BURKINABE REGULATORS PAY A WORKING VISIT TO FDA GHANA.

The Food and Drugs Authority (FDA) has held a training from 2nd to 5th March 2020, for a two member delegation from the Nationale de Regulationa Pharmaceutique (ANPR) du Burkina Faso, who paid a four day working visit with the purpose of understudying the work of the Authority.

The Burkinabe regulators with a background in drug registration are Pharmacists known as Monsieur Coulibaly Yaro Moithien and Madam Bationo Hetie Sounougou. They visited with the intention of understudying the work of FDA Ghana in comparison to theirs Regulatory body and hoped to be trained on the Authority's Drug Registration and Clinical Trial process, specifically how samples and documents are stored and how safety disposals are conducted.

Mr. Seth Seaneke, the Acting Deputy Chief Executive Officer (DCE) for the Drug Registration and Inspectorate Division, welcomed the delegates to Ghana on behalf of the CEO, Mrs. Delese Darko. He briefed in on the overview of the Authority activities and Organizational structure. Furthermore he probed to find out the Burkinabe regulators expectation in order to ensure that it is tailored into their training activity.

During the four day training, a team of five FDA officials was put together to assist the Burkinabe regulators on the Authority's clinical trials oversight and drug registration process which includes how applications are submitted and classified; how samples are processed and assessed at the FDA accredited laboratory and how dossiers and samples are kept all to when approval is received.

However, due to their registration background, the Burkinabe regulators were given additional information on guidelines that are applicable in processing applications. Also, they were taken through product information, a key aspect in registration process because as a regulator, it is part of your mandate to inform the public on the labelled information, patient information leaflet and the information for prescribers so that they understand the usage of a drug. In addition the regulators were given some examples to appreciate the registration processes better.

Monsieur Coulibaly Yaro Moithien, the leader of the delegation at the end of the training said, they have learnt a lot, right from receiving to sorting out data and document. He spoke on the availability of a detailed guideline which help clients in registration. He commended the work of the FDA and said everything is well documented which is different from what is practiced in their regulatory body, hence they would inculcate the work of the FDA when they get back to Burkina Faso.

Furthermore, he mentioned that FDA Ghana is well organised and has qualified officials strictly following the set guidelines and necessary protocols needed to ensure that the mandate of the Authority is fulfilled. He said, from their observation whatever result the FDA produce is authentic and trustworthy.