Regulatory Systems

Strong pharmaceutical regulatory systems are essential to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services that contribute to better health care delivery systems.

National medicines regulatory authorities (NMRAs) in low- and middle-income countries (LMICs) face significant challenges in controlling the quality, safety, and efficacy of medical products circulating on their markets or passing through their territories. In sub-Saharan African countries, for example, an assessment of 26 NMRAs published by the World Health Organization (WHO) in 2010 found that although countries had legal provisions for most essential aspects of medicines control, capacity was inadequate and regulatory measures did not form a coherent control system.

Weaknesses in pharmaceutical regulatory systems contribute to limited access to quality-assured, safe, and efficacious life-saving essential medicines, including those for malaria; HIV/AIDS; and reproductive, maternal, and childhood diseases, and to the disruption of health service delivery, thereby preventing achievement of better health outcomes.

MTaPS program supports LMICs to improve their pharmaceutical regulatory systems, including pharmacovigilance (PV) systems, to deliver safe, effective, and quality-assured medicines by:

  • Strengthening regulatory capacity and pharmaceutical-sector governance to protect the public from substandard and falsified products
  • Promoting transparency and accountability through appropriate laws, regulations, policies, and standard operating procedures
  • Improving human and institutional capacity to manage pharmaceutical regulatory systems and services, including protecting patient safety and slowing the emergence and spread of antimicrobial resistance

MTaPS helps countries:

  • Adopt model pharmaceutical legislation, policies, guidelines, and norms or update existing tools that promote equitable and sustainable access to safe, efficacious, and quality-assured medical products ( i.e., medicines, medical devices, and other health products)
  • Establish mechanisms to ensure oversight and enforcement of policies, laws, and regulations, including the development of country-specific strategies for enforcement and compliance and collaboration with national, regional, and international authorities
  • As an entry point, support NMRAs’ strategic planning for regulatory system strengthening with a focus on product registration
  • Develop NMRAs’ institutional capacity for on-the-job training, knowledge sharing, and adaptation of model tools (SOPs and guidelines) and help establish certification programs to encourage continued capacity development and resource optimization
  • Support strengthening/developing pharmaceutical regulatory professionals and preservice programs in collaboration with MTaPS partners - Regional Centres of Regulatory Excellence in Africa and the Centre of Regulatory Excellence in Asia
  • Support coordination and advocacy efforts for regional harmonization through regional economic communities and platforms like the African Medicines Regulatory Harmonization initiative
  • Support regional coordination of assessment, technical assistance, and M&E for regulatory systems strengthening in collaboration with stakeholders and donors (e.g., WHO, World Bank, Bill & Melinda Gates Foundation)
  • Support interoperability of regulatory data among countries through data requirement analysis, creation of data exchange systems, and use of information solutions such as Pharmadex for medicines registration; PViMS for active surveillance of and spontaneous reporting on medicine safety; and WHO GBT for assessment of regulatory systems
  • Validate the effectiveness of innovative community point-of-sale screening of substandard and falsified medicines to improve patient safety
  • Improve PV systems and design active surveillance systems for new medicines to support the use of high-risk and novel technologies
  • Support behavior change interventions for providers and patients to increase voluntary reporting of adverse drug events

Download MTaPS Regulatory Systems factsheet

For more information, contact:

Principal Technical Advisor, Regulatory Systems

Kate Kikule
[email protected]