FDA adopts new guidelines for medicine registration

The Food and Drugs Authority (FDA) has adopted new guidelines with respect to medicine registration to conform to current international standards.

A two-day training workshop to sensitise the stakeholders of the authority on new trends in medicine regulation has been organised to educate them.  

The workshop brought together manufacturers and exporters of allopathic (foreign) medicines.

Some of the guidelines which were discussed included revised bioequivalence guidelines, stability studies and new variation guidelines.

Speaking at the opening ceremony, the Deputy Chief Executive of the FDA in charge of the Food Safety Division, Mr John Odame Darkwah, said medicine regulation was continually changing, hence the need for the FDA to adopt current trends and best international practices.

Bridging the gap

He said the FDA had adopted the Common Technical Document (CTD), which sought to bridge the gap of misunderstanding of medicine registration between manufacturers and regulators.

By the document, Mr Darkwah said, medicine regulation was expected to harmonise all over the world to make it easier for manufacturers to put their medicinal products on any markets around the world. 

Therefore, he said, it was necessary for stakeholders to be abreast of the new and revised guidelines for medicine registration based on the CTD to ensure transparency.

He urged the participants to actively participate in the training, so that their medicinal application submissions would be in line with the FDA’s, as well as international, standards. 

In his presentation, the Head of Drug Evaluation and Registration at the FDA, Mr Seth Seaneke, said the key requirements in medicine registration were quality, safety and efficacy.