Developed by: World Health Organization (WHO)

Objective: To strengthen the national medicines regulatory and control capacity through an assessment of the drug regulatory system.

Output: The tool output enables the following: (1) a review of the existing legal framework, regulations and control activities with regard to medicinal products, in order to assess the national regulatory capacity, (2) identification of gaps and the development of strategies to address these gaps, (3) identification of specific areas and activities for WHO’s technical input.

Additional information: The growth of international commerce and increasing technological complexity of manufacturing and product specifications have created additional challenges for national regulatory authorities and manufacturers, particularly for developing countries. This requires that national regulatory capacity is regularly assessed, areas of weakness are identified and necessary measures are taken. This tool enables a standardised assessment to be conducted. If used from time to time on the same national medicines regulatory authorities, it can monitor the results brought by a project. The methodology enables the assessor to apply this tool not only for pharmaceutical products but also for other health care products such as medical devices, cosmetics, etc. Assessment reports are confidential and only sent back to the NMRA who has undergone the assessment.

Process and resources:

• The tool is used mainly for an external assessment but can also be used for self-assessment and monitoring. 
• It should be used jointly with the Practical Guidance for Conducting a Review at:
  www.who.int/medicines/areas/quality_safety/regulation_legislation/GuideAssessRegSys.pdf , which has been developed to help regulatory authorities to perform assessments using the WHO Data Collection Tool.
• The tool requires technical support from WHO and WHO-contracted independent inspectors.
• External assessors should be independent, and have experience of conducting an assessment and extensive knowledge of regulatory functions (required skills are detailed in Annex 2 of the Practical Guidance for Conducting a Review).
• A full self-assessment will take approximately two weeks.
• An external assessment involving WHO/HQ will require preparation time of on average two-three months.
• The cost of an external assessment by a WHO expert and an external assessor ranges from US$10,000- $15,000.

Link to the tool: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/ENdatacollectiontool.pdf