Helping healthcare companies navigate Asia’s regulatory environment

A Singapore-based organisation is working with industry members and national authorities to build regulatory capacity and encourage policy innovation in Asia, making the road to reaching Asian customers a less bumpy one for healthcare companies. Enhancing the regulatory environment for companies While Asia’s massive population offers an exciting opportunity for growth-seeking healthcare businesses, the speed at which they can roll out their products in the region hinges on an important factor: the complex and critical task of navigating the regulatory environment and systems for pharmaceutical products and medical devices across the region. Peoples’ health and well-being depend on sound regulatory frameworks that help them to access the safe and quality treatments they need in a timely way. This is a challenge the Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School in Singapore recognises.
The Singapore’s Centre of Regulatory Excellence (CoRE) at Duke-NUS Medical School. Photo credit: CoRE
Its aim is to enhance the regulatory environment so that national regulatory systems are strengthened and converged, which helps companies to develop, commercialise and deliver new healthcare products to populations across Asia with greater efficiency. CoRE’s Executive Director, Professor John Lim says: “What we’re doing is shifting the needle away from poor regulation and inappropriate barriers towards “smart” and excellent regulation that facilitates access to safe, effective and quality medicines and medical devices.”
CoRE’s Executive Director, Professor John Lim shares that one of CoRE’s aims is to shift away from poor regulation and barriers towards access to safe, effective and quality medicines. Photo credit: CoRE
Three key gaps in Asia’s healthcare regulation  Prof Lim shared that there have been three key gaps in healthcare regulation in Asia. First, many multinational corporations (MNCs) do not have enough people with sufficient training to engage regulators effectively and obtain licensing decisions quickly, and regulatory authorities also lack capacity. Additionally, regulatory requirements across the region are fragmented and often country-specific, resulting in companies having to reconfigure their submissions for each country. Finally, there are few platforms where healthcare regulators and regulatory professionals from MNCs come together in a neutral setting to discuss and take a deep dive into solving regulatory issues. With these gaps in mind, the goals of CoRE are to develop talent in regulatory roles, promote policy innovation, and establish networks. Building a strong talent pool in regulatory skills and medical knowledge To achieve its goals, CoRE is investing in education and training for regulatory professionals in the region, holding workshops not just in Singapore but also countries such as Cambodia and Laos. CoRE received funding from the Asian Development Bank in 2015, for instance, to look at the regulatory landscape linked to malaria in the five ASEAN countries in the Greater Mekong sub-region. Using interviews and other research tools, it assessed needs to identify gaps and develop roadmaps for capacity-building. CoRE was then able to begin offering relevant programmes to enhance the capabilities of regulatory professionals. CoRE’s Deputy Director, Associate Professor Silke Vogel, says that the centre seeks to cover the whole career spectrum when playing its educational role, so that participants “understand regulatory science and technical skills, and move their career forward [with] advanced technical skills and soft skills, then with leadership and strategy.”
CoRE’s Deputy Director Associate Professor Silke Vogel says that the centre seeks to cover the whole career spectrum when playing its educational role. Photo credit: CoRE
Besides being able to obtain graduate certificates in areas such as pharmaceutical regulation, working professionals attending CoRE’s workshops can accumulate credits that will eventually build towards a master’s degree in regulatory science over a period of three to five years. Singapore-based Dr Sandra Lim, Bayer’s Asia-Pacific head of regulatory affairs for pharmaceuticals and consumer health, says that these initiatives have been useful, as there are not many courses where regulatory professionals can be educated. “CoRE workshops and conferences offer knowledge-sharing forums as well as opportunities for gaining insights from regional regulators. Topics discussed include emerging trends such as personalized medicine or medical software which the industry is already bringing into their R&D programmes”, Dr Sandra Lim said. Assoc. Prof Vogel shares that when developing programmes, CoRE is guided by three themes. “First, empower individuals to make sound scientific decisions in the interest of public health. Second, use good regulatory practices that have been published. Lastly, facilitate regulatory convergence, so people adopt the same guidelines.” Fostering regulatory collaboration Along with developing regulatory expertise, promoting policy innovation and greater regulatory convergence is also a key component of CoRE’s work. “The creation of this centre was (designed) to establish a neutral space for regulators to come together and to bring in industry to hear what regulators are saying,” explains CoRE’s Prof Lim. “In a safe harbor setting, people are more willing to talk – that’s powerful.” Bayer’s Dr Lim explains that CoRE’s workshops and conferences not only offer a forum for knowledge-sharing. They are also platforms for businesses to understand regional regulators’ perspectives on emerging topics such as personalised medicine, medical software and real-world evidence, many of which are currently explored under R&D. She points out that CoRE can help to fill knowledge gaps, so that by the time the industry makes submissions for approval, regulators are better equipped to review the relevant data. “The upside to the business would be a smoother review process, which should result in less delay in obtaining approvals or a reduction in the rejection rate,” says Dr Lim. This also links with one of the aims of CoRE, to encourage regulators across the region to develop innovative policies and rationalise systems. Facilitating the delivery of products through an ‘abridged route’, for example, means that regulators rely on decisions by trusted counterparts in other countries, look more at clinical and quality aspects, and determine whether there are issues that need to be addressed in a local context, rather than attempting to conduct full evaluations for every product.  Even well-established regulatory agencies in developed countries are increasingly exploring such “reliance” approaches which the World Health Organisation strongly advocates for regulators in developing countries. Leveraging Singapore’s expertise Thanks to Singapore’s regulatory expertise and support from senior Asia-Pacific regulatory executives based in the country, CoRE remains well positioned to support the development of regulatory talent and frameworks across the region. To date, it has already been able to apply its expertise in specific medical fields. As the Centre of Excellence for advanced therapies for the APEC Regulatory Harmonisation Steering Committee, for instance, CoRE has run two workshops on advanced therapies and delved into areas such as regulatory frameworks and product development. In the future, the Centre will also continue to establish platforms for collaboration and help regulatory professionals hone their skills. “No one else is quite doing what we’re doing,” says Prof Lim. “While other countries do have centres that look at various concerns or provide education, no other centre has a full spectrum [of initiatives] and is doing so much to strengthen the [healthcare] system. It is a uniquely Singapore initiative.”