Инструмент ВОЗ для оценки регуляторной системы в сфере обращения лекарств. Из серии по Регуляторной поддержке, No.11 (прилагается к Практическому руководству по проведению исследования). (English translation: WHO Data Collection Tool for the Review of Drug Regulatory Systems. Regulatory Support Series, No.11. (To Be Used Jointly with the Practical Guidance for Conducting a Review)
(2007; 72 pages) [English]


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.
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