World Bank funds East Africa medicine law harmonisation
The US$5.5 million project aims to help harmonise the pharmaceutical regulations of the five East African Community countries of Burundi, Kenya, Rwanda, Tanzania and Uganda
The World Bank is funding a US$5.5 million project to help harmonise the pharmaceutical regulations of the five countries within the East African Community (EAC): namely, Burundi, Kenya, Rwanda, Tanzania and Uganda.
Under the Bank’s schedule, the African Medicine Regulatory Harmonisation Project should be completed by December 2014. Four regional technical working groups (TWGs) have been established and are undertaking detailed tasks on drafting common technical documents for medicine registration; good manufacturing practice inspection; information management systems; and quality management systems. These groups are now having regular exchanges through video conferencing and face-to-face meetings with technical support from the World Health Organisation (WHO). All these groups have made good progress and draft guidelines are now available.
The project is being jointly implemented by the EAC and its member states. The community has also signed a memorandum of understanding (MOU) with the WHO over receiving relevant technical assistance.
There have, however, been delays associated with the project which was approved in October 2011, with EAC member states taking time to recruit project staff; national medicine regulation officers were finally appointed in March and started working from April.
EAC national medical regulatory authorities have now finalised a draft common technical document regarding regulatory harmonisation for medicine registration. This has been based on internationally recognised policies and standards, said the World Bank. Training and piloting of these systems will start in the first quarter of 2014.
