Advancing equitable patient access across the Asia-Pacific region and globally

The announcement of HSA and MFDS as WHO-Listed Authorities (WLA) is the first-of-its-kind global recognition of Asian agencies—outside of Japan—meeting international regulatory standards, instilling confidence in the safety and reliability of medical products from these markets.

Five key patient access implications of the WHO listing of HSA and MFDS:

1. Promoting regulatory convergence
Achieving regulatory harmonization has been a critical goal in the Asia-Pacific (APAC) region, given the diverse levels of regulatory maturity in the region—with some regulators lacking the ability and resources to regularly assess a wide range of emerging health technologies.

While formal harmonization has proven elusive over the years in the APAC region, this WLA ruling brings the different national regulatory authorities in the region closer to regulatory convergence, encouraging mutual guidance and building confidence in regional decisions.

With this, APAC markets can optimize their regulatory capabilities in a way that effectively prioritizes public health, without compromising innovation.

2. Impact on global procurement decision-making
As WLAs, decisions by HSA and MFDS will likely be considered on a par to those from stringent regulatory agencies such as the US Food and Drug Administration and European Medicines Agency.

International as well as national organizations that are responsible for drug and vaccine procurement, such as the Global Drug Fund, often depend on these decisions to guide their product purchasing choices, directly impacting healthcare access for millions of people, especially those in low- and middle-income countries.

3. Enhancing health security
The inclusion of two Asian market authorities as WLAs hopefully marks a promising start, encouraging other Asian markets to build regulatory capacity and incorporate controls to meet international regulatory standards, enabling access to quality-assured health products in the region and beyond.

4. Fostering an open and innovative environment
As more agencies gain global recognition, manufacturers from the APAC region (especially from resource constrained settings with limited regulatory capacity) will have more avenues to get their novel as well as their generic products assessed and accepted onto the global stage. This could help streamline assessment processes for reviewing novel, effective therapeutic options and facilitate timely as well as optimal medical access.

5. Bridging the access time lag
Global and local manufacturers now have more incentive to prioritize product launches in the APAC setting, deviating from a conventional EU/US-first entry approach. This could enable patients in APAC to get early access to novel lifesaving medicines and treatments.

References:

1. Landmark listing of first three countries as WHO-Listed regulatory Authorities. (2023) https://www.who.int/news/item/31-10-2023-landmark-listing-of-first-three-countries-as-who-listed-regulatory-authorities
2. Lim, J.C.W. Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific. Ther Innov Regul Sci 52, 751–754 (2018). https://doi.org/10.1177/2168479018769285
3. Macé C, Rägo L, Ravinetto R. How the concept of WHO-listed authorities will change international procurement policies for medicines. BMJ Global Health (2022). https://gh.bmj.com/content/6/Suppl_3/e008109
4. Mahoney R, Hotez PJ, Bottazzi ME. Global regulatory reforms to promote equitable vaccine access in the next pandemic. PLOS Glob Public Health, 3(10): e0002482 (2023). https://doi.org/10.1371/journal.pgph.0002482