Cross-Border Trust and Transparency: The New Landscape of Bridging the Regulatory Review in the Asia-Pacific

As global pharmaceutical regulation evolves, “reliance” has become a key strategy for improving review efficiency and accelerating access to innovative drugs. The World Health Organization (WHO) highlights that strong regulatory systems rely not only on capacity and consistency but also on fostering cooperation through transparency and predictability.

According to the WHO’s Good Regulatory Practices (GRP) guidelines, transparency is one of six core principles. This means regulatory agencies should clearly outline their standards and review procedures so applicants know what to expect. In turn, this boosts efficiency and builds trust in the system.

From Concept to Implementation: Lessons from Vietnam, Malaysia, and India

In 2024, Vietnam emphasized that “reliance” must go beyond policy statements—it requires full readiness from national regulatory authorities and all stakeholders. Huyen Do from PG Vietnam underscored that predictability and transparency are essential to achieve “informed reliance.”

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) launched its Facilitated Registration Pathway (FRP) in 2019, allowing applications within two years of approval by a reference authority. Based on practical experience, the policy was revised in 2023 to extend the submission period to three years and refine the process, including steps like Sameness Verification and Risk-Based Evaluation. As Siti Noor Haryani Binti Ismail from NPRA put it, “Reliance is not about doing less—it’s about doing it smarter.”

India has taken a tech-forward approach, focusing on digital collaboration tools and real-world evidence to advance global regulatory convergence. Key priorities include defining the scope of applications, aligning with international standards, improving communication, and leveraging digital solutions to enhance transparency and efficiency.

Regional Progress: From Japan’s PMDA to the ASEAN Joint Assessment

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has opened an Asia Office to promote scientific exchange and regulatory cooperation across the region. The agency is a leader in advancing regulatory science and harmonization to support capacity building in neighboring countries.

Meanwhile, the ASEAN Joint Assessment (ASEAN JA), launched in 2017 with WHO support, represents a collaborative model for regional drug approval. However, participation has been limited—mainly due to issues with transparency and predictability. Reports from APAC recommend streamlining the process and clarifying procedures to encourage broader adoption and faster approvals.

Thailand’s FDA is proactively addressing these challenges. Worasuda Yoongthong highlighted initiatives such as implementing a public manual, establishing consultation mechanisms, and launching an e-tracking system to make the review process more visible and predictable. Thailand also recommends considering both ICH member regions and high-potential R&D countries—like India, China, and South Korea—as reference points for reliance-based evaluations.

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Author

Steven Chung

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