WHO's Inclusion of Singapore and South Korea Boosts Healthcare Manufacturing Opportunities

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In October 2023, the Technical Advisory Group for the World Health Organization (WHO) Listed Authorities (TAG-WLA) reached an agreement to suggest adding three markets to the WHO-Listed Authorities (WLAs): Singapore's Health Sciences Authority (HSA), the Republic of Korea's Ministry of Food and Drug Safety (MFDS), and Switzerland's Swiss Agency for Therapeutic Products (Swissmedic). These regulatory bodies had achieved WHO’s benchmarking and evaluation process.

A WLA is a regulatory body or regional regulatory system that has been recognized for meeting all the criteria set WHO. This acknowledgement is granted after a thorough assessment using established benchmarks and performance evaluations specific to the requested listing scope.

The TAG-WLA convened for the first time on September 11, 2023, at the WHO headquarters in Geneva, Switzerland. Following discussions on the performance evaluations of HSA, MFDS, and Swissmedic, a consensus was reached to recommend these additions to their listing, marking a significant milestone for these markets.

This designation and public listing of MFDS, HSA, and Swissmedic as WLAs signify global recognition for the Republic of Korea, Singapore, and Switzerland. It attests that these regulatory authorities meet WHO and other internationally recognized standards and practices, underscoring their commitment to ensuring the safety, efficacy, and quality of medical products.

The WLA Framework is designed to enhance access to safe medical products and optimize resource utilization. It enables regulatory authorities, the WHO Prequalification Program, and procurement agencies to rely on trusted agencies' decisions. For pharmaceutical manufacturers, being included in the WHO list is strategically important. It serves as a valuable reference for local health authorities, streamlining the registration process and saving time.

In pharmaceutical regulatory registration, manufacturers typically register their products in reference markets. The addition of Singapore and South Korea to the WHO list now allows manufacturers to attain reference market status by registering in these nations. This presents a more efficient alternative to the traditionally preferred reference markets, such as the USA and EU.

For companies like DKSH, which has a regulatory team based in Singapore and South Korea, there is an increased potential for manufacturers to choose them for Regulatory Affairs Value-Added Services (RA VAS). This shift is particularly notable as before the landmark WHO ruling, the USA and EU were the preferred reference markets despite their longer registration timelines.

The new solution allows manufacturers to initiate their registration process in Singapore and South Korea, benefiting from a shorter timeline while concurrently awaiting approvals from the USA and EU. This strategic approach addresses the challenges associated with lengthy registration timelines in the preferred reference countries, offering a more streamlined and efficient pathway for manufacturers in the regulatory landscape.

The recognition of the HSA in Singapore and the MFDS in the Republic of Korea as WHO-Listed Authorities represents a significant step towards global regulatory alignment. This demonstrates their dedication to international standards and simplifies the registration process for pharmaceutical manufacturers, fostering efficiency and creating new opportunities. This advancement improves global accessibility and safety for medical products, paving the way for companies like DKSH to provide valuable Regulatory Affairs Value-Added Services (RA VAS) in this evolving landscape within the corporate sector.