Blog 3

Blog 3

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

Status
This final guidance addendum is intended for preparation of the periodic safety update report recommended in the ICH guidance E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs. The guidance was published by the FDA in May 1977 and updated February 2004.

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

Target Audience
This guidance is targeted for regulatory authorities, marketing authorization holders, and all parties protecting public health. This guidance is implemented in some but not all ICH countries.

Laws & Regulations
This guidance represents the Food and Drug Administration current thinking on safety update reporting. It is also the ICH safety update reporting Guidance for the industry.

Summary
The PSUR is a practical and achievable way for summarizing interval safety data for periods of 6 months and/or 1 year and the overall safety evaluation of the compound. Marketing authorization holders use the PSUR to conduct analyses of safety data on an ongoing basis. The PSUR should include updates on major signal detection and evaluation addressed in other documents and emerging or urgent safety issues.

The PSURs are valuable to all parties protecting public health. The guidance was developed to harmonize PSUR submission to regulatory authorities for content and format and to introduce the concept of international birth date.

The original guidance was misinterpreted by marketing authorization holders and regulatory authorities. Therefore, the Counsel for International Organizations of Medical Science (CIOMS) Working Group V made recommendations and developed concepts to harmonize the practice for PSUR preparation. This addendum should always be used in conjunction with the E2C guidance.

Rationale
This is an ICH requirement for a practical achievable method for summarizing interval safety data on marketed drugs.

Resulting Recommendations
The recommendation is for a single PSUR, information on indication, dosage forms, and regimens for active substance should be included, with a single data lock point for all aspects of product use. Having consistent broad-based examination of safety information for active substance(s) in a single document is recommended. Data relevant to a particular indication, dosage form, or dosing regimen should be presented separately within the body of the PSUR with safety issues addressed accordingly.

Impact
This guidance harmonizes safety reporting in most countries. Periodic Safety Update Reports have a great impact on the timely safety reporting of marketed drugs and the protection of public health.