significant weight to another trusted authority’s assessment while retaining responsibility for its own decision.

Operational experience told a more complicated story. Member associations from China, India, Japan and South Korea were excluded from the operational analysis because their economies lack a local reliance pathway, leaving responses from eight economies: Indonesia, Singapore, Thailand, Malaysia, the Philippines, Vietnam, Taiwan and Hong Kong. Half of the reporting economies said reliance submissions added up to 30 percent more workload than standard submissions, and only Indonesia reported no additional workload. In Hong Kong, the standard pathway was reported as not applicable because reliance is already part of the routine regulatory framework. For new drug applications, the most frequently reported barriers were persistent local-specific requirements such as certificate submissions, single-site or one-license rules and import re-testing, along with requests for unredacted non-public assessment reports and documentation beyond published reliance criteria, including interim reports, question-and-answer records and inspection reports.

Post-approval changes faced similar friction. Across seven member associations, 57 percent identified requests outside reliance guidelines and demands for unredacted non-public assessment reports as key implementation challenges. Respondents also cited variability in how variations are categorized across jurisdictions, limited acceptance of approval letters as standalone evidence of approval, and procedural restrictions on bundling reliance and non-reliance variations within a single application. The most frequently requested additional documents outside published eligibility criteria were lists of outstanding issues and questions issued by the reference authority, followed by chemistry, manufacturing and control documentation, administrative documents, interim or rapporteur’s assessment reports, and package inserts or GMP clearance papers.

The efficiency question yielded mixed results. Most participating economies reported reductions in regulatory questions after adopting reliance pathways for new drug applications, though the magnitude varied, and similar trends appeared for new indications while effects for post-approval changes were positive but more variable. Vietnam reported no experience because its pathway was only implemented in 2025. Timeline performance was less consistent: Malaysia and Singapore consistently met published timelines, whereas several other economies reported delays ranging from one month to as long as twelve months. The authors conclude that while reliance may reduce the volume of regulatory queries, improvements in review timelines depend on broader procedural factors and operational capacity within national regulatory systems.

The survey’s central recommendation is that abbreviated reliance pathways should primarily leverage publicly available assessment reports and approval letters, focusing national reviews on unresolved or locally relevant issues rather than repeating assessments already conducted by reference authorities. The report argues that requiring unredacted non-public assessment reports in abbreviated pathways creates a structural mismatch, allowing reliance to function in name while operating as a full independent review in practice. Supplementary documents such as interim reports and question-and-answer records should be exempted, the report says, because they are non-core and may duplicate information already contained in the assessment report. For verification pathways where confidential reports are genuinely needed but hard to obtain, particularly from the US FDA, the report suggests pragmatic acceptance of alternative evidence, such as a public assessment report supplemented by targeted questions on the chemistry, manufacturing and control section.

Looking ahead, 83 percent of member associations, ten out of twelve economies excluding China and Japan, indicated plans to engage national regulatory authorities on good reliance practices in 2026. Priorities include limiting national assessments in abbreviated reviews to locally relevant issues using the public assessment report as the main scientific basis, strengthening verification pathways, expanding reliance to post-approval changes and new indications in Vietnam, Taiwan, Thailand and India, and advancing electronic Common Technical Document implementation to facilitate information sharing. Member associations also urged removal of local-specific requirements not aligned with WHO Good Reliance Practices, particularly local clinical trial requirements, since reliance should not require additional local studies beyond the assessment already conducted by the reference authority. In India, where the Central Drugs Standard Control Organisation has applied reliance on a case-by-case basis through Rule 101 for certain biological products, APAC recommends expanding the scope to all products and removing local clinical trial requirements where reliance is applied.

The report also points to collaborative mechanisms as a complement to unilateral reliance, citing the ASEAN Joint Assessment, the ACCESS consortium linking Australia, Canada, Singapore, Switzerland and the United Kingdom, the European Medicines Agency’s OPEN framework, and pilot programs led by the International Coalition of Medicines Regulatory Authorities, including the Collaborative Hybrid Inspection Pilot for inspections. It notes that regulators in Singapore, South Korea, Japan, Australia and Indonesia are now recognized as WHO Listed Authorities, a development the report says anticipates a growing role for Asian regulators in converging core requirements. APAC commits to monitoring and reporting reliance pathway performance and to continued engagement with regulators on implementation barriers. The authors caution that the survey reflects industry perspectives and carries potential response bias, variability in local association processes and differences in pathway maturity across economies, presenting the findings as descriptive evidence of real-world operational patterns rather than regulator-verified performance data.

Subject of Research: Regulatory reliance pathways for medicine approvals across Asia-Pacific economies

Article Title: Optimize reliance pathways to advance patient’s access through good regulatory practice: recommendations from the Asia Partnership Conference of Pharmaceutical Associations (APAC)

Article References: Ong, S. H. M., Singh, M., Kanno, M., Long, S. M., Wong, K. C., Sathaye, A., Binos, R. S. R., Sou, H., & Chong, S. S. F. (2026). Optimize reliance pathways to advance patient’s access through good regulatory practice: recommendations from the Asia Partnership Conference of Pharmaceutical Associations (APAC). AAPS Open, 12(1), Article 48. https://doi.org/10.1186/s41120-026-00186-y

Image Credits: AI Generated

DOI: 10.1186/s41120-026-00186-y

Keywords: regulatory reliance, APAC, drug approval, patient access, public assessment reports, National Regulatory Authorities, post-approval changes, new drug applications, WHO Good Reliance Practices, review timelines, harmonization, pharmaceutical regulation