Post-Approval

A US supplement type allowing certain changes to be implemented upon FDA receipt (0 days), as permitted by regulations and guidance.

A US supplement type allowing certain changes to be implemented 30 days after FDA receipt, unless FDA informs otherwise.

A prospectively defined plan describing tests, acceptance criteria, and reporting for assessing a future manufacturing change, intended to facilitate predictable regulatory review.

Distribution restrictions used as a risk minimisation measure (e.g., certified prescribers/pharmacies, patient enrollment).

An official communication to healthcare professionals about important safety information and actions to minimize risk (EU term).

An annual report that provides a comprehensive, annual review of safety information for an investigational drug under development.

Risk minimisation materials for HCPs and/or patients that support safe use (e.g., checklists, guides, training).

A protocol submitted to define how certain future changes will be studied and implemented, supporting more predictable post-approval change management.

A US supplement for certain changes to an approved NDA/BLA that require FDA approval before implementation (e.g., some manufacturing or labeling changes).

A periodic report evaluating benefit–risk balance for a product, aligned with ICH E2C(R2) and used in many regions as an evolution of PSUR concepts.

Phase of the product lifecycle after approval. Includes post-marketing surveillance, PSURs, RMP updates, variations, and compliance with conditions of the marketing authorisation.

A study that a sponsor agrees to conduct after approval but is not legally required (distinct from PMRs).

A study or clinical trial that FDA requires after approval to assess known or potential serious risks or to confirm clinical benefit (e.g., under accelerated approval).

An EU document describing the MAH’s pharmacovigilance system, maintained for inspection and compliance evidence.

A report submitted at defined intervals that evaluates the benefit-risk balance of a medicinal product and summarizes new safety information. Required post-authorisation.

An EU process for a single assessment of PSURs for products containing the same active substance, supporting consistent safety conclusions across Member States.

The EU role responsible for oversight of the pharmacovigilance system and compliance with PV obligations.

A US risk management program required for certain drugs to ensure benefits outweigh risks, potentially including ETASU elements and communication plans.

A regulatory process to maintain a marketing authorisation beyond an initial validity period, where applicable, based on benefit–risk assessment and compliance.

Interventions designed to prevent or reduce the frequency or severity of adverse reactions and improve safe use (routine and additional measures).

A document describing the known and unknown safety profile of a medicine and the activities to characterise and minimise risks. Required in the EU and for many products in the US.

Activities to detect, validate, prioritize, assess, and recommend actions for new or changing safety information.

A US submission to an approved NDA to request a change such as a new indication, new dosage form, new manufacturing change, or labeling update.

An EU rule where a marketing authorisation may cease to be valid if the product is not placed on the market within a defined period or is absent from the market for a defined period, subject to exceptions.

A rapid, temporary change to product information or conditions of use to address an important safety concern while formal variation procedures proceed.