PPB, US FDA forge alliance for stronger pharmaceutical regulations

KENYA — The Pharmacy and Poisons Board has signed a commitment agreement with the US Food and Drug Association (FDA), marking a significant step towards strengthening the collaborative efforts between the two regulatory bodies.

This important revelation came after a delegation from the US FDA visited the Ministry of Health, where they were received by Dr. Patrick Amoth, the Acting Director General of Health, on behalf of Health Cabinet Secretary Nakhumicha S. Wafula.

Notably, this event follows a confidentiality agreement signed between the Pharmacy and Poisons Board (PPB) and the US FDA in March 2024.

This earlier agreement aimed to foster new opportunities for cooperative engagement in the pharmaceutical sector.

Consequently, the recent event saw the signing of a Statement of Commitment, during which Mark Abdoo, the Associate Director for Global Policy and Strategy at the US FDA, and Ahmed Mohamed, PPB’s Director of Health Products and Technologies, formalized the agreement.

During the signing ceremony, Dr. Amoth emphasized the importance of securing health commodities, highlighting Kenya’s promotion of local manufacturing.

This initiative includes the establishment of the Kenya Biovax Institute and substantial support for the PPB.

He explained that these efforts are part of Kenya’s strategy to achieve WHO Maturity Level 3 (ML3) status as a National Regulatory Authority (NRA).

According to Dr. Amoth, achieving WHO-ML3 status offers significant benefits for both local manufacturers and importers of medical products. These benefits include simplified approval processes and enhanced transparency.

Moreover, Dr. Amoth elaborated on the broader implications of the agreement. He noted that it will streamline regulatory processes to facilitate business and local manufacturing.

This streamlining is expected to ensure efficient market access for commodities and improve access to affordable, cost-effective medical products.

Aligning regulatory practices between Kenya and the US FDA will thus contribute to a more robust pharmaceutical sector in Kenya.

In addition, Dr. Amoth pointed out that local pharmaceutical manufacturers are particularly supported by tax-free importation of active pharmaceutical ingredients (APIs) and equipment necessary to produce high-quality medicines.

This policy is designed to bolster the capacity of local manufacturers, thereby enhancing the overall quality and availability of medicines in the country.

Furthermore, the commitment between the PPB and the US FDA represents a significant step in international cooperation.

It underscores the importance of global partnerships in addressing public health challenges and enhancing the regulatory frameworks that govern the pharmaceutical industry.

Through such collaborations, both regulatory bodies aim to improve the safety, efficacy, and quality of medical products available to the public.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook