Blog 2

Name of Guidance
· ICH Guidance E2C Clinical Safety Data Management Periodic Safety Update Report for Marketed Drugs

Status of Guidance: Draft/Final Guidance
· This guidance the final addendum to E2C Clinical Safety Data Management Periodic Safety Update Report for Marketed Drugs

When was the Guidance released?
· This E2C ICH guidance was released in February 2004. Endorsed by the ICH, November 1996, published by the FDA 1997. It is implemented in some but not all ICH countries

Link to the Guidance
· http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129455.pdf

Target audience
· Pharmaceutical Industry, Regulatory Authorities in the European Union, Japan and US, Marketing Authorization Holders, Medical Writers, Ethics Committee

Laws and Regulations Referenced (and what each law states in relevant part}
· U.S. Department of Health and Human Services
· Food and Drug Administration (FDA)
· Division of Drug Information, HFD-240
· Center for Drug Evaluation and Research (CDER)
· Center for Biologics Evaluation and Research (CBER)

Summary
· The periodic safety update report (PSUR) is a practical tool for summarizing interval safety data particularly covering short periods i.e., six months to one year, for conducting an overall safety evaluation.

Rationale
· The ICH E2C guidance was developed to harmonize PSURs submitted to regulatory authorities in terms of content and format as well as to introduce the concept of international birth date (IBD).

Resulting Recommendations
· Information on all indications, dosage forms, and regimens for the active substance should be included in a single PSUR, with a single data lock point common for all aspects of product use.
· Consistent, examination of the safety information for the active substance(s) in a single document. Relevant data relating to a particular indication, dosage form, or dosing regimen, and safety issues should be presented in a separate section within the body of the PSUR.
· Regulatory authorities should be notified and their agreement at time of authorization, for instances where a separate PSURs may be considered appropriate. For example:
Fixed combinations: Options include either a separate PSUR for the combination with cross-reference to the single agent(s) PSUR(s) or inclusion of the fixed combination data within one of the single agent PSURs.

When an active substance is used in two or more different formulations (e.g., systemic preparations versus topical administration), two or more PSURs, with the same or different IBDs, can be useful.

Impact
· The PSUR is a tool for marketing authorization holders (MAH) to conduct systematic analyses of safety data on a regular basis.
· The PSUR covers ongoing safety issues, and should include updates on emerging and/or urgent safety issues, and major safety signal detection and evaluations addressed in other documents.
· PSURs are of value and importance to all parties in protecting the public health.