Risk Management

FDA programme to manage serious risks of a drug; may include ETASU (elements to assure safe use), communication plan, and implementation system.

Risk minimization measure beyond the SmPC/PL; e.g., educational materials, PPP, controlled access. GVP XVI requires effectiveness evaluation.

Evaluation of the positive therapeutic effects of a medicine versus its risks; must be favorable for approval and maintained post-approval.

Document describing known and unknown risks, pharmacovigilance activities, and risk minimization measures. Required in EU and updated through lifecycle.

Change to SmPC/PIL or local label following signal evaluation or regulatory request; must be implemented in all markets.

Communication to HCPs about an important safety issue (e.g., new contraindication, recall). Part of risk minimization.

Leaflet for patients supplied with the medicine; must be consistent with SmPC.

Symbol for intensive monitoring in EU; appears next to product name in PL. Encourages reporting.

EU mechanism for enhanced monitoring of certain products (e.g., new actives, biologics); black triangle and possibly PASS.

Situation in which the drug must not be used (e.g., hypersensitivity, pregnancy). Part of RSI and risk minimization.

Warnings and precautions in SmPC (section 4.4); important for safe use and risk minimization.

Safety monitoring and reporting specific to children; may have different labeling and RSI.

Patients typically ≥65 years; safety in elderly may be in SmPC and relevant for signal and RMP.

Use of drug during lactation; may be in SmPC and relevant for case assessment and RMP.

Part of RMP describing known and unknown safety profile, populations at risk, and missing information.

Part of RMP describing activities to address safety (e.g., studies, enhanced reporting).

Part of RMP describing aRMMs and how effectiveness will be measured.

Identified risk or potential risk that drives PV and risk minimization activities.

Gap in knowledge (e.g., use in pregnancy, long-term use) addressed in RMP and possibly by studies.

Risk that has been observed (e.g., in trials or post-marketing) and is in labeling.

Risk suspected but not yet confirmed (e.g., from signal); may be in labeling as potential.

Communication (internal or external) about an urgent safety issue (e.g., recall, new contraindication).

Communicating risks to HCPs and patients (e.g., DHCPL, PIL, direct communication).

Restriction of distribution (e.g., certified prescribers, pharmacies) as risk minimization.

FDA REMS component: mandatory elements to ensure safe use (e.g., training, testing).

System to implement REMS (e.g., certification, dispensing documentation).

Plan for communicating safety information (e.g., as part of RMP); may include materials and channels.

Training of HCPs on safe use (e.g., for aRMM); effectiveness may be measured.

Card or leaflet for patients with key safety information (e.g., PPP patient card).

Guide for prescribers with safety and aRMM information.

Overall system for identifying, assessing, and minimizing risks (RMP, aRMM, effectiveness).

Temporary restriction imposed by authority for safety; MAH must comply.

Structured assessment of a safety concern (e.g., from signal) for RMP and regulatory action.

Potential risk that is considered important (e.g., in RMP); may trigger aRMM or studies.

Missing information that is important for safe use; in RMP and may require study.

Plans and procedures for managing PV-related crisis (e.g., major safety issue, recall).

Product recall for safety reason; PV may be involved in assessment and communication.

Same as benefit-risk balance; EU term.

Section of RMP describing safety specification (known/unknown risks, missing information).

Section of RMP describing PV activities (studies, monitoring).

Section of RMP describing aRMMs and effectiveness evaluation.

Revision of RMP when new safety information, signal, or regulatory request; submitted to authority.

Summary of RMP for public or authority; may be published.

Communicating safety information directly to patients (e.g., letter, website).

Same as DHCPL; EU term for direct communication to HCPs.

Materials (e.g., leaflet, card, guide) used in risk minimization; may require approval.

Tool used to minimize risk (e.g., checklist, reminder); part of aRMM.

Programme restricting access to drug (e.g., certified prescribers, registry).

Risk minimization interventions beyond routine labeling, such as educational materials, prescriber guides, or controlled access programs.

A symbol used in the EU to identify medicines under additional monitoring, indicating the need for enhanced adverse event reporting.

A distribution system that restricts access to a medicine to ensure it is only prescribed by qualified prescribers and dispensed to appropriate patients.

Documents or tools designed to inform healthcare professionals and/or patients about specific risks and how to minimize them.

Components of a REMS program that impose access restrictions, such as prescriber/pharmacy certification, patient registries, or dispensing requirements.

A risk for which there is sufficient evidence of an association with the medicinal product based on clinical trial data, post-marketing experience, or nonclinical studies.

FDA-required patient labeling that provides information about drug risks to help patients use medicines safely.

Gaps in knowledge about the safety of a medicine in certain populations or situations, requiring further data collection.

A study conducted after authorization to obtain further information on a medicine's effectiveness in routine clinical practice.

A study conducted after authorization to obtain further information on a medicine's safety, identify risks, or measure effectiveness of risk minimization.

A card given to patients containing critical safety information they should share with all healthcare providers involved in their care.

The section of an RMP describing activities to identify, characterize, or quantify risks, including routine and additional pharmacovigilance activities.

A risk where there is a basis for concern but insufficient evidence to establish a causal relationship, such as class effects or nonclinical findings.

A comprehensive risk minimization program for teratogenic medicines to prevent fetal exposure through pregnancy testing, contraception, and patient counseling.

A detailed description of the pharmacovigilance system used by an MAH, maintained at the QPPV location and available for inspection.

A US FDA-required drug safety program to ensure benefits outweigh risks, which may include medication guides, communication plans, or elements to assure safe use.

Interventions intended to prevent or reduce the probability of an adverse reaction occurring or its severity if it does occur.

The measurement of whether risk minimization measures achieve their intended goals of reducing risk occurrence or severity.

A comprehensive document describing the safety profile, pharmacovigilance activities, and risk minimization measures for a medicinal product.

Standard risk minimization through product labeling, including SmPC, package leaflet, and appropriate pack size.