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

8.6 Safety

The safety of a drug or medical device is one of the criteria for market approval, and is reviewed as part of the registration process. Adverse drug reaction monitoring, and systems for early warnings and recalls are additional ways of ensuring safety after market approval.

Monitoring of adverse drug reactions

National and international pharmacovigilance systems are needed to collect and evaluate information on adverse drug reactions. However, in countries with limited regulatory capacity, establishing a national pharmacovigilance system may not be a priority. If serious adverse reactions lead to the withdrawal of, or severe restrictions on, a drug in one country, this information is made available through various channels. These include WHO’s Drug Alert messages, which are sent to all DRAs, and publications from the WHO Collaborating Centre for International Drug Monitoring in Uppsala, Sweden.

Countries should consider whether they have the capacity and resources to establish their own adverse reaction reporting mechanism, and the regulatory capacity to use the information gathered. If they do not, they should consider how they can best use the information that is available internationally.

Warning/recall systems

Whether information is based on data from a national system of adverse drug reaction monitoring or available from international adverse drug reaction reporting systems, national DRAs must consider how they can best use the information. Examples of possible actions include suspension of a drug’s market approval, the recall of certain batches, a warning in a national drug bulletin, or a separate warning sent out to a list of institutions and key prescribers.

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