Post-marketing surveillance study [PMS]

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A post-marketing surveillance study (PMS study), also known as a Phase IV study, may be voluntary or imposed by the regulatory authorities. They are conducted after marketing authorisation is granted and the medicine is in general use. Post-marketing surveillance studies collect additional information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when it is used widely.

Phase IV Trial
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