African Union (AU) is coming up with an African Medicine Agency (AMA) which will be tasked with cooperation and strengthening of healthcare activities to harmonize medicine regulation of member states of the Union in line with European Medicine Agency (EMA).
There are 55 countries in African Union. In August 2017 AU had come up with draft treaty for the establishment of AMA. Once the draft treaty is ratified by the member states, it will pave the way for setting up of AMA.
The main objective of AMA is to improve access to quality, safe and efficacious medical products on the continent through coordination and strengthening of ongoing initiatives to harmonize medicines regulation, promote cooperation and mutual recognition of regulatory decisions. Besides, it will be carrying out regulatory oversight of selected medical products and providing technical guidance to AU member states and Regional Economic Community (RECs) recognized by AU, pooling expertise and capacities and strengthening networking for optimal use of the limited resources available for regulatory authorities and complement and enhance the efforts of on-going harmonisation initiatives.
At the core, it will serve as a catalyst for stronger regulatory monitoring to check substandard medical products and improve competitiveness of medicines manufactured in AU countries for diseases affecting the African continent.
The AMA will be set up within the framework of a new pact signed between the African Union Commission and the WHO in 2013, and the first meeting of the African Health Ministers jointly held by the two organizations in Luanda, Angola in April 2014.
African countries are not able to utilize healthy populace in economic progress because of low investment in healthcare system. It’s a challenge for a country lacking adequate healthcare resources to regulate its own market in an effective and efficient way.
The AMA as an institution equipped with technical support, expertise in various countries and resources cannot be matched at national or regional level. It will promote good public health practice in member states through capacity building and the promotion of continuous quality improvement in the delivery of medical products regulation. It will support regional regulatory centres which have been selected through African Medicines Regulatory Harmonization Program.
However, AMA will not replace National Medicines Regulatory Authorities (NMRAs) or sub-regional Medicines Regulatory Authorities, which will be set up by the Regional Economic Communities (RECs).
Ten countries – Algeria, Egypt, Kenya, Ivory Coast, Libya, Morocco, Nigeria, South Africa, Sudan, and Tunisia – account for 70 per cent of African pharmaceutical market.
AU’s effort to harmonize regulatory system of member states and build their capacity through AMA, has invoked positive response from Indian pharmaceutical industry which gets half of its annual export revenue from Africa.
“We see minimal impact on the overall Indian pharma exports because in the last five years Africa has witnessed continuous tightening of regulatory norms and stricter audits in line with ICH guidelines. Simultaneously, Indian exporters have also responded by evolving their manufacturing processes to comply with these requirements. The creation of African Medicine Agency is emblematic of the fact that all African countries and their ministries of health will follow international norms and will be subject to global regulatory processes”, said Dr Anwar Daud, managing director, Zim Laboratories which has presence in African countries—Ethiopia, Rwanda and Nigeria. This comprises around 10% of its turnover.
This will have a positive impact on Indian pharmaceutical market in medium to long term as Indian market in general has been in a process of steep regulatory tightening in the domestic and surrounding Asian markets. This makes India better equipped as vendors than the mushrooming local companies in Africa and the recently emerging low-cost competitors to India such as manufacturers from South East Asia, CIS, China, Bangladesh, Pakistan, Vietnam, Kazakhstan, Egypt etc, he said.
Dr. Piyush Gupta, associate director, GNH India said “Regulatory harmonisation in African continent is a welcome step. It will have positive impact on India's export in Africa as it will strengthen India's regulatory compliance in African countries. It will do away with the need of registration for certain life saving drugs in every member state of AU. Once the product gets regulatory approval in a member state, it can be distributed to other states as well. It will further boost India’s export in Africa.”