Zdrowie i gospodarka · 11/04/2012

International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic Benefit-Risk Evaluation Report; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report." The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines two ICH guidances, "E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (E2C guidance) and "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" (addendum to the E2C guidance). The draft guidance describes the format, content, and timing of a periodic benefit-risk evaluation report (PBRER) for an approved drug or biologic. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.