This guide focuses on the management of clinical safety data, establishes standards and deadlines for the expedited reporting of adverse drug reactions, and includes definitions of concepts such as Adverse Event (AE), Adverse Drug Reaction (ADR or SAR), Suspected Unexpected Serious Adverse Reaction (SUSAR), and Adverse Event in Marketed Products.

This guide details the format and standards for the electronic transmission of the individual case safety report (ICSR) and the development of standards for the identification of medicinal products (MPID) (ICH M5), facilitating efficient communication among stakeholders. Its use is primarily focused on the pre-marketing and post-marketing of ICSRs, and its information centers on adverse events, patient reactions, and all important medical information.

Drug interactions occur when two or more drugs administered simultaneously or within a close timeframe act together, modifying or altering their original effect. These interactions can enhance, reduce, or even neutralize the effect of one or both drugs. It is crucial to consider this situation as they can lead to unwanted effects or decrease the effectiveness of the treatment. In some cases, interactions can be dangerous and compromise the patient's health. Therefore, it is essential that healthcare professionals are informed about all the medications and supplements a person is taking to prevent potential adverse events.

The E2C provides guidelines on the preparation and presentation of the PBRER, a report that periodically evaluates the benefit-risk ratio of a drug on the market, including approved products that are in the additional study phase. Its purpose is to assess the safety and efficacy of pharmaceutical products. These reports apply to different presentations such as: (i) active substances, (ii) combined products, and (iii) products manufactured and/or marketed by a company.

This guide focuses on the management of safety data after the approval of a drug, establishing standards for expedited reporting of adverse events and setting good practices for data management. This includes the evaluation of unsolicited sources, such as spontaneous reports and reviews of scientific literature.

This guide addresses the planning of pharmacovigilance activities after the commercialization of a drug, including risk assessment and information management through the summary of relevant information such as important risks, potential risks, and missing information of a drug, including at-risk populations and situations where drugs are used without prior study in a population. The application of this guide is useful for chemical entities, biotechnology-derived products, and vaccines, as well as significant product changes, new uses in populations, new indications, or the emergence of relevant safety concerns.