FDA Explains Drug Registration Process

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By Cecil Mensah

The Food and Drugs Authority (FDA), the agency tasked to regulate the manufacturing and distribution of food and drugs in the country, has said that a product registered by the authority can have its registration cancelled, should the manufacturer or distributor fail to put the product on the market after a year.

Seth Seaneke, the Deputy Chief Executive (DCE), made this revelation on the legal mandate of the authority to cancel registration of products at a stakeholders’ training workshop on the new and revised guidelines for registration of Allopathathic medicines in Accra.

According to him, section 117 of the Public Health Act 2012, talks about applications and their prescribed fees, while section 118 sub-
sections 6, gives distributors and manufacturers the opportunity to appeal against registration decisions within sixty days.

He said, the legal mandate of the authority is premised on section 147, where the Minister of Health in consultation with the FDA, presents Legislative Instrument (LI) prescribing fees for services rendered.

He continued that section 148, also mandates the FDA to issue guidelines and core practices with respect to the registration of drugs.

He mentioned the types of registration as, new medicinal drug applications, renewal, variation applications, fresh application (new drugs representing three percent) and fresh applications (genetic) presenting about ninety- seven percent).

He mentioned departments such as, Drug Evaluation and Registration, Drug Enforcement, Herbal Medicines, Pharmaceutical Industrial Support and Tobacco and Substance of Abuse as the five departments responsible for the Drugs Registration and Inspectorate.

He outlined the key areas of registration as submission of application, application review, GMP audit, quality control analysis and marketing authorization before registration, approval, differed and rejected.

He said, the registration is centered on quality, safety and efficacy for generic pharmaceutical products with safety and efficacy data reduced to demonstrating bioequivalence if necessary.

On his part, Alhaji Hudu Mogtari, Chief Executive Officer (CEO) said, the knowledge on the medicines regulation front is continual changing with time all over the world now since regulators have to look at current trends and international best regulatory practices.

He said, the FDA in the last few years, has revised its guidelines to conform to current international best practices with respect to medicines registration towards the use of the Common Technical Document (CTD).

He explained that the use of the CTD for registration of medicines is bridging the gap of misunderstanding that used to be pronounced between manufacturers and regulators and ensures transparency in medicines registration, adding this ensures faster access to quality, safe and efficacious medicines worldwide.

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