(2001; 96 pages) [French] [Spanish]
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.
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.