Delese Mimi Darko, CEO, Food and Drugs Authority (FDA): Interview

Interview: Delese Mimi Darko

What was the role of the FDA in the approval process for Covid-19 vaccines?

DELESE MIMI DARKO: The FDA, as a regulatory agency, is responsible for ensuring the quality, safety and efficacy of all food, drugs and medical products available in Ghana, including vaccines. During emergency situations like the Covid-19 pandemic, national medicines regulatory agencies have a responsibility to evolve their measures to ensure speedy approval of relevant products, including vaccines for the sake of public health. This is done without compromising quality and safety by going through the established protocols.

In the case of Ghana, the FDA adhered to protocols by completing a full review of the six available Covid-19 vaccines as of late 2021. The FDA operates at Maturity Level 3, which means it has the resources in place to do a full review of any vaccine to ensure its safety. Ghana is also a member of the African Vaccine Regulatory Forum, which is a network of national regulatory bodies with an ethics committee that harmonises regulatory processes, including for vaccine reviews. This centralised and collaborative body guided the FDA and helped streamline Covid-19 vaccine approvals in Ghana.

To what extent are counterfeit pharmaceuticals a concern in the country, and how is the FDA working to address this challenge?

DARKO: Ghana has its fair share of the global problem of sub-standard and falsified medicines, but the FDA has several measures in place to address this. We conduct pre-evaluation tests before a product is placed on the market, and we continue to monitor the quality of products once they are available to the public. The FDA conducts market surveillance through regional offices and posts at major ports of entry and selected land border crossings. The authority uses rapid-testing devices and mini labs to perform quick evaluations, and subsequent confirmatory tests are done in the main laboratory at the FDA head office in Accra.

As it is not practical to test every product that enters the market, the FDA relies on a pharmacovigilance system that employs a risk-based approach for sampling and testing. With this system, the authority receives complaints from health care professionals and the public and investigates the product in question, taking appropriate regulatory actions where required. Our safety-monitoring programme, which is one of the best on the continent, has been certified as Maturity Level 4 by the World Health Organisation.

The FDA works closely with other government agencies to tackle the issue of counterfeit pharmaceuticals, including those involved in security, law enforcement and criminal investigations. We cooperate with our counterparts throughout the ECOWAS region as well.

How can companies take advantage of the opportunities presented by the launch of the African Continental Free Trade Area (AfCFTA)?

DARKO: The AfCFTA presents an array of opportunities for Ghana given that the country has many strong local companies, especially in the pharmaceuticals industry. The FDA continues to work closely with the domestic manufacturing companies that it regulates to ensure adherence to quality and safety standards while boosting the competitiveness of local products. The AfCFTA provides a continental market for medicines made in Ghana, and serves as an incentive for large-scale production and trade.

In view of the open market, we are working with the Investment Promotion Council to ensure a safety-sensitive regulatory environment for trade. The FDA has therefore established a Centre for Import and Export Control that works across borders to help monitor products that enter and exit the country. It is through these measures that the FDA is working to ensure that whatever is imported to or exported from Ghana meets the required quality and safety standards as we contribute to the development goals of the AfCFTA.