Next week, Japan will host expert discussions on strengthening regulatory systems, fostering international collaboration, and advancing towards universal health coverage.

This discussion is part of the Asia Partnership Conference of Pharmaceutical Associations (APAC), an industry-driven initiative focused on expediting the availability of innovative medicines across Asia. For more than 10 years, APAC has served as a platform for meaningful and solutions-oriented exchanges among regulatory authorities, academia and industries on timely topics to improve access to innovative medicines in the region.

Setting the stage for unpacking barriers to access 

Japan is a perfect convenor, as the country has been a critically important partner in developing new medicines for patients around the world and has taken a leading role on facilitating regulatory cooperation at international level.

However, innovation alone isn’t sufficient if it doesn’t reach patients. Various challenges hinder the journey of a medicine or vaccine from development to patient use. These challenges encompass regulatory pathways, reimbursement processes, healthcare financing, and infrastructure limitations. Tackling these obstacles necessitates open dialogue and collaborative efforts from all stakeholders.

Harnessing regulatory reliance for the benefit of patients

As the 13th edition of APAC approaches, attention turns to regulatory reliance as the hallmark of a modern, efficient regulatory framework and a 21st century regulatory tool. It offers a pathway for regulatory authorities to consider evaluations conducted by others while maintaining accountability for their decisions. This approach is particularly crucial considering the World Health Organization’s observation that less than 30% of global regulatory authorities possess all the necessary functions to ensure the safety and efficacy of medical products.

By avoiding duplicative reviews and optimizing resource allocation to facilitate approvals, the use of regulatory reliance ultimately leads to faster patient access to safe and effective medicines. Share on X

Coupled with the use of digital platforms (e-labelling and e-signatures), regulatory reliance can encourage innovation by reducing some barriers from lab to the bedside. Similarly, it provides a more predictable environment for pharmaceutical companies. In the context of common health-related challenges, such as ageing populations or rare diseases, there is a growing need for innovative medicines.

Setting opportunities for progress

We’ve seen meaningful progress in the implementation of reliance in the past few years, a practice accelerated by the exceptional circumstances of the pandemic. The International Coalition of Medicines Regulatory Authorities (ICMRA) has supported action on a global scale by enabling exchange of knowledge and experiences among regulatory authorities, fostering trust and a supportive environment for regulatory reliance initiatives.

As the WHO moves forward with the WHO-Listed Authorities Framework, more positive steps towards gaining access to novel medicines and treatments in different geographies is expected. The Health Sciences Authority in Singapore (HSA) has been one of the first NRAs in Asia to obtain global recognition for its regulatory system, and it is expected that this status could encourage pharmaceutical companies to choose the region as one of the first markets to register innovative medical products.

Looking ahead, it’s crucial to unpack the potential impact of regulatory reliance and address remaining challenges for effective implementation.  By supporting the evolution of regulatory systems alongside medical product innovation, we can pave the way for broader access and improved patient outcomes.

Author

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  Janis Bernat Director, Scientific and Regulatory Affairs j.bernat@ifpma.org