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NAFDAC moves to harmonise medicine registration to meet ECOWAS standard


Enugu  – The National Agency for Food, Drug Administration and Control (NAFDAC) has urged manufacturers and importers of drugs to follow the Medical Registration Harmonisation (MRH) to achieve single medicine evaluation in ECOWAS.

Mr Olakunle Okelola, Regulatory Consultant to NAFDAC, disclosed this at a one-day workshop on “Common Technical Document (CTD) for ECOWAS Member States’’ in Enugu on Wednesday.


“The whole world is moving towards harmonisation of processes.

“Thereby, if a company wants to export (drug) products to other countries, the same system of registration is now going to be used all over West Africa.

“And to be able to do that, we must also present our registration processes in a structure.

“So, this structure is what is called Common Technical Document (CTD).

“So there is a commonality in the way products are being presented to NAFDAC for registration, to food and drug authority of Ghana, to the other regulatory agencies in West Africa.

“But because companies have staff who would prepare these documents to give to NAFDAC, they must learn how to prepare it.’’


Okelola said that the harmonisation would facilitate the acceptability of the country’s drug and its associate-products in the ECOWAS sub-region.

He said that it would help indigenous drug manufacturers to meet standards for international organisation certification as well as business-partnerships.

The consultant said that the 15 ECOWAS member countries had rectified the document in 2015, adding that all member states had started pursuing its operation since February.

The acting Director-General of NAFDAC, Mrs Yetunde Oni, said that the workshop would facilitate drug manufacturers and importers’ ability to meet world standards.

According to her, the manufacturers and exporters should be able to meet standards for the documentation and approval of the products in ECOWAS and globally.

Oni said that the workshop would also aid export of Nigerian medicines and make local manufacturers of drugs tap from the global medicine business.

“It would globalise our indigenous drugs and drug-related products.

“Thus, making Nigeria to benefit from the enormous financial funding and profit in selling its products to the UN, WHO and medical donor agencies.’’

Mr John Ezugwu, Quality Assurance Manager of Juhel Nigeria Ltd., said that the workshop would further aid his company in its drive to export products to some ECOWAS countries.

“We have been longing for business expansion in West Africa and the CTD is a new vista for us to achieve our year-long sought expansion,’’ Ezugwu said. (NAN)

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