Arusha. The East African Community (EAC) medicines regulatory harmonization project aims to increase access to medicines and health care products that are affordable and of good quality, it has been said.
The products should also be safe and efficacious for all diseases and conditions, resulting in the prevention of diseases and better treatment of illness to protect and promote a healthy population in the region.
This was stressed during at a two-day EAC regional stakeholders’ consultation meeting to validate technical documents that the Partner States National Medicines Regulatory Authorities (NMRAs) will use for harmonized medicines regulation scheme.
The EAC documents that were validated include Guidelines, Manuals and Standards to be used in the joint registration and evaluation of medicines for marketing authorization, joint good manufacturing practices (GMP) and inspections for pharmaceutical manufacturing facilities.
Others are regulatory information exchange and quality management system requirements for Partner States NMRAs to ensure that adequate quality standards are maintained, so as to achieve consistency in regulatory service delivery and facilitate mutual trust, confidence and recognition.
Addressing the meeting, the EAC deputy secretary general (Productive and Social Sectors) Ms Jessica Eriyo noted that one of the key interventions for the East African Medicines Regulatory Harmonization (EAC-MRH) Framework is to facilitate the process of good health of the people, free movement of goods and services, developing industries and the private sector to transact in fair and better trade.
“The public have to participate in the integration process. Medicines regulatory harmonization is key in facilitating proper handling and use of medicines to ensure a healthy and productive population.
“The integration has to be people-centered and private-sector-led to ensure that the people benefit and build capacity in the region. The borders are porous meaning that goods can be smuggled from one country to another, resulting in unfair trade and poor quality goods,” she said.
The Heads of the National Medicines Regulatory Authorities (NMRAs) assured delegates of their continued commitment and support to the medicines regulatory harmonization process that aims to strengthen existing NMRAs and transform them into Centres of Excellence (CoE) for regulatory capacity building programmes.
The Executive Director of Community Health and Information Network (CHAIN Uganda) and Chairperson of Uganda Alliance of Patient Organization (UAPO), Ms. Regina Kamoga underscored the need to meaningfully involve health consumers and patients at all level of decision making to ensure that decisions are designed with the consumer/patient at the center.
The Development Partners congratulated the EAC Secretariat and Partner States for the milestone so far achieved in streamlining medicines regulation procedures that will contribute to improvement of health outcomes, facilitate trade and development of pharmaceutical industries.
The meeting drew participants from both public and private sector in the five Partner States that included representatives of the respective Ministries of Health, Commerce, Trade, Industry and EAC Affairs, regional and international Pharmaceutical Manufacturers, National Bureaus of Standards, Consumer Protection Organizations and National Medicines Regulatory Authorities.