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

Purpose This study aims to assess the current adoption, implementation challenges, and optimization opportunities of reliance pathways across APAC (Asia Partnership Conference of Pharmaceutical Associations n.d.) economies, with a focus on supporting harmonized regulatory practices, enhancing efficiency, and improving patient access to safe and effective medicines. Methods APAC conducted a structured survey of all 14 member associations across 12 economies to assess the adoption and implementation of local reliance pathways for new drug applications (NDAs), new indications (NIs), and post-approval changes (PACs). Responses were consolidated at the economy level and analyzed for pathway availability, implementation barriers, documentation requirements, workload, regulatory queries, review timelines, and future optimization priorities. Results Reliance pathways continued to expand, with Malaysia removing CPP requirements and extending reliance to NIs and PACs, and Vietnam establishing an NDA pathway in 2025. EMA, US FDA, PMDA Japan, and TGA Australia remain the most frequently referenced authorities. Despite growing adoption, implementation challenges persist, such as local-specific requirements that remain in place, requests for additional documentation such as interim reports, and the routine or excessive requirements of final non-public (unredacted) assessment reports (non-PARs), even in abbreviated reliance pathways. Reliance pathways have reduced regulatory queries variably, but improvements in review timelines are inconsistent across economies. To function as intended, abbreviated reliance pathways should primarily leverage publicly available assessment reports (PARs) and approval letters for NDAs and PACs respectively, focusing national reviews on unresolved or locally relevant issues rather than repeated assessments already conducted by reference authorities. Economies unable to meet published timelines should identify operational bottlenecks and implement monitoring systems to improve efficiency. Conclusions APAC will advance Fig. 9 optimization priorities through continued engagement with NRAs and local member associations on implementation barriers, including greater use of PARs as the default scientific basis for abbreviated reviews, removal of non-core interim reports and Q&As, and improved adherence to published timelines. In India, this includes expansion of the current reliance scope to all products and removal of local clinical trial requirements where reliance is applied, in line with WHO Good Reliance Practices. APAC will also monitor and report reliance pathway performance to enhance consistency, transparency, predictability, and adherence to published timelines. Through these actions, APAC aims to strengthen regulatory collaboration and enable faster access to medicines for patients across APAC.