Expert insight

ARC2015: Regulatory Convergence and Best Practices are Next Week’s Hot Topics in Asia

29 January 2015
  • Estelle Michael

The clock is ticking! In just few days, we will be joining friends and colleagues in Chinese Taipei for the Asia Regulatory Conference (4th and 5th of February). The program was crafted by a Programme Committee, which consists of regulatory professionals from regulatory authorities, industry and trade associations including the Taiwanese Food and Drug Association (TFDA), Singapore’s Health Science’s Authority, Switzerland’s Swissmedic, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers and Associations (JPMA), the International Research-Based Pharmaceutical Manufacturers Association (IRPMA) and the R&D-based Pharmaceutical Association Committee (RDPAC). The Programme Committee has held regular ‘check-ins’ with an Advisory Committee, consisting of experts from regulatory authorities both within and outside the region. And, rather excitingly, the conference has been endorsed by Asia Pacific Economic Cooperation (APEC).
So what should be expected from the conference?

On day one, there is a focus on good review practices: thought leaders such as John Lim from Duke-NUS Graduate Medical School (former of the HSA, Singapore) and Lembit Rago of the World Health Organization (WHO) will provide keynote speeches followed by a panel discussion between regulators inside and outside the region. These will provide answers to critical questions: what more is needed to make good regulatory practices a reality for the region? Does it necessarily need regulatory amendments or just changes in working practice? WHO has recently developed guidance on ‘good regulatory practices’ so it seemed timely to hear more about this from the regulatory authorities, such as Taiwan’s TFDA, who were closely involved in developing it.

The second session of day one will draw on the key themes and outputs of the previous ARC (which took place in Singapore in 2012): “Co-operation, Convergence, Competency, Capacity, and Communication.” Cordula Landgraf from Swissmedic will explain how this soundbite has been brought to life through work she has done in collaboration with regulators in Australia, Canada and Singapore.

As it would be hard to hold a regulatory conference discussing the current topic of ‘innovative and alternative’ regulatory pathways, we will hear, in the afternoon of the first day, about progress in this area in United States of America (USA), European Union (EU), and Japan. This session will be hosted by John Skerritt from Australia’s Therapeutic Goods Administration (TGA).

On day two, we will enter a day of discussion focusing on good submission practices. Asia’s trade associations have come together to develop good submission guidance, which they plan to showcase in the opening panel discussion. This will be followed by a reflection focusing on industry’s experience of submitting dossiers in the Association of Southeast Asian Nations (ASEAN) – this being of particular interest in light of the ASEAN harmonization initiative which has, in theory, led to harmonization of dossier content and format.

In the afternoon, we will again look to step beyond the main themes of the conference and hear about initiatives that APEC is driving in relation to sustainable regulatory convergence. We will conclude the conference with a panel discussion reviewing the overall outcomes from the conference and teeing up areas for further action and discussion.

We do believe that the program we have put together is relevant to both the novice and the expert of the Good Regulatory Practices concept.

Have your say and join us and all stakeholders to help contribute to the definition of pragmatic regulatory approaches for improving access to innovative therapies in Asia!


  • Estelle Michael