Opening Speech by Mr Gan Kim Yong, Minister for Health at the Inaugural Scientific Conference of Centre of Regulatory Excellence, Duke-NUS, 5 October 2015, at the Academia

Mrs Tan Ching Yee
Permanent Secretary (Health)

Professor Thomas Coffman,
Dean, Duke-NUS Graduate Medical School Singapore

Professor Sir Alasdair Breckenridge,
Chairman, Advisory Board, Centre of Regulatory Excellence (CoRE)

Associate Professor John Lim,
Executive Director, CoRE

Distinguished guests

            I am pleased to join you this morning for the inaugural Scientific Conference organised by the Duke-NUS Centre of Regulatory Excellence (or CoRE).  I would also like to extend a warm welcome to Dr Margaret Hamburg, Foreign Secretary of the US National Academy of Medicine and former Commissioner of the US Food & Drug Administration, who will be delivering the first CoRE Annual Lecture shortly.        

2          The participation of many experienced and distinguished speakers today underscores the support for CoRE’s mission – namely to boost regulatory leadership capabilities and enhance efficiency of health product regulation systems across ASEAN and the wider Asia-Pacific region.  Bolstering such regulatory capabilities supports the regional growth of biomedical R & D and manufacturing.  More importantly, it ensures that patients in our countries and health systems have timely access to good, safe and effective medicines and medical devices, including generics and bio-similars.         

The Need for Better Regulation

3          In today’s world, we face a range of health challenges, including evolving disease threats such as the Middle East Respiratory Syndrome (MERS) and Ebola.  Biomedical R&D strives to find effective treatments for these, as well as chronic conditions like heart disease and diabetes which are increasingly common in today’s affluent societies.  In the first quarter of this year, close to 4,000 industry-funded clinical trials were carried out in Asia [1], a reflection of the vibrant biomedical research here. The increasing research investment makes it imperative to put in place a robust regulatory framework that ensures patient safety.

Singapore’s Health Products Regulatory System

4          The formal registration of medicines began in Singapore in 1987 under the Medicines Act.  The Health Sciences Authority (or HSA), a statutory board under my Ministry, has been proactively updating and refining our regulatory system for health products.

5          HSA leverages on global cooperation and information exchange to strengthen our regulatory processes. Singapore became the first Asian member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in 2000, demonstrating our commitment to promoting international standards for Good Manufacturing Practice of medicines.  Singapore has also been an active reporter of adverse drug reactions to the World Health Organization (WHO) since 1994. We have consistently ranked first in the world for Individual Case Safety Reports per million inhabitants since 2011.

6          As a small country, we take a pragmatic approach in our regulation.  Where medicines or medical devices have already been licensed in a reputable jurisdiction, HSA offers expedited approval routes, with abridged assessments based on valid reference data from approvals in these jurisdictions.  Where the products have not been licensed elsewhere, HSA will conduct a full evaluation of them. In this, HSA is able to leverage on a wider talent base to do more, and provide more responsive regulatory decisions without compromising scientific robustness.  It is a win-win strategy for all parties, and an innovation borne out of necessity.  We like to call this our “confidence-based” regulatory approach.

Towards Convergence of Regulatory Requirements

7          This approach is just one of the many possible strategies to cope with the issue of different regulatory requirements in different countries.  Over the years, there have been several efforts to promote harmonisation such as the International Conference on Harmonisation, or ICH, started in 1990.  Other ongoing regional efforts include the ASEAN Product Working Groups for Pharmaceuticals and Medical Devices, and initiatives across the APEC economies.

8          Despite these efforts, regulatory requirements across Asia and the Asia-Pacific are still relatively fragmented.  While common technical documents and requirements have been defined, there still remain differences in legal and regulatory frameworks.  This has resulted in country-specific requirements, which requires applicants to submit multiple applications to different countries within a region to get approval for the same product.  This could result in approval delays, higher costs and slower access to beneficial therapeutic products.                

9          Nevertheless, there is now increasing commitment by regulators and industry to explore convergence of regulatory standards within and across regions, and also to explore work-sharing and reliance on other agencies.  Such approaches enable smaller agencies to better cope with expertise constraints, especially when reviewing more complex therapeutic products.  As this Conference focuses on convergence and collaboration, I encourage you to take this opportunity to consider how to translate these important ideas into realistic systems that can enable patients and consumers in our various countries to have more timely access to safe and effective medicines and medical products.   

Working Together for Capabilities Development

10        Even with enhanced collaboration, there is still a continuing need to build a larger pool of regulatory professionals and expertise in Singapore and across Asia.  CoRE was established following feedback to Singapore’s Economic Development Board from industry and regulators about the need to address this capacity and capability gap.  A lack of expertise affects the ability of regulatory agencies to conduct timely evaluation of product applications, especially for new therapies where the science is rapidly evolving.  The lack of regulatory expertise also impacts the ability of companies to constructively engage with regulatory authorities or to produce quality documentation.

11        CoRE therefore aims to bring together industry players and regulators to develop regulatory leadership capability and grow the pipeline of regional regulatory talent.  Strengthening regulatory expertise and executive leadership skills is important for boosting the competence and confidence of regulatory agencies and industry.  This would help the region to better align with international standards, bridge knowledge gaps and promote a sound grasp of regulatory science as well as provide a strategic perspective of the need for regional collaboration.

12        CoRE’s other goal is to facilitate and support innovation in policies and systems for streamlining health products regulation.  This includes convening key opinion leaders from regulatory agencies, industry and academia for roundtables and workshops.  Participants can then discuss evolving scientific trends, exchange ideas, and explore practical innovations for regulatory systems.

Conclusion

13        This Scientific Conference serves as a useful platform for participants to discuss ways to improve regulatory effectiveness, and to seek convergence in our regulatory standards where possible.  I look forward to the translation of these themes into enhancements of our regulatory systems across the region.

14        I have no doubt this will be a stimulating Conference for all participants.  On that note, I wish all of you a very fruitful meeting.

[1] US National Institutes of Health