How to Develop and Implement a National Drug Policy (Second Edition)
(2001; 96 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentContributors
View the documentAbbreviations and acronyms
View the documentPreface
Open this folder and view contentsPart I: How to develop and implement a national drug policy
Close this folderPart II: Key components of a national drug policy
Open this folder and view contents4. Selection of essential drugs
Open this folder and view contents5. Affordability
Open this folder and view contents6. Drug financing
Open this folder and view contents7. Supply systems
Close this folder8. Drug regulation
View the document8.1 Need for drug regulation and quality assurance
View the document8.2 Basic requirements for drug regulation
View the document8.3 Core elements of drug regulation
View the document8.4 Stepwise approach to drug registration
View the document8.5 Quality
View the document8.6 Safety
View the document8.7 Efficacy
View the document8.8 Information and drug promotion
View the document8.9 Information exchange with WHO and with other agencies
Open this folder and view contents9. Rational use of drugs
Open this folder and view contents10. Research
Open this folder and view contents11. Human resources development
Open this folder and view contents12. Monitoring and evaluation
View the documentReferences
View the documentSelected WHO publications and documents of related interest
View the documentBack cover

8.3 Core elements of drug regulation

The main tasks of a DRA are to ensure the quality, safety and efficacy of drugs (including traditional and herbal medicines), and the appropriateness of product information. These four aspects can be translated into a set of core elements of drug regulation (see Box 7).

Box 7

Core elements of drug regulation


Review of quality as part of product registration
Formulation of norms and standards
Licensing of facilities and personnel
Inspection of facilities and products
Drug quality control


Review of safety as part of product registration
Adverse drug reaction monitoring
Issue of warnings, recall of products


Review of efficacy as part of product registration
Authorization of clinical trials


Review and approval of product data sheets and labels
Regulation of advertising and drug promotion

The various core elements are discussed in sections 8.5-8.9, with reference to relevant WHO publications and other materials that provide the necessary technical details.

Building an effective and efficient drug regulatory authority is a long and arduous task that may take years to accomplish, with considerable personnel and financial investment. A stepwise approach is usually recommended. In this respect, WHO’s National drug regulatory legislation: guiding principles for small drug regulatory authorities is relevant for countries with limited resources.45 This document and most other relevant materials have been brought together in a compendium of WHO guidelines and related materials, published in two volumes.46

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