Promoting the Quality of Medicines Plus (PQM+)


ISO-17025 Waste Training in a regulatory Lab in Mozambique
     ISO-17025 waste training in a regulatory lab in Mozambique. Photo: PQM+ program

Mozambique established its National Pharmacy Directorate (Direcção Nacional de Farmácia, DNF) in 2017. PQM+ is working with DNF to build and strengthen its core regulatory functions, systems, and processes. This includes improving its regulatory and organizational capacity to comply with international standards for regulatory agencies overseeing pharmaceutical and other medical products.


To support the growth and oversight of the pharmaceutical sector in Mozambique, the country established an autonomous national medicines regulatory authority, the National Medicines Regulatory Authority, Public Institute (Autoridade Nacional Reguladora de Medicamentos, Instituto Publico, ANARME, IP) in 2019. As unified medicines regulatory body, ANARME, IP encompasses the national medicines quality control laboratory (Laboratório Nacional de Comprovação da Qualidade, LNCQ).


PQM+ assisted Mozambique’s national quality control laboratory (now the Department of Drug Quality Check, DCQ) in carrying out medicines quality testing to identify substandard and falsified medicines in the local market. Over the years, PQM+ has supported ANARME, IP in strengthening several key regulatory functions that include Risk-based Post-Marketing Surveillance (RB-PMS), Medical Product Evaluation and Market Authorization and Laboratory Testing based on established international standards and best-practices. PQM+ has been providing technical assistance to ANARME, IP on its journey towards attaining WHO GBT ML3 and achieving and maintaining ISO 9001:2015 certification. Additionally, PQM+ has been assisting LNCQ to identify and bridge gaps toward attaining ISO 17025:2017 accreditation. 

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