Resolution WHA67.20 on Regulatory System Strengthening for medical products, which was approved by the Sixty-seventh World Health Assembly in May 2014, recognizes that effective regulatory systems are an essential component of health system strengthening, contribute to better public health outcomes, and are necessary to the implementation of universal health coverage. The Resolution also recognizes that inefficient regulatory systems can be a barrier to access to safe, effective and quality medical products.
WHO’s objectives in the area of regulatory system strengthening are to:
- Promote cooperation on regulatory matters, convergence and transparency through networking, work-sharing and reliance; and
- Build capacity in Member States consistent with good regulatory practices.
These objectives are intended to facilitate the availability of safe, effective and quality medical products by assisting countries reach and sustain a level of regulatory oversight that is effective, efficient and transparent.
WHO understands that an increasing number of entities are involved in efforts to strengthen regulatory systems at country, regional and/or global level. WHO also recognizes the value of networks, collaboration and coordination (particularly given limitations in resources) in achieving the aforementioned objectives, in enhancing the effectiveness of regulatory support outcomes and, conversely, in avoiding fragmented or uncoordinated support to Member States.