Essential medicines and health products

Regulatory system strengthening

National regulatory authorities (NRA) play a vital role in the health care system by providing regulatory oversight of all medical products such as medicines, vaccines, blood products, traditional or herbal medicines and medical devices.

WHO

Helping NRAs fulfil their mandate in an effective, efficient, predictable and transparent manner is therefore of critical importance in ensuring the quality, safety and efficacy of health products in an increasingly complex global environment. This also embodies the mission of the Regulatory System Strengthening (RSS) team.

NRAs perform their mandate based on a legal framework and a set of recommended regulatory functions that span the medical product lifecycle including clinical trial oversight, marketing authorisation and registration, licensing and inspection of premises, market surveillance and enforcement activities when required.

The RSS team helps Member States strengthen regulatory systems through a variety of approaches including:

  • The assessment of regulatory functions using a standardized tool and the creation of an institutional development plan (IDP) designed to bring each NRA up to benchmarked international standards.
  • Direct technical assistance based on country IDPs.
  • Support for information and work-sharing arrangements made possible through the implementation of harmonized standards and best practices and the creation of regional and global regulatory networks.

The WHO Global Benchmarking Tool (GBT) helps measure national regulatory systems against defined indicators in order to identify areas for improvement in the form of IDPs. Supported by WHA Resolution 67.20 on Regulatory System Strengthening and counterpart WHO Regional Committee resolutions, a key objective of the benchmarking process is to help regulatory authorities, particularly those in low- and middle-income countries, reach a level of maturity commensurate with a stable well-functioning and integrated system of oversight for medical products (Maturity Level 3).

Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization, and Global Learning Opportunities (GLO) efforts dedicated to enhancing the professional knowledge and skills of NRA staff and other professionals through a series of innovative learning opportunities.