Safety - Pharmacovigilance  FDA / EMA Regulations

Clinical safety management: definitions and standards for expedited reporting: ICH Topic E2A, 27 October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

Detailed guidance on the collection, verification, and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use: CT-3, June 2011. This detailed guidance addresses the collection, verification and reporting of adverse events and adverse reactions which occur in a clinical trial falling within the scope of Directive 2001/20/EC, i.e. a clinical trial as defined therein and performed in at least one EU Member State.

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, 21 CFR Parts 312 (IND studies) and 320 (BA-BE studies). September 2010, effective 28 March 2011. The final rule codifies the agency’s expectations for timely review, evaluation, and submission of relevant and useful safety information...

FDA - Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies. Guidance for Industry and Investigators. December 2012.
This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides advice on other safety reporting issues that have arisen from sponsors and investigators.