Regional drug regulation authority in the offing

Regional healthcare stakeholders are pondering the creation of a regional drug regulation authority. The setting up of a regional drug regulator, according to stakeholders, will help curb the distribution of counterfeit and substandard medicines across the region. The stakeholders have been meeting in Kigali for the last two days, under the East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme. “A team of regional experts will be tasked with ensuring that medicines meet standards before arrival on market,” said Dr Stanley Sonoiya, the principal health officer at the East African Community Secretariat. According to the officials, by harmonising regulation systems in line with national and international best practices, improved access to safe and good quality medicines will be guaranteed. The development, if fully implemented, will provide for joint licensing of local drug manufacturers, importers and drug selling points. “The idea is to not only promote home bred drug manufacturers, but also ensure high standards, a move we believe will discourage drug importation,” Sonoiya said at the closure of the meeting yesterday. The first phase of the programme which started in 2012 and ended December last year, saw the creation of guidelines for manufacturing, registration, and evaluation of medicines. The second phase, which ensures smooth domestication and implementation of the guidelines, started in January. “From now onwards, interested applicants may apply for marketing authorisation for their medicinal products,” said Hiiti B. Sillo, the Director General of Tanzania Food and Drugs Authority, who is also the chairman of EAC-MRH. By September last year, Rwanda had linked all 42 district hospitals, 30 district pharmacies, five referral hospitals and over 400 health centres to the electronic drug distribution system(eLMIS), replacing the paper based method previously used. “This online system has greatly worked for Rwanda and this gives other member countries an opportunity to study the system, and possibly introduce similar ones back home,” Sonoiya said. Challenges Fred Siyoi, the deputy registrar of the Pharmacy and Poisons Board, Kenya, however, cited existing skills gaps in the region as the challenge to the implementation of the project (EAC-MRH). He said the region doesn’t have adequate laboratories to test imported (or locally made) medicines, which makes confirmation of their authenticity hard. Furthermore, some member countries, such as Rwanda and Burundi, are yet to establish National Drug Regulatory Authorities. In a related development, regional healthcare players are currently assessing the feasibility of harmonising the various national health insurance systems, as part of the East African Community integration agenda. The move, if successful, would see citizens of the five partner states (Burundi, Kenya, Tanzania, Uganda and Rwanda) get health care anywhere in the region under a uniform billing system.

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Regional drug regulation authority in the offing