HARMONIZATION INITIATIVES

TMDA laboratory is a member of various regional harmonization initiatives which facilitates collaboration with other member states to regulate pharmaceuticals, medical devices, diagnostics, disinfectant and antiseptic products. These programs are important since such type of products have no boundaries particularly for countries located within the same region.

Advantages of these initiatives are:

  • Improved efficiency of regulatory processes;
  • Harmonized standards are implemented and respected by participating regulatory authorities and thus building confidence and/or reliance among them;
  • It facilitates trade activities and create common market among the member states; and
  • Enables capacity building and sharing of knowledge on regulatory functions.

TMDA Quality Control laboratory is a member of African Society for Laboratory Medicine (ASLM) and African Medicine Quality Forum (AMQF), an overview is provided below:

1. African Society for Laboratory Medicine

The African Society for Laboratory Medicine (ASLM) is an international organisation founded in March 2011 in Addis Ababa, Ethiopia. The ASLM coordinates, galvanises and mobilises relevant stakeholders at the local, national, and international levels to improve local access to world-class diagnostic services and ensure healthy African communities at present and in the long-term.

Mission and Goals of ASLM

Mission for ASLM is to improve clinical and public health outcomes in Africa by enhancing professional laboratory practice, science and networks. ASLM goals are:

  1. Building Africa’s laboratory medicine workforce to meet growing health priorities;
  2. Strengthening the quality of laboratories workforce across the continent;
  3. Ensuring access to safe medical diagnostic products in Africa; and
  4. Building laboratory networks for better disease detection and access to testing services.

Based on the partnership and network centred approach, ASLM works on the following five functional pillars:

  • Laboratory Networks: Strengthen laboratory networks and systems to support the delivery of clinical and public health functions.
  • Laboratory Workforce: Strengthen the laboratory workforce in Africa.
  • Quality of Laboratory Services: Improve the quality of laboratory services towards accreditation based on national, regional and international standards.
  • Regulatory Systems: Promote and support harmonised national and regional regulatory systems for diagnostic products, technologies and services.
  • Communication & Knowledge Management: Strengthen data collection, analysis and sharing capacity, communication platforms and advocacy to promote the laboratory profession and contribute to evidence-based laboratory medicine in Africa.

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2. African Medicine Quality Forum (AMQF)

The African Medicines Quality Forum (AMQF) is the quality control (QC) voice of African Medicines Regulatory Harmonization (AMRH) and plays a key role in all medicine’s QC related issues in Africa. It is a platform for a holistic continental quality control agenda that:

  1. Facilitates sharing of best practices;
  2. Promotes cooperation among National Quality Control Laboratories (NQCLs);
  3. Sets conformity assessment standards;
  4. Provides technical leadership in quality control; and
  5. Serves as an advocacy platform to raise the national and international visibility of NQCLs.

AMQF is open to participation by the heads of NQCLs from all African countries and formally reports to the African Medicines Regulatory Harmonization (AMRH) Steering Committee.

Membership

All NQCLs from 40 AU member states.

Vision

Africa free from Substandard and Falsified Medicines.

Mission

To protect the African People`s health by ensuring quality of health commodities through harmonized quality control systems, strengthened national, interregional and continent collective responsibilities and mutual accountability.

Goal


To build and strengthen the capacity of African National QC labs which, in turn, will contribute significantly to reducing sub-standard and falsified medical products in circulation on the African markets. AMQF’s scope of work includes capacity building, bioanalytical testing, communications, advocacy, information sharing, regional post-marketing surveillance (PMS), Proficiency testing and Quality Management Systems.

AMQF - Technical Working Group (AMQF – TWG)

AMQF – TWG is a core 13-member group, headed by a chair and vice-chair, representing all 8 Regional Economic Communities (RECs) in Africa that:

  • Provides technical leadership for AMQF
  • Develops annual workplans - aligned with its statement of work (SOW) for validation at annual meetings
  • Tracks workplan progress and disseminates AMQF documents

AMQF-TWG Members are from:

  • Cameroun, LANACOME
  • Cote d’Ivoire, LNSP
  • Ethiopia, FMHACA
  • Ghana, FDA Ghana
  • Mali, LNS
  • Morocco, LNCM
  • Nigeria, NAFDAC (Yaba Central NDQCL)
  • South Africa, CENQAM
  • Tanzania, TMDA
  • Tunisia
  • Uganda, NDQCL
  • Zambia, NDQCL
  • Zimbabwe, MCAZ