postauthorization

Postauthorization refers to the set of activities and obligations that occur after a medicinal product has received regulatory approval for marketing. It encompasses ongoing safety, efficacy, and quality monitoring to ensure that the product continues to meet approved conditions of use and maintains an acceptable benefit–risk balance.

Key components of postauthorization include pharmacovigilance and safety monitoring, postauthorization studies, and regulatory reporting. Pharmacovigilance involves collecting, assessing, and responding to new information about adverse events and product risks. Postauthorization studies, such as postauthorization safety studies (PASS) and postauthorization efficacy studies (PAES), are conducted to gather additional data on safety or effectiveness in real-world settings. Periodic reporting requirements, such as periodic safety update reports (PSUR) or periodic benefit–risk reevaluations, provide ongoing evaluation of a product’s risk-benefit profile.

Risk management is another core element, often formalized in a pharmacovigilance system and risk management plan (RMP). The RMP outlines identified risks, proposed risk minimization measures (RMMs), and strategies for communication to healthcare professionals and patients. Throughout the postauthorization phase, labeling, dosing recommendations, and safety communications may be updated in response to new evidence. Manufacturing and quality aspects remain subject to regulatory oversight, with postapproval changes and inspections ensuring continued compliance.

Regulatory authorities in different jurisdictions oversee postauthorization activities. In the European Union, authorities emphasize PSURs, RMPs, and lifecycle management; in the United States, postmarket surveillance and safety communications play similar roles. Overall, postauthorization represents the ongoing lifecycle management of a product after initial approval to ensure continued patient safety and therapeutic value.