Medicines

Assessing national medicines regulatory systems

Assessing national medicines regulatory systems National Medicines Regulatory Authorities (MRAs) are responsible for the regulation and control of medical products such as medicines, vaccines, blood products and medical devices. They contribute to promoting and protecting public health by ensuring that:

  • medicines are of the required quality, safety and efficacy,
  • health professionals and patients have the necessary information to enable them to use medicines rationally,
  • medicines are appropriately manufactured, stored, distributed and dispensed,
  • illegal manufacturing and trade are detected and adequately sanctioned,
  • promotion and adverting is fair, balanced and aimed at rational drug use,
  • access to medicines is not hindered by unjustified regulatory work.

Intensification of international commerce and increasing technological complexity of manufacturing and product specifications have created additional challenges for national regulatory authorities and manufacturers, particularly to those of developing countries. This requires that national regulatory capacity is regularly assessed, areas of weakness are identified and appropriate, necessary measures are taken. Assessments are conducted using a standardized WHO Data Collection Tool for the review of Drug regulatory Systems.

Objective of assessments of national regulatory systems

Reviews aim at strengthening national regulatory and control capacity through an assessment of the situation, the identification of specific needs, and the provision of appropriate technical support and training.

  • review the existing legal framework, regulations and control activities with regard to medicinal products and medical devices in order to assess the national regulatory capacity against a set of predefined parameters;
  • in collaboration with national officials, identify gaps and develop strategies to address these gaps;
  • identify specific areas and activities for WHO’s technical input.

Practical Guidance for Conducting a Review has been developed to help regulatory authorities to perform assessments using the WHO Data Collection Tool. This guidance provides technical advise on how to conduct the review and contains practical information and advice on the duration and tentative programme of the assessment mission, proposed composition of the assessment team, institutions and persons to be met, etc. The Guidance is annexed with the examples of the forms and templates needed during the assessment, as well as the model template of the assessment report and the format of the plan of corrective measures.

WHO data collection tool for the review of drug regulatory systems
Practical Guidance for Conducting a Review
Assessment of medicines regulatory systems in sub-Saharan African countries. An overview of findings from 26 assessment reports
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