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.