LabTrain 2.0

Strengthening Sustainable Drug Quality Control and Laboratory Standard Compliance to Ensure Access to Safe Medicines in Western and South-Eastern Africa

Projektlogo des GHPP-Projekts LabTrain 2.0 )

Context

In many countries in Western and South-Eastern Africa, access to safe and effective medicines remains a challenge. A key factor is the limited capacity of national drug quality control laboratories. Insufficient structures, resources or standardised procedures hinder reliable quality testing. As a result, substandard or falsified medicines may reach patients, undermining treatment outcomes and contributing to antimicrobial resistance. Building on the successes of the predecessor project LabTrain, LabTrain 2.0 expands and deepens its approach both regionally and technically. The project aims to sustainably strengthen the capacities of eight selected national medicines quality control laboratories in West and South-Eastern Africa and to further improve their alignment with international laboratory standards. At the core of the project is a structured assessment of the partner laboratories as well as the development of tailored implementation plans. Building on this, LabTrain 2.0 supports the establishment and enhancement of quality management systems. It provides practice-oriented training and workshops for laboratory staff and managers. Furthermore, the project promotes regional networking and professional exchange. In cooperation with the World Health Organization, standardised testing methods for anti-infective medicines, as well as innovative and sustainable quality control strategies, are developed. In this way, market surveillance in project countries is strengthened, making an essential contribution to the protection of public health.

 

Objective

Improved drug surveillance in Africa by establishing international laboratory standards at selected African drug quality control laboratories (NDQCLs)

 

In Cooperation with

  • African Medicines Quality Forum (AMQF), Midrand, South Africa
  • Botswana Medicines Regulatory Authority (BoMRA), Gaborone, Botswana
  • Food And Drugs Authority (FDA) Ghana, Accra, Ghana
  • Institut National de Santé Publique (INSP) du Burundi, Bujumbura, Burundi
  • Liberia Medicines & Health Products Regulatory Authority (LMHRA), Monrovia, Liberia
  • Medicines Control Agency (MCA) The Gambia, Banjul, The Gambia
  • Medicines Control Authority of Zimbabwe (MCAZ), Harare, Zimbabwe
  • Namibia Medicines Regulatory Council (NMRC), Windhoek, Namibia
  • Pharmacy Board of Sierra Leone (PBSL), Freetown, Sierra Leone
  • World Health Organization (WHO), Geneva, Switzerland
  • InphA (Institute for Pharmaceutical and Applied Analytics), Bremen, Germany

Thematic priorities

  • Infection prevention and control
  • Marketing authorisation and safety of medicinal products
  • One Health - Antimicrobial Resistance

Facts

Duration

01.01.2026 - 31.12.2028

Budget

ca. 1,600,000 EUR

Project Countries

  • Botswana
  • Burundi
  • Gambia
  • Ghana
  • Liberia
  • Namibia
  • Sierra Leone
  • Zimbabwe

Contact

Dr Yvonne Urbach
Prof Dr Britta Hänisch
Federal Institute for Drugs and Medical Devices (BfArM)
Kurt-Georg-Kiesinger Allee 3
53175 Bonn, Germany
Yvonne.Urbach@bfarm.de
Britta.Haenisch@bfarm.de

Activities

  • Research and provision of evidence

    The project supports applied research activities, particularly in developing and validating new analytical methods and quality control procedures through collaboration with the World Health Organization (WHO). These efforts contribute to global knowledge sharing and the establishment of standardised approaches for medicine quality control.

  • Networking and cooperation

    The project strengthens structured cooperation between national drug quality control laboratories. Through regional laboratory networks, joint activities, and close collaboration with the World Health Organization, it expands professional exchange and reinforces sustainable partnerships.

  • Capacity building

    The project strengthens the organisational and technical capacities of national drug quality control laboratories. It supports the implementation and further development of quality management systems, structured improvement planning, and alignment with international laboratory standards.

  • Training and competence development

    LabTrain 2.0 systematically strengthens the skills of laboratory staff and managers. Through hands-on training, workshops, mentoring, and train-the-trainer formats, technical, methodological, and organisational competencies are sustainably enhanced.