Pharmaceutical Legislation and Regulation. (MDS-3: Managing Access to Medicines and Health Technologies, Chapter 6)
(2012; 21 pages)


Realistic and effective laws and regulations are needed for the pharmaceutical sector because -

  • Pharmaceuticals concern the whole population
  • Many parties are involved: patients, health providers, manufacturers, and salespeople
  • Serious consequences, including injury and death, can result from the lack or misuse of medications
  • The consumer has no way to determine product quality
  • Informal controls are insufficient

Countries may choose to develop new legislation or to revise existing laws. When starting afresh, it is useful to prepare a general law. Models exist, and expert assistance is readily available. After the law is passed, regulations made under it can bring its various provisions into operation, one by one, as the necessary resources and experience are acquired.

In drafting or revising legislation, a country should -

  • Inventory the laws and regulations already in force
  • Determine what type of legislative instrument is required
  • Involve both legal and health experts
  • Keep all interested parties informed

National drug legislation generally includes provisions relating to the manufacturing, importing, distribution, marketing, prescribing, labeling (including language), dispensing, and sometimes pricing of pharmaceutical products, as well as the licensing, inspection, and control of personnel and facilities. A regulatory authority is usually established for administrative control. Medicine registration is often a major element in legislation, to ensure that individual products meet the criteria of efficacy, safety, and quality.

Countries that need to introduce comprehensive legislation can seek guidance from the experiences of others and from WHO (2001a) guidelines.

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