ISO 9001: 2015 CERTIFIED

PUBLIC NOTICE

19^th August, 2021

SIGNING OF THE TREATY FOR THE ESTABLISHMENT OF THE AFRICAN MEDICINES AGENCY – AMA

1. On 10th August, 2021 at the African Union Headquarters in Addis Ababa, Ethiopia, Her Excellency Ambassador Liberata Mulamula (MP), the Minister of Foreign Affairs and East African Cooperation, officially signed the Treaty for the Establishment of the African Medicines Agency (AMA).
2. The event was witnessed by the Deputy Chairperson of the African Union Commission, Dr. Monique Nsanzabaganwa, Acting Ambassador of the United Republic of Tanzania in Ethiopia, Ms. Elizabeth Rwitunga, and Director of Africa Department in the Ministry of Foreign Affairs and East African Cooperation, H.E. Ambassador Naimi S. Azizi. Others were Director General of TMDA, Mr. Adam Fimbo, officials from the Ministry of Foreign Affairs and East African Cooperation and Mr. Merick Luvinga, Director of Legal Services from the Ministry of Health, Community Development, Gender, Elderly and Children.
3. The aim of this Treaty is to establish an Agency to regulate and facilitate access to quality, safe and effective medicines in Africa.
4. The Treaty will promote efforts to harmonize medicines regulatory requirements in Africa under the New Partnership for Africa's Development (NEPAD), adopted by the African Union Declaration. Assembly / AV / Dec.55 (IV).
5. The Treaty was adopted by the Heads of State and Government of the African Union at the 32nd Summit held in Addis Ababa, Ethiopia on February 11, 2019.
6. So far 22 countries have signed the Treaty out of which 11 to include Algeria, Rwanda, Namibia, Seychelles, Sierra Leone, Niger, Burkina Faso, Ghana, Guinea, Mali and Benin have already ratified the Treaty.
7. The expected benefits after ratifying this Treaty, will be as follows: -

   7.1 Combined efforts in the fight against substandard and falsified medical products across the porous borders of member states. WHO's 2017 figures show that the problem of falsified medicines in Africa has reached 10%.

   7.2 Promotion of domestic pharmaceutical industry through creating enabling environment for marketing authorization of medicines in member countries as regulatory systems will be harmonized.

   7.3 Streamlining regulatory processes within the EAC and SADC regions and facilitate manufacturers to submit harmonized information on registration of products to all member states.

   7.4 Facilitating trade between member states in line with the African Continental Free Trade Area and ensure availability of medicines in case of public health emergencies.

8. After signing, the next step will be to table the bill to the Parliament for ratification of the Treaty.
9. The Tanzania Medicines and Medical Devices Authority, will cooperate with AMA when discharging its functions after ratification.