Regulatory Systems Innovation in ASEAN

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Associate Professor John Lim, Executive Director of CoRE

BioSingapore in partnership with Clearstate, Price Waterhouse Coopers (PwC), and the Association of Pharmaceutical Medicine (Singapore) (APMS) conducted a networking event on November 25th at the PwC building, Singapore. Assoc. Prof. John Lim, the Executive Director of Centre of Regulatory Excellence (CoRE) at Duke-NUS shared his thoughts on Regulatory Systems Innovation in ASEAN- especially with regards to health products.

The Biomedical and Life Sciences sectors in Asia hold high potential for the development of new drugs and healthcare solutions. In alignment with this growth, regional regulatory authorities are enhancing their services and interactions with key healthcare stakeholders from patients to healthcare providers and manufacturers, to ensure new, high-value products and services will be delivered to patients in a safe, affordable and timely way. However, both regulators and industry in the region are facing a dearth of suitably qualified and trained regulatory professionals to support rapid development in R&D and the regulatory sciences.

The Centre of Regulatory Excellence (CoRE) was launched in November 2014, located at the Duke-NUS Medical School to provide a neutral academic platform to help regulatory agencies and industry alike to develop deeper competencies in regulatory affairs, especially at mid to senior levels within their organisations. CoRE is also in a strategic position to help foster an environment in which regulatory policies can be developed based on measurable results through improved health outcomes, preventing deaths and illnesses, and enhancing the quality of life.

CoRE is the first dedicated centre of regulatory leadership excellence in Asia for health products regulators, industry and academia, and serves South-East Asia and the wider Asia-Pacific region. It is supported by the Singapore Ministry of Health (MoH) and the Economic Development Board (EDB) and has established an MoU at the Duke-NUS level with the Health Sciences Authority (HSA).

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Challenges faced by regulatory authorities

During his presentation, Assoc. Prof. Lim spoke about some of the difficulties faced by both regulatory authorities and biomedical companies. These include a shortage in regulatory expertise, lack of support systems to facilitate regional regulatory policy innovations and diverse regulatory guidelines across different countries.

CoRE’s strategic goals include ensuring that patients in Asia have timely access to safe, effective, high quality and affordable therapeutic products through excellent regulation.

He also spoke about the implications of the ASEAN Economic Community (AEC) that will come into being on 31 December 2015 to enable regional economic integration. The objectives of the AEC are to transform ASEAN into a region with free movement of goods, services, investment, skilled labour, and freer flow of capital.

On the health product aspects, he spoke about the current status of regulatory harmonisation through the ASEAN Pharmaceutical Product Working Group (PPWG) and Medical Devices Product Working Group (MDPWG). Guidelines are developed through a consensus approach that respects the Asian/ASEAN context and addresses socio-cultural and environmental issues. However, implementation varies due to jurisdictional and country-specific requirements, varying regulatory capabilities and different implementation timelines.

It is hoped that with the advent of the AEC, implementation can be enhanced by streamlining and co-ordination of regulatory processes, improved regulatory competencies and better communication.

 What are the opportunities for innovation in regulatory strategies?

CoRE had conducted a roundtable event in March 2015 and identified certain key issues on “Developing a roadmap for referencing in Asia.” They are as follows:

  • Disparities in regional regulatory requirements and capacities
  • Opportunities for more communication of regulatory decisions among stakeholders
  • Need for more structured frameworks and tools
  • Resource issues.

Keeping these in mind, Assoc. Prof. Lim said that CoRE has initiated a project with the support from the Asian Development Bank and in coordination with the World Health Organisation to enhance the regulatory capabilities of ASEAN member states. This will start with a landscape analysis of regulatory systems in ASEAN using a common template and identifying where gaps exist within and across regulatory systems. He said it is important to engage different stakeholders in the healthcare ecosystem including regulators, industry and academia to accomplish this. Based on these findings, CoRE will prioritise the development of programmes delivered by the Centre. It will also collaborate with relevant institutions and agencies to coordinate initiatives aimed at streamlining and strengthening the regulatory ecosystem in the region.

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He concluded his talk by speaking about CoRE’s education programmes and curriculum which are going to be implemented in phases starting in 2016. These programmes will help build a pipeline of regulatory talent to support Asia’s rapidly-growing healthcare sector. A Masters programme covering Fundamentals in Regulatory Science, Applied Regulatory Science and Regulatory Executive Education will be rolled out over the next few years. This is aimed at working professionals and adapted from the Duke-NUS “TeamLEAD” approach, combining e-learning and workshops so that working professionals can accumulate credits on a modular, part-time basis.

About BioSingapore

BioSingapore was established in May 2004 as an industry association for life sciences businesses in Singapore with the support of the Economic Development Board of Singapore. BioSingapore’s mission is to encourage and foster Singapore’s Bioscience enterprises and contribute to Singapore’s continual economic growth. BioSingapore creates awareness, develops and promotes business networking opportunities and maximises investment and employment into this upcoming sector. BioSingapore also complements initiatives by the Singapore government to develop the Nation’s Biomedical Sciences industry.