WHO published the Good Regulatory practice (GRP) for medical products guidance (1). However, no legally binding GRP standard has been established. The purpose of this document is to provide guidance to national authorities responsible for regulatory oversight of medical products regarding common gaps in regulatory practices identified during benchmarking exercises.
The GRP can be defined as a set of principles and practices that guide the development, implementation, and review of regulatory instruments – laws, regulations, and guidelines – to achieve public health policy objectives as effectively as possible (2). The GRP objectives are:
- Ensure sound and effective regulation of medical products
- Higher-quality regulation, better regulatory decision-making, and compliance
- More efficient regulatory systems and better public health outcomes
- Up-to-date regulatory systems
- Promote trust among regulatory authorities and other stakeholders
- Facilitate international cooperation.
The GRP guidance identifies nine principles of good regulatory practices:
- Legality
- Consistency
- Independence
- Impartiality
- Proportionality
- Flexibility
- Clarity
- Efficiency and transparency
The Expert Committee adopted the GRP in the regulation of medical products. WHO Member States are encouraged to implement GRP in their regulatory systems with due consideration of the realities of their legal and regulatory systems. Even in the midst of a crisis, well-designed regulatory systems are capable of adhering to tried and tested recommendations on regulatory policy and governance.
1 WHO Good regulatory practice for regulatory oversight of medical products, 2020
2 WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fifty-fifth report