Periodic Reporting (DSUR/PSUR) to Regulatory Authorities and Investigational Sites
During the drug development and after the drug is on the market, the sponsor or market authorization holder has obligations to submit the safety information to regulatory agencies periodically.
Drug Safety Update Reports (DSURs) cover drugs, biological, vaccines, and combo products. They are submitted to regulatory agencies and sometimes also to Ethics Committees/IRBs. There should be only one DSUR for one investigational drug and in most countries it is submitted annually.
Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization.
PSUR submissions are not required for all medicinal products, but the need for PSURs is determined using a risk-based approach. Certain products authorized under certain legal basis are exempted to submit PSURs routinely. For such products, PSURs shall be submitted only where there is a condition in the marketing authorization or when requested by a competent authority. The PSUR submission frequency is variable. Marketing Authorization Holders (MAHs) are required to submit PSURs according to the data lock points published in the EURD list.
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