FDA revises Guidelines to conform to international best practices

The Food and Drugs Authority (FDA) said it has revised its guidelines to conform to current international best practices, with respect to medicines registration towards the use of Common Technical Document (CTD).

The use of the CTD for the registration of medicines is bridging the gap of misunderstanding that used to be pronounced between manufacturing and regulators, to ensure transparency in medicines registration.

Addressing a training programme for Managers and Regulatory Contact Persons of Pharmaceutical Companies on the Revised FDA guidelines, Deputy Chief Executive (Food Safety Division) on Friday, Mr John Odame-Darkwah said the new guidelines would ensure faster access to quality, safe and efficacious medicines to the population.

“Medicines are not mere articles of commerce. Therefore what goes into it from time of idea conception until the finished pharmaceutical product is put on the market should have standardized procedures and processes.”

This also assures the manufacturer, distributor and consumer that the product is the right quality, safe and efficacious which are what the regulator seeks to ensure.

The training, he noted, had become necessary with knowledge on medicines regulation front changing across the world, adding that regulators need to take a look at the current trends, International best regulatory practices and pertaining situations and transform.

“The CTD in medicines registration is promoting regulation harmonization all over the world, and making it easier for manufacturers to put their medicinal products on the market several countries at the same time”.

Mr Seth Seaneke, Acting Head of Drug Registration and Registration, said the responsibility of the department was to oversee the FDA’s regulatory activities, with respect to medicine registration, to ensure access to quality, safe and efficacious medicines in the health delivery system. GNA

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