Postmarketing surveillance

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Postmarketing surveillance is the practice of monitoring a pharmeceutical drug or device after it has been released on the market. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been "controlled" for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

In the United States, postmarketing surveillance is overseen by the FDA, which operates a system called Medwatch, to which doctors or the general public can voluntarily report adverse reactions to drugs. [1]

Health Canada is the regulatory body in Canada which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance. [2]

Pharmacovigilance is the name of postmarketing surveillance in Europe and New Zealand.


[edit] Footnotes

  1. ^ Post-marketing Surveillance. U.S. FDA/CDER (2004).
  2. ^ Post-marketing Pharmacosurveillance in Canada. Health Canada (2005). Retrieved on 2006-09-16.
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