Phase IV Trials« Back to Glossary Index
Phase IV trials are usually conducted after marketing authorisation is granted and the medicine is in general use.
Phase IV studies are also known as post-authorisation safety studies (PASS) and may be voluntary or imposed by the regulatory authorities. The possibility also exists of requesting the marketing authorisation holder to conduct post-authorisation efficacy studies (PAESs) in order to complement efficacy data that are available at the time of the initial authorisation. Phase IV studies collect additional information about side-effects and safety, long-term risks and benefits, and/or how well the medicine works when used widely.
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Phase IV Study, Phase IV Studies, Post-marketing surveillance study, post-marketing surveillance studies, Phase 4