Namibia urged to endorse African medicine

By Maria Kandjungu

THE Minister of Health and Social Services Dr. Kalumbi Shangula has called on the National Assembly to endorse the establishment of the African Medicines Agency (AMA) that will allow African countries to regulate medicines, medical products and medical technologies.

Shangula who made the call on Tuesday when he tabled the motion to ratify the treaty for the establishment of AMA, noted that with regards to Covid-19, AMA is the ideal body to assess the pandemic organics offered by Madagascar and make recommendations that would assist African states to make an informed decision on the product.

The treaty to establish AMA was endorsed by the AU Summit in February 2019 and requires ratification by a minimum of 15 countries before it comes into force.  Thus far 17 countries according to Shangula have signed the treaty but only two have ratified it.

According to the health minister, the agency aims to coordinate ongoing regulatory systems; strengthen and harmonise efforts of the African Union-recognised Regional Economic Communities, Regional Harmonisation Organizations and Member States; provide regulatory guidance and finally complement and enhance collaboration and contribute to improving patients’ access to quality, safe and efficacious medical products and health technologies on the continent.

“Since the Regional Economic Communities are at different levels of implementation of regional harmonisation initiatives, AMA will offer the opportunity for a continental focus for certain activities, such as the opportunity to assess special classes of medicines, pharmaceutical ingredients and products that are currently not regulated in many African countries,” Shangula said.

He added that Africa faces a major problem with substandard and falsified medical products, a continental problem that cannot be addressed by individual countries.  AMA will collaborate with Regional Economic Communities and the National Medicines Regulatory Authorities in the identification of substandard and falsified medical products and facilitate information sharing across countries.

It will also provide a better environment for legitimate manufacturers to flourish and improve local manufacturing of quality products.

He added the AMA will be working closely with the World Health Organisation on the evaluation and oversight of the use of medical countermeasures for public health emergencies. It will also leverage the best expertise available within National Medicines Regulatory Authorities across Africa and will offer recommendations based on sound scientific assessments, evaluations and inspections that Regional Economic Communities initiatives’ and National Medicines Regulatory Authorities can rely on to make regulatory decisions.

“AMA offers an opportunity to catalyse support from countries and undertake certain activities more efficiently, while at the same time consolidating the Regional Economic Communities initiatives, especially in many countries where the National Medicines Regulatory Authorities are critically understaffed to inspect the hundreds of manufacturing facilities making medicines and vaccines and to maintain required vigilance over time,” said Shangula.

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