East African Community partner states have embarked on a collective Medicines Regulatory Harmonisation (EAC-MRH) programme which seeks is to improve access to safe, efficacious and quality medicines by the bloc’s citizenry.
This will be through harmonising medicines regulation systems and procedures in accordance with national as well as international policies and standards, according to an official who attended a recent meeting that discussed the issue extensively.
A policy document on the programme indicates its objectives as including 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 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.
In Rwanda, registration is currently performed by the pharmaceutical services under the Ministry of Health, where a set of requirements are established and any applicant for pre-market approval is required to comply with requirements, says Joseph Kabatende, the head of pharmaceutical services in the ministry.
“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,” said Kabatende.
Early last month, parliament passed a bill establishing the Rwanda Food and Medicines Authority (RFMA), a new agency that will, among others, ensure that fortified foods like cereals and milk products, as well as food supplements on the local market, meet national and international standards.
The RFMA will also inspect and verify food and pharmaceutical products.
Current challenges, according to Kabatende, include the fact that “performing both policy functions and regulatory functions requires a lot of both financial and human resources.”
“We have been stretched while performing these functions with few human resources in addition to the lack of means like equipment, especially for inspections like mini-labs, vehicles for inspection, and others.”
Apart from the gap that is soon going to be covered by the RMFA, Kabatende said, another challenge has been the absence of a quality control laboratory to regularly test the quality of imported pharmaceuticals because Rwanda, like its peers in the EAC, imports its medicines.
However, by year end, Kabatende said, “a quality control laboratory will be completed which will help us ascertain the quality of imported pharmaceutical products.”
The EAC-MRH project that is underway, Kabatende said, will not only address the issue of delays but also improve efficiency and quality services.
In Uganda, the National Drug Authority (NDA), a semi-autonomous government body, in mandated to guarantee the availability, at all times, of essential, efficacious and cost-effective drugs to the population of Uganda. It regulates all human and veterinary medicines entering Uganda.
Peter Ssali, the head of quality management at NDA, said the regulation of medicines requires a lot of technical and administrative expertise, and financial sustainability if it is to be done effectively.
“This can best be done by a semi-autonomous corporate institution that must enjoy government support and political will,” Ssali said, adding that he acknowledges challenges, including financial sustainability which “can be challenging especially in the initial formative stages.”
He said: “Many times, the most reliable funding is that generated internally in the corporate institution in form of fees for the services rendered. Government support and funding is, therefore, important.”
He is, nevertheless, optimistic that the forthcoming collective regional MRH project will bring more benefits.
“The regional MRH harmonisation is feasible if the five member states continue the commitment to its success and if it is supported by an enabling EAC policy and law. There is quite impressive expertise available within the EAC countries,” Ssali said.
The impact of a regional framework would be quite significant, he said.
EAC’s MRH project was launched in Tanzania in March 2012.
Erwin Wumurenzi, the managing director of QualMED, a pharmacy based in Kigali, said the private players in the industry also stand to benefit once the EAC-MRH project matures.
Wumurenzi said: “There will be easy access to cost effective drugs for importation. It will also improve the process of registering new drugs on our market, due to the availability, then, of data in our sister countries. There will also be expansion of the market.”