TableĀ 2

Factors hindering versus helping the implementation of MQAS standards

Hindering factorsRegionHelping factors
  • Poor knowledge of the MQAS

  • Limited dissemination of the MQAS

Both regions
  • Perception of the MQAS as a regulatory standard

  • Stringent regulatory system at national level

  • International regulatory harmonisation

  • Financial and judicial autonomy of the procurement agency

  • Lack of organisational commitment to quality

  • Weak European Union regulatory oversight on quality of export-only products

  • Commercial incentives for quality (ie, the purchasers require quality assurance)

  • Lack of human resources

  • Lack of resources of regulatory authorities (NMRAs)

  • Weakness of national QC laboratories

  • Poor transparency of the information provided by suppliers

Sub-Saharan Africa
  • Capacity building, for example, by international aid agencies

  • MQAS audits by international agencies

  • Promotion of the MQAS

  • Awareness of the MQAS

  • MQAS, Model Quality Assurance System; NMRAs, National Medicines Regulatory Authorities; QC, quality control.