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.
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