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East African Community partner states have embarked on a collective Medicines Regulatory Harmonization (EAC-MRH) programme which seeks is to improve access to safe and quality medicine.
Ministry of Health officials say that these efforts will be achieved through harmonising medicines regulation systems and procedures in accordance with national as well as international policies and standards.
A policy document on the programme indicates its objectives as; developing a common technical document for registration of medicines, common information management system (IMS) for the registration, a quality management system in each national medicines regulatory authority; and building regional and national capacity to implement the programme.
The EAC bloc is also working to create a platform for information sharing on the harmonised registration system to key stakeholders, and developing and implementing a framework for mutual recognition of regulatory decisions based on Article 118 of the EAC Treaty.
According to Joseph Kabatende head of pharmaceutical services in the ministry of health, in Rwanda, registration is performed by the pharmaceutical services under the Ministry of Health, where a set of requirements are established.
“Medicines regulation is the whole process of making sure that a medicine that comes into Rwanda complies with the national laws, guidelines and quality and safety requirements,” says Kabatende.
Last month, parliament passed a bill establishing the Rwanda Food and Medicines Authority (RFMA), a new agency that will, among others things ensure that fortified foods like cereals and milk products, as well as food supplements on the local market, meet national and international standards.
According to Kabatende, a quality control laboratory will soon be completed which will help in judgment of whether imported pharmaceutical products are of acceptable quality or not.
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