By Victoria Hanson, LAGOS
The West African Health Organization, WAHO, is organizing training for Local Medicines Manufacturers on the use of the ECOWAS Harmonized Common Technical Document (CTD) for Medicines Registration.
The three-day training holding at Radisson Hotel, Lagos, Nigeria, targets a first batch of local manufacturers located in the ECOWAS region.
Recall that in 2010, WAHO under the leadership of the ECOWAS Commission developed Common Technical Documents (CTD) with the aim of harmonizing the requirements for registration of medicines in West Africa.
Speaking at the opening on Wednesday, 22 March, 2019, the Professional Officer in Charge, Essential Medicines and Vaccines at WAHO, Mrs. Sybil Ossei-Agyeman-Yeboah, said the Director General of WAHO, Prof Stanley Okolo, is committed to ensuring qualitative, safe and affordable medicines across West Africa.
While stressing the importance of the capacity training, she noted that participants drawn from pharmaceutical industry in Nigeria should follow the procedure that is being laid down for registration of pharmaceutical products for human use.
Mrs Ossei-Agyeman-Yeboah, said “A common technical document has been developed and we want to ensure that every member state use the same document across the region.
“The issue is not just about counterfeit or falsified medicines, the issue is about quality, safe and accessible medicines.”
Also speaking, the President of West African Pharmaceuticals Manufacturers Association, WAPMA, Dr. Okey Akpa, commended WAHO for organizing the training as a way of moving the industry forward in the region.
He however, charged WAHO to come up with a deliberate effort to encourage access to market since once quality and safe medicines are manufactured there must be ready market.
According to him, access to market must be a critical component of whatever the organization is doing to encourage production of quality medicines by local manufacturers in West Africa.
The three-day training is being attended by 60 Regulatory Affairs and Production Managers and staff of Medicines manufacturers in the region.
At the end of the training, participants are expected to be familiar with the framework for medicines registration application in the CTD format is known; he contents of the different modules of the CTD and their contents are known; as well as the requirements by NMRAs for the preparation of Medicines dossiers.