Philippines FDA Draft Guidance: Adoption and Implementation of Good Registration Management (GRM), Good Review Practice (GRevP), and Good Submission Practice (GSubP) for Pharmaceutical Products

Sharan Murugan
10 minutes ago
3 min read

The Philippines Food and Drug Administration (FDA) is advancing its regulatory framework by adopting internationally aligned practices to improve the quality, transparency, and efficiency of pharmaceutical product regulation. The draft circular Adoption and Implementation of Good Registration Management (GRM), Good Review Practice (GRevP), and Good Submission Practice (GSubP) for Pharmaceutical Products introduces a structured and integrated approach to both regulatory submissions and review processes, aligning national practices with global standards.

This guidance establishes Good Registration Management (GRM) as a central framework for improving how pharmaceutical products are regulated in the Philippines. It brings together Good Review Practice (GRevP) and Good Submission Practice (GSubP) into a coordinated system that ensures submissions are of high quality and reviews are conducted in a consistent, transparent, and efficient manner.

This circular applies broadly to the submission and review of pharmaceutical products and related regulatory activities. It includes licensing of pharmaceutical establishments, marketing authorisations, clinical trial approvals, post-marketing regulatory actions, and other scientific and technical evaluations.

Good Registration Management (GRM)

Good Registration Management serves as the overarching framework that integrates submission and review processes into a unified system. It ensures that regulatory procedures are well-managed, efficient, and aligned with international best practices. Through GRM, the FDA aims to create a regulatory environment that is predictable, transparent, and capable of supporting timely decision-making. It also promotes collaboration and mutual trust with other regulatory authorities by aligning processes with global standards.

Good Review Practice (GRevP)

Good Review Practice is based on WHO guidance and focuses on improving the quality and consistency of regulatory reviews. It ensures that decisions are based on scientific evidence and are conducted in a transparent and structured manner.

Under GRevP, the FDA is expected to establish clear policies and defined responsibilities for reviewers, apply standardised assessment templates, and implement peer review and quality control mechanisms. It also promotes the use of reliance pathways and scientific advice to enhance efficiency. Transparency is strengthened through defined timelines, documentation, and publication of regulatory summaries where appropriate. These measures collectively ensure that regulatory decisions are consistent, predictable, and scientifically robust.

Good Submission Practice (GSubP)

Good Submission Practice provides guidance to applicants on preparing high-quality regulatory submissions. It emphasises that dossiers must be complete, well-structured, and aligned with internationally recognised formats.

Applicants are expected to follow standards such as the ASEAN Common Technical Dossier (ACTD) or the ICH Common Technical Document (CTD), ensuring consistency and facilitating efficient review. By improving the quality of submissions, GSubP reduces the likelihood of delays, improves communication between applicants and regulators, and supports faster and more reliable decision-making.

Integration of GRM, GRevP, and GSubP

The integration of GRM, GRevP, and GSubP creates a comprehensive regulatory system where high-quality submissions are matched with high-quality reviews. This coordinated approach improves overall efficiency, reduces duplication, and enhances the predictability of regulatory outcomes. It also strengthens stakeholder confidence by ensuring that regulatory processes are transparent, consistent, and aligned with global standards.

Training and Capacity Building

To support implementation, the FDA will provide training and capacity-building programmes for reviewers, applicants, and decision-makers. These initiatives aim to ensure that all stakeholders understand and apply the principles of GRM, GRevP, and GSubP consistently. Continuous training also supports adaptation to evolving regulatory expectations and scientific advancements.