Advancing Pharmaceutical Regulatory Cooperation in Asia: The Vision and Challenges of GMP Inspection Reliance

As the global pharmaceutical industry becomes increasingly internationalized, regulatory authorities across the world face a shared challenge: how to effectively allocate limited resources while ensuring drug quality and patient safety. 

On April 22 during the “GMP Inspection Reliance” session at The 14th Asia Partnership Conference of Pharmaceutical Associations, regulatory representatives and industry experts from various Asian countries focused on how to achieve mutual recognition of GMP inspection results to promote cross-border regulatory cooperation and reduce redundant inspections.

A New Opportunity for Regulatory Trust: Rethinking the Model of GMP Inspection Cooperation

Makoto Ono from the Japan Pharmaceutical Manufacturers Association (JPMA) opened the session by stating, “We are at a critical turning point. This is not just a shift in regulatory models but an opportunity to advance public health across Asia.”

Kentaro Hara from the Pharmaceuticals and Medical Devices Agency (PMDA) shared that over the past decade, Japan has made significant investments in promoting GMP Inspection Reliance. He called on Asian nations to collaboratively build an effective pathway for mutual recognition of inspection results, thereby strengthening patient safety and accelerating the availability of new therapies.

Cooperation in the Face of Diversity: Practical Experiences from Singapore and Malaysia

From a practical standpoint, Singapore and Malaysia are at the forefront of GMP Inspection Reliance in Asia.

Kim Mi Hng from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) emphasized the foundational role of mechanisms that promote inspection compliance. Meanwhile, Li Lian Lim from Singapore’s Health Sciences Authority (HSA) pointed out that, as a market with a diverse pharmaceutical landscape, Singapore actively participates in international organizations such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

More importantly, Singapore has signed four Mutual Recognition Agreements (MRAs) with Australia, New Zealand, South Korea, and ASEAN, allowing mutual recognition of GMP inspection results with these partners. This significantly reduces the administrative and manpower costs associated with duplicate inspections.

These experiences demonstrate both the feasibility and value of promoting reliance but also highlight the challenges in its implementation.

Challenges and Visions for Mutual Trust: Harmonization and Transparency as Pillars

During a panel discussion, participants agreed that regulatory harmonization and information transparency are the two key pillars of successful GMP Inspection Reliance.

Many Asian countries differ significantly in their regulatory frameworks and inspection standards, making full mutual recognition challenging in the short term. However, a gradual approach—such as joint training, quality standard control, and establishing information-sharing platforms among agencies—can help build a foundation of trust and foster deeper cooperation.

It was also noted that industry associations can play an active role by encouraging member companies to engage in international inspection collaboration, thereby elevating overall compliance levels.

Looking to the future, attendees generally believed that once GMP Inspection Reliance is realized, the primary beneficiaries will be both patients and the pharmaceutical industry:

• For patients, new treatments will reach the market more quickly and safely.
• For companies, resources saved from avoiding redundant inspections can be redirected to innovation and market expansion.
• For regulators, limited resources can be focused on high-risk products and critical inspections, improving overall regulatory efficiency.

Conclusion: Trust Begins with Understanding

The implementation of GMP Inspection Reliance is a significant step toward mature pharmaceutical regulatory cooperation in Asia. Although there are disparities in regulatory systems, technical capabilities, and regulatory cultures among Asian nations, it is precisely these differences that highlight the value of trust and collaboration.

This is not a sprint but a long-term effort in system building and values integration. As we promote mutual recognition of GMP inspections, gradually establishing transparent information flows and a unified regulatory language, we can bring safer and more accessible medicines to people across Asia and set a new standard for global pharmaceutical regulatory collaboration.

Author

Oscar Wu

讓生醫資訊更加流通與透明化。