International Guidelines

Many perspectives, many points of agreement

When looking from a global perspective at the myriad national systems for regulating medical products, it becomes clear there is no single correct approach. Nations differ widely in terms of specific health priorities, socioeconomic development, infrastructure and resource availability, disease burden and legal system.

Despite all these areas of variance, however, it has also become progressively clearer that certain practices lend themselves better than others to application on a global scale.

Recognizing the opportunity for better standardization of regulatory practices across international borders, the World Health Organization (WHO) established in 2016 a set of guidelines for achieving it. These “good regulatory practices” (GRP) have been informed by a number of less comprehensive international guideline sets issued over the past few decades, and are based on promoting transparency and sound government policy-making.

Principles of good regulatory practices

According to WHO’s international guidelines, member-state regulatory systems for medical products should abide by nine principles:

  1. Regulations should have a sound legal basis and should be consistent with existing legislation, including international norms or agreements.
  2. Regulatory decisions should be fair and impartial to avoid conflicts of interest, unfounded biases or improper influence from stakeholders.
  3. Regulations should be applied with consistency; the regulated party should understand clearly communicated expectations and the consequences of noncompliance.
  4. Regulations and regulatory decisions should be proportional to the risk (i.e., only what is necessary to achieve objectives).
  5. Regulations should not be prescriptive; they should allow flexibility in responding to a changing regulated environment and unanticipated circumstances.
  6. Regulations should be effective in producing the intended result.
  7. Regulations should be efficient in achieving their goals (i.e., within the allotted time and budget).
  8. Regulations should be communicated with clarity (i.e., accessible to, and understood by, the users).
  9. Regulatory systems should be transparent; requirements and decisions should be made known to affected parties and, where appropriate, to the general public.

As international guidelines, GRP principles are an important part of WHO’s assessment of national regulatory authorities. Member states wishing to qualify for the trusted WHO-Listed Authorities (WLA) designation must demonstrate a commitment to following and achieving them.