Good regulatory practices in the regulation of medical products
Background:
A fundamental role of government is to protect and promote the health and safety of the public, including by delivering health care. A well-functioning health care system requires available, affordable medical products that are safe, effective and of assured quality. As medical products are essential in the prevention, diagnosis and treatment of disease, the consequences of substandard and falsified medical products can be life threatening. This is a concern, as users of medical products are not usually in a position to judge their quality. The interests and safety of the public must therefore be entrusted to a regulatory body or bodies that ensure that only products in legal trade are available and that marketed products are safe, perform as claimed and are of assured quality.
The regulation of medical products has become increasingly complex with the globalization of product development, production and supply and the rapid pace of technological and social change in the context of limited financial and human resources. The importance of robust regulatory systems was recognized by the Sixty-Seventh World Health Assembly when it endorsed resolution WHA 67.20, Regulatory system strengthening for medical products. The resolution notes that “effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes”, that “regulators are an essential part of the health workforce” and that “inefficient regulatory systems themselves can be a barrier to access to safe, effective and quality medical products” (23).
A sound system of oversight requires that regulatory authorities be supported by an effective framework of laws, regulations and guidelines and that they have the competence, capacity, resources and scientific knowledge to deliver their mandate in an efficient and transparent manner. The extent to which a regulatory framework fulfils its policy objectives depends on the quality of its development and implementation. GRP are critical to efficient performance of a regulatory system and, consequently, to the public’s confidence in the system, while also setting clear requirements for regulated entities. A sound regulatory framework, including international norms and standards, and the recruitment and development of competent staff are necessary but not sufficient conditions to ensure “good oversight”. All individuals in regulatory authorities should be guided by GRP in setting appropriate requirements and formulating decisions that are clear, transparent, consistent, impartial, proportionate, timely and based on sound science. Regulated parties and other stakeholders also play important roles in ensuring a clear, efficient regulatory environment so that quality-assured medical products are available to patients.
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Table of Contents
7. Overview of a regulatory system
for medical products
8. Principles of good regulatory
practices
9. Enablers of good regulatory
practices
WHO TRS (Technical Report Series) 1033, 2021 Annex 11:
