IFPMA welcomes announcement of first three regulatory agencies listed under WHO Listed Authorities Framework
On 2 November, IFPMA and its member associations in South Korea, Singapore and Switzerland have welcomed the appointment of the Korean Ministry of Food and Drug Safety (MFDS) of South Korea, the Health Sciences Authority (HSA) of Singapore, and Swissmedic of Switzerland as the first three Listed Authorities under the WHO Listed Authorities (WLA) framework.
The WLA framework gives regulatory authorities operating at an advanced level of performance global recognition. It also facilitates reliance on the work of trusted agencies in the decision-making of regulatory authorities, the WHO Prequalification Programme, and procurement agencies.
According to the WHO, only about 30% of the world’s regulatory authorities have the capacity to ensure medicines, vaccines, and other health products are produced to required standards, work as intended, and do not harm patients. Through the “WHO Listed Authorities Framework,” the WHO has embarked on an ambitious effort to identify regulatory authorities that are operating at an advanced level. This is so that they can act as a reference point for regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight.
The IFPMA and its member associations consider this as an important step in the implementation of the framework, which is intended to promote access and supply of safe, effective, and quality medical products.
Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), said:
“Congratulations to South Korea, Singapore, and Switzerland for being the first authorities listed under the WHO’s Listed Authorities Framework. This important initiative can help strengthen health systems and facilitate equitable access to healthcare products through harmonization, collaboration, and robust regulatory practices. I wish the agencies every success in taking forward their work as part of this initiative.”
Dr. René P. Buholzer, CEO & Delegate of the Board of Interpharma, the association of Switzerland’s research-based pharmaceutical industry, said:
“We are advocating for resilient healthcare with fast access to innovation that puts patients and their needs at the center. Interpharma supports Swissmedic’s ambition to be one of the world’s leading regulatory authorities and we welcome the WHO’s initiative to provide patients worldwide with efficient and safe access to medical innovations.”
Christina Teo, Executive Director of Singapore Association of Pharmaceutical Industries (SAPI), said:
“Congratulations to HSA of Singapore, MFDS of South Korea and Swissmedic of Switzerland on their remarkable achievements as the first three countries to be listed on the WHO’s Listed Regulatory Authorities.
This remarkable accomplishment is a true testament to HSA’s unwavering commitment to regulatory excellence and is met with the highest regard from our industry. By adhering to the WHO standards, HSA not only advances patient safety but also strengthens public health systems, a cause SAPI and its members wholeheartedly support.”
Youngshin Lee, CEO of the Korean Research-based Pharmaceutical Industry Association (KRPIA), said:
“This is an important step for South Korea and we look forward to seeing the implementation of the framework, which has the potential to support health systems strengthening and access to innovative medicines, through regulatory excellence and collaboration.”
About IFPMA
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) represents over 90 innovative pharmaceutical companies and associations around the world. Our industry’s almost three million employees discover, develop, and deliver medicines and vaccines that advance global health. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community improve the lives of people everywhere. For more information, visit ifpma.org.
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