APEC regulators converge on drug approvals, but uneven implementation slows gains

A cross-sectional assessment of regulatory convergence across the 21 member economies of the Asia-Pacific Economic Cooperation (APEC) has found substantial progress in some areas of pharmaceutical regulation and persistent gaps in others. The study, conducted by the APEC Regulatory Harmonization Steering Committee (RHSC) and published in AAPS Open, measured adoption of eleven agreed Key Performance Indicators (KPIs) using survey data collected in 2025 and compared the results with baseline measurements from 2019 and 2020. The strongest performers were information sharing, achieved by 91 percent of economies (19 of 21), and mutual recognition arrangements, achieved by 62 percent (13 of 21). Yet the analysis also revealed a recurring pattern: economies that formally adopt a best practice frequently retain procedural requirements that erase much of the intended efficiency gain, a distinction the authors describe as the difference between adoption and effective implementation.

The RHSC, which reports to the APEC Sub-Committee on Standards and Conformance, promotes voluntary regulatory convergence among member economies with the aim of minimizing duplication, improving predictability, and expediting patient access to quality, safe, and effective medical products. Since 2018, its KPI framework has tracked progress in four priority areas: reducing reliance on Certificates of Pharmaceutical Product (CPPs), increasing acceptance of PIC/S Good Manufacturing Practice (GMP) inspection outcomes, enabling multisite marketing authorizations, and broadening reliance and work-sharing pathways. The COVID-19 pandemic both accelerated and challenged these efforts, the study notes, with emergency procedures, expanded reliance practices, remote and hybrid GMP inspections, and expedited joint assessments speeding access to vaccines, therapeutics, and diagnostics, while also exposing continued CPP use, inconsistent mutual inspection reliance, and limited digital interoperability for dossiers and GMP reports.

Methodologically, the study was a KPI-based cross-sectional analysis. The APEC Secretariat distributed an updated survey to national regulatory authorities across all 21 member economies on 6 January 2025, with responses requested by 22 January 2025 and reminder communications issued thereafter. The instrument covered participation in information-sharing initiatives, confidentiality commitments, acceptance of PIC/S GMP certificates, establishment of mutual recognition agreements, minimization of CPP requirements, permission for multiple manufacturing sites under a single license, regulatory reliance practices, and participation in international bodies including ICH, IPRP, and PIC/S. Responses were compiled as received, and where a submission was incomplete, ambiguous, or inconsistent with an economy’s known regulatory framework, follow-up correspondence and documentary validation were undertaken. Economies providing no response for a given indicator were treated as missing and excluded from that indicator’s denominator, unless documentary evidence permitted independent validation.

A central design feature distinguishes adoption from effective implementation. Each KPI is scored as a binary measure of adoption: an economy meets the indicator where its regulatory framework formally permits the practice. To probe whether adoption delivers the intended regulatory outcome, economies meeting a KPI were additionally assessed against an effective implementation criterion. For the multisite licensing indicator, for example, effective implementation required both that adding a manufacturing site be handled as a post-approval change rather than a new product license application, consistent with ICH and WHO guidance, and that switching between approved sites be permitted without prior case-by-case authorization. Implementation was scored as a secondary, nested measure that did not alter the primary denominators, preserving comparability with the 2019/2020 baseline. The authors caution that headline KPI results should therefore be read as measures of adoption.

The indicator-level results show a mixed picture. Confidentiality requirements with other APEC economies were held by 76 percent of economies (16 of 21) in 2025, up from 71 percent (15 of 21) in 2020, with Chile the addition that year. Information sharing has been stable since 2019 at 19 economies, with no change in survey responses for 2025. Mutual recognition arrangements rose from 57 percent (12 of 21) in 2019 to 62 percent (13 of 21) in 2025 following New Zealand’s addition. Eighteen economies, more than 85 percent, now accept GMP certificates issued by PIC/S members or under mutual recognition agreements to reduce portions of a full inspection, with Peru adopting the practice in 2025; only China, Papua New Guinea, and the Russian Federation do not accept such certificates. The authors identify GMP certificate acceptance as the indicator most used by APEC regulators to demonstrate convergence.

Progress on CPP removal has been steady. In 2019, eight economies did not require a CPP from another reference agency for some or all drug registration applications; Chile, Papua New Guinea, and Chinese Taipei joined by 2020, and the Republic of Korea and Malaysia by 2025, bringing the total to 13 of 21 economies, or 63 percent. Nevertheless, eight economies still require CPPs or use them as administrative documentation, which the study says leads to redundant document review because formats and timelines remain inconsistent and rooted in legacy processes. As one illustration of shifting practice, the US Food and Drug Administration ceased issuing CPPs for products not exported out of the United States from June 2020. The paper suggests an alternative system in which the country issuing a CPP could instead issue an approval letter for the product.

Multisite licensing shows the adoption-implementation gap most clearly. In 2025, 17 of 21 economies, or 81 percent, permitted multiple manufacturing sites under a single license, up from 9 economies in 2008, 15 in the first quarter of 2020, and 17 in 2025. Among the 17 economies meeting the KPI, however, six, or 35 percent, continue to manage the addition of a manufacturing site as a new product license rather than a post-approval change, and switching between approved sites is not automatic, requiring additional regulatory steps. The study highlights Hong Kong-China as highly restrictive: multiple sites under a single license are generally not permitted across different manufacturing activity types, including drug product bulk manufacturing, packaging, and release, and switching from a primary site to an alternative requires prior approval from the Department of Health. The authors state this undermines the intended efficiency gains and perpetuates supply inflexibility, with significant impacts noted for Hong Kong, Indonesia, and Russia.

Reliance practices show similar partial implementation. Sixteen economies, 75 percent, follow reliance pathways in their regulatory frameworks, mainly linked to New Drug Applications but sometimes extending to post-approval variations, and 14 economies, 67 percent, give significant weight to assessments by other reference agencies within shorter timelines than their standard pathways, an increase from 12 economies in 2020. On re-testing, however, only ten economies, 48 percent, do not require secondary quality control testing for importation or registration purposes, unchanged since March 2020, although Malaysia can rely on GMP certificates to waive re-testing. Seven economies, 33 percent, may grant exemptions based on other conditions such as technical limitations or low import volumes, and three economies, 14 percent, grant no exemptions. The study observes that while over 85 percent of regulators accept GMP certificates, only roughly half waive re-testing, a partial application of reliance that continues to produce regulatory duplication, increased costs, and reduced efficiency across the product lifecycle.

Overall, 67 percent of APEC economies, 14 of 21, have implemented at least six of the eight RHSC KPIs, three economies have implemented all eight, and one has implemented two. The authors note that WHO-listed authorities designated as WHO Reference Agencies achieved at least six of the eight KPIs, but that limited data prevent any correlation between KPI adoption and regulatory system maturity under the WHO Global Benchmarking Tool, which not all economies have undergone. The study’s acknowledged limitations include self-report bias, variation in interpretation of KPI definitions, incomplete response rates, and the binary construction of the indicators, which the authors say means reported achievement rates should be interpreted as upper bounds on functional regulatory convergence. Looking forward, the RHSC is developing Phase 2 KPIs, and the paper suggests future indicators could consider pharmacovigilance, supply chain security, digital regulatory systems, and coordinated oversight of internet-based risks, alongside expanded lifecycle reliance, scaled work-sharing mechanisms building on models such as Project Orbis, the ACCESS Consortium, and the ASEAN Joint Assessment Coordinating Group, and targeted capacity building in the areas of lowest convergence.

Subject of Research: A KPI-based cross-sectional assessment of regulatory convergence progress and implementation gaps among the 21 APEC member economies

Article Title: Tracking regulatory convergence in Asia-Pacific Economic Cooperation (APEC): progress and gaps in key performance indicators

Article References: Chong, S. S. F., Kaur, A., Abdoo, M., Stewart, J., Obscherning, E., Wu, P., Vessoskie, J., Nayouki, Y., Lim, J. C. W., Tan-Koi, W. C., & Auclair, J. R. (2026). Tracking regulatory convergence in Asia-Pacific Economic Cooperation (APEC): progress and gaps in key performance indicators. AAPS Open, 12(1), Article 62. https://doi.org/10.1186/s41120-026-00198-8

Image Credits: AI Generated

DOI: 10.1186/s41120-026-00198-8

Keywords: APEC, regulatory convergence, key performance indicators, GMP certificates, mutual recognition, Certificates of Pharmaceutical Product, multisite licensing, regulatory reliance, RHSC, pharmaceutical regulation, work sharing, quality control testing