FDA, stakeholders review requirements for registration of herbal medicine

No herbal medicinal product in the country has been able to go through the Food and Drugs Authority (FDA) clinical trial required to ascertain the efficacy of herbal preparation for the treatment of chronic diseases in the last five years.

Consequently, the FDA is reviewing and exploring the possibility of using other proven laboratory models to access the efficacy of those products.

The Chief Executive Officer of the FDA, Mrs Delese Mimi Darko, disclosed this at a stakeholders meeting in Accra yesterday to review documentation requirements for registration of herbal medicinal products.

Stringent control

Mrs Darko explained that the decision to demand stringent control of the registration by way of evidence of efficacy and safety of herbal medicines, though painful to the industry, had been helpful to its development over the years.

She said the FDA was committed to assisting the herbal industry to come up with products that could be competitive globally, thereby creating wealth for the industry players and the country as a whole.

“The FDA is consequently beefing up the capacities of the herbal testing unit of the Laboratory Services Department of the FDA to a Research Unit,” Mrs Darko announced.
She said the Safety Monitoring Department would also guide the industry to monitor the safety of their products.

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Referring to advertisement of herbal medicinal products, Mrs Darko said, “The authority demands that FDA guidelines on adverts be strictly adhered to and failure to do so could lead to the withdrawal of product market authorisation.”

She said advertisers of food and herbal products were required to clear with the FDA before going ahead to advertise.

Post market surveillance

Mrs Darko reminded producers and manufacturers who sought clearance from the FDA for labels to keep to that and reverse to the authority for alteration if they deemed it fit.

She said the post-market surveillance activities of the authority had shown that product labels on the market differed from that presented for registration.

“It is my firm belief that you, our stakeholders, will rally around the regulatory activities of the authority to ensure that products we put on the market are of good quality efficacious and safe to the consumers,” she advised.

Herbal market

Taking the stakeholders through a presentation on “Additional documentation requirements for registration of herbal medicinal products,” the Head of Herbal Medicine Department of FDA, Mr Emmanuel Yaw Kwarteng, explained that it was the prayer of the authority that “you get to a level where your products could be competitive globally.”

He told the stakeholders that there was a big opportunity in the United States and the European markets and advised them to take pains to do the right thing.