THE National Assembly will this week be expected to discuss and ratify an agreement to establish a continental medicines regulatory authority in Namibia.
The agency to be known as the African Medicines Agency (AMA) is aimed at strengthening the capacity of medical products regulation in Africa and the harmonisation of regulatory systems, “as a foundation for the establishment of a single medicines regulatory agency in Africa”.
The agency to be hosted by Namibia will also be expected to address the trading of substandard and fake medical products on the continent.
Minister of Health and Social Services Kalumbi Shangula who tabled the motion to ratify the agreement in the National Assembly last week said the treaty to establish the continental medicines agency in Namibia was conceived at the first African ministers of health meeting in Angola in 2014.
That meeting which was organised by the African Union Commission (AUC) and the World Health Organisation (WHO) at the time requested member states to prioritise investment for regulatory capacity development, to pursue efforts towards convergence and harmonisation of medical products regulation in regional economic communities, Shangula said.
So far, the minister said 17 countries have signed the treaty but only two have ratified it.
The treaty needs to be ratified by at least 15 countries before it can be enforced. When established, the agency will be tasked with improving the capacity to regulate medicines, medical products and medical technologies by member states.
Shangula said the agency will also coordinate ongoing regulatory systems; provide regulatory guidance; enhance collaboration; and contribute to improving patients’ access to quality, safe and efficacious medical products and health technologies on the continent.
“The agency offers a continental focus for certain activities, such as the opportunity to assess special classes of medicines for example advanced therapies, active pharmaceutical ingredients and products that are not regulated in many African countries, among them invitro diagnostic products and devices and vector control products,” Shangula said.
He added that the continental agency will collaborate with regional economic communities and national medicines regulatory authorities in the identification of substandard and falsified medical products and facilitate information sharing across countries.
“It is envisaged that the agency will improve the environment for legitimate manufacturers to flourish and improve local manufacturing of quality products. … . [it] is also expected to play a key role, working closely with the WHO on the evaluation of and oversight for the use of medical countermeasures for public health emergencies,” Shangula said.
According to the minister, the agency will further play a critical role in catalysing trade in support of the African Continental Free Trade Area.