Quan Tran, VP Regulatory Affairs APACMed, tells us more about the implications of the partnership and how it will benefit APACMed members.
What is the AHWP, and what is its role?
The AHWP was founded in 1996 as a non-profit organisation by a group of experts representing the medical device industry and regulatory authorities.
The main goals of the organisation are to develop and recommend approaches for the convergence and harmonisation of medical device regulation in Asia and beyond. It also helps facilitate the transfer of knowledge and expertise amongst regulators and industries, and enables capacity building in member economies. Over the last twenty years, AHWP has established itself as a powerful international platform for information exchange and best practice sharing with regulators and industry. In more recent years, it has stepped up its capacity building efforts, with a focus on member economies with emerging regulations.
The AHWP is currently chaired by Dr. Hee-kyo Jeong, Director-General of Medical Device Evaluation Department, Korea Ministry of Food and Drug Safety (MFDS).
You are the current Vice President, Regulatory Affairs for APACMed, but you are also involved in the AHWP; can you tell us more?
I have worked in the healthcare industry for over the two decades, holding senior Regulatory, Clinical and Quality roles in various multinational companies such as GSK, Johnson & Johnson and GE Healthcare.
As an industry member, I have been actively engaged with AHWP activities; I spearheaded two working groups and served a term as the Advisor to the AHWP chair.
We are observing rapidly evolving regulatory landscapes across many AHWP member economies, and I believe it is critical for regulators and industry stakeholders to collaborate across the entire process, from the formulation of regulations to their smooth implementation.
As the current Vice Chair of AHWP, alongside my role at APACMed, I am delighted to see both organisations collaborating on a formal basis, and I believe this is partnership will truly allow us to jointly shape the future of healthcare across the region.
What exactly does the partnership entail, and how will it benefit APACMed members?
First, it is important to highlight that this collaboration is beneficial for both organisations.
APACMed has a very broad reach. In terms of industry representation, our members include both SMEs and MNCs across the region. We are represented at APEC RHSC (Asia Pacific Economic Cooperation – Regulatory Harmonization Steering Committee) as Industry Coalition Lead, and are also a member of GMTA (Global Medical Technology Alliance). Moreover, APACMed counts many local associations such as MTAA (Australia), SMF (Singapore Manufacturing Federation) and AMMI (Malaysia) as its members.
Beyond industry players, many APACMed members have long standing relationships with regulatory authorities, health care professionals and academics. This means we can bring our collective expertise closer to AHWP members including regulatory authorities, and in doing so, we can make a significant contribution to harmonisation.
Regulators and industry share a common vision for timely access to safe, and quality products. I believe the partnership will drive greater harmonisation that benefits patients and results in greater efficiencies for industry players.
As Official Liaison Member of AHWP, APACMed will engage in proactive dialogue with AHWP member economies in the development of guidelines, as well as play an active role in capacity building in support of the emerging regulations in the region.
APACMed members can more effectively leverage AHWP as an advocacy platform for common issues, through workgroup participation in the development of guidelines in premarket, post market, QMS and clinical performance and participation in capacity building in country training and annual workshops.