Practical Guidance for Conducting a Review. Regulatory Support Series, No.12 (Based on the WHO Data Collection Tool for the Review of Drug Regulatory Systems)
(2007; 94 pages)


WHO's role in medicines regulation is based on its constitutional mandate and various World Health Assembly resolutions. These require WHO to support member states in their efforts to implement national medicines policies and programs, to ensure equity of access to essential medicines, medicines safety and quality, and the appropriate use of medicines. More specifically, WHO is requested to provide guidance and support on the setting up of efficient national medicines regulatory mechanisms, to ensure that available medicines are of good quality and to fight against counterfeited medicines.

TCM continues to assist countries on regulatory issues such as assessment of regulatory capacities and skills building. Greater focus is however being given to stimulating the country's commitment to effective regulation and to enable countries to determine themselves how their resources can be developed and applied most effectively...

Poor or inadequate regulation can lead to the prevalence of poor standard, counterfeit, harmful and ineffective drugs on national markets and in the international commerce. This can result in serious harm to the health of individual consumers and even to the health of a wider population. Therefore, countries must continuously strengthen key drug regulatory responsibilities so as to ensure the safety, quality and efficacy of drugs and the accuracy of product information.

Countries should assess their drug regulatory performance using indicators that focus on structures and inputs, processes and outcomes. They should identify any strengths and weaknesses, the reasons for them and consider alternative regulatory options, using the most appropriate and practical choices.

The WHO Data Collection Tool for the review of Drug regulatory Systems has been designed1 to help regulatory authorities perform such an assessment. More information on the design and development of this tool is provided in annex 12. This guidance provides technical advise on how to conduct this review.

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