he Philippines FDA currently manages a regulatory backlog of approximately 18,000 applications (statistics from PFDA), while companies continue to submit new applications.

By proposing the integration of Good Review Practices (GRevP) and Good Submission Practice (GSubP), aligning PFDA frameworks with international standards, and embracing reliance as a strategic tool to expedite regulatory approvals, the Philippines’ first GRM Workshop marks an inflection point in the nation’s regulatory landscape.

GRM was first introduced to the region by the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) in 2011, and has been subsequently advanced by APEC, Japan’s Pharmaceutical and Medical Devices Agency (PMDA), and the Taiwan FDA, through annual training workshops for regulators from APEC economies keen to upskill and optimize their review processes.

Two Sides of the Same GRM Coin: GSubP

• Good Submission Practice (GSubP), the applicants’ side of this coin, includes presenting a comprehensive explanation of the scientific basis for the reference agency’s decision to the health authority reviewing the new application, in the context of regulatory reliance.
  • The APEC RHSC GSubP Guideline provides applicants general guidance on principles for application.
  • Applicants in the Philippines apply GSubP principles by initiating early discussions with cross-functional teams to align on strategy, requirements, and timelines. Applicants utilize project management tools such as Gantt charts and regulatory checklists to ensure adherence to target submission timelines. In addition, applicants conduct quality reviews of released dossiers and labeling materials to ensure accuracy, consistency, and compliance prior to submission.
  • Applicants in Japan apply the principles from the APEC RHSC GSubP Guideline by leveraging internal regulatory tools, quality-control processes, and effective cross-functional communication to support well-structured, high-quality, traceable submissions that contribute to successful regulatory outcomes.

Two Sides of the Same GRM Coin: GRevP

• GRevP, the regulators’ side of this coin, includes using standard operating procedures (SOPs) and standardized assessment templates and checklists to support the efficiency of the review process (especially when different parts of a document are assessed by different reviewers) and predictability of target review timeframes and deadlines.
• Effective communication management within and between regulator and applicant organizations supports these same goals. For example, pre-submission meetings facilitate proper regulator alignment of multidisciplinary PFDA review teams responsible for different parts of the dossier, and applicant alignment between clinical development and dossier submission plans.
• PFDA applies GRevP to post-approval change (PAC) submissions by requiring a science- and risk-based evaluation of the PAC’s impact on product quality in lieu of a full review and by implementing regulatory reliance when/where possible.

Bridging the Applicant-Reviewer Gap

Collaboration between reviewers and applicants is essential to uphold the GRevP and GSubP principles and frameworks and to promote efficiency, quality, and timeliness of product registration from application submission throughout review and approval. Pre-submission meetings and checklists ensure early alignment, and structured communication channels (e.g., one official point of contact) improve transparency; together, these create predictable processes, schedules, and results. Joint capacity-building workshops can also bring mutual educational and team-building benefits to applicants and regulators.

Japan’s PMDA offers a consultation system that provides an excellent point of reference of ASEAN regulators: In Japan, applicants and authorities discuss strategies and concerns throughout development. Required documents are clearly outlined in notifications and industry guidance, helping applicants reduce nonacceptance and ensure smoother submissions. This consultation framework may serve as a useful reference for regions where similar systems are not yet established. Furthermore, for regions that refer to PMDA’s regulatory opinions, consultation outcomes may contribute to increased certainty in achieving regulatory approval.

Regional Lessons Learned

The Taiwan FDA (TFDA) not only applies reliance in its own reviews but also serves as an APEC GRM Center of Excellence by hosting annual GRM training for local/regional regulators.

Referencing a more mature agency’s assessment does not dilute scientific rigor but reduces duplication by allowing local reviewers to focus on local aspects of their dossier (such as pharmacovigilance or other post-marketing requirements). This efficiency helps resource-constrained agencies reduce their backlog of marketing authorizations and PACs and reduce future costs through time saved.

Effective reliance includes establishing memoranda of understanding (MOUs) with reference agencies to allow access to unredacted assessment reports and specify the management and technology structures used to communicate this information.

Other collaborative regulatory initiatives with an element of reliance that provide good examples of streamlined review for regional regulators include:

• ASEAN Joint Assessment (AJA): This is a formal procedure, established in 2016, in which the same marketing authorization application is simultaneously submitted to all participating NRAs. Assessment work is then carried out together by all participating NRAs, and a joint assessment report is prepared. Each NRA makes its own final decision through their normal decision-making process but based on this joint report. The AJA procedure has evolved with multiple revisions, with most ASEAN NRAs formally including AJA in their regulatory guidelines. However, applicant uptake is selective. Longer timelines, dual submission (to ASEAN and national portal), and country-specific requirements make AJA less competitive than national reliance pathways. The AJA framework will need to be optimized in these areas to drive broader use.
• ACCESS Consortium: A coalition of national regulatory authorities from Australia, Canada, Singapore, Switzerland, and the UK that works together to promote alignment of regulatory requirements for clinical development and regulatory submission of health products in these nations, established in 2007. The ACCESS Consortium allows Singapore’s HSA to participate in parallel, work-sharing reviews, reducing duplication and positioning Singapore for first market filing with other consortium members, leading to faster approvals. ACCESS Consortium filings are well-leveraged by Singapore-based applicants.

Workshop Debrief and Plans for 2026

At the GRM Workshop Debrief, the PFDA expressed openness to reinstituting pre-submission meetings with industry—a critical step toward improving early regulatory alignment, reducing rework, and shortening review cycles—and agreed to schedule and begin planning the next annual GRM workshop in 2026.