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. Drug regulation

Key policy issues

The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. Key policy issues are:

• government commitment to drug regulation, including the need to ensure a sound legal basis and adequate human and financial resources;

• independence and transparency of the drug regulatory authority; relations between the drug regulatory authority and the ministry of health;

• stepwise approach to drug evaluation and registration; definition of current and medium-term registration procedures;

• commitment to good manufacturing practices, inspection and law enforcement;

• access to drug control facilities;

• commitment to regulation of drug promotion;

• regulation of traditional and herbal medicines;

• need and potential for systems of adverse drug reaction monitoring;

• international exchange of information.

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