Appendix A

Glossary

Accountability: The result of the process which ensures that health actors take responsibility of what they are obliged to do and are made answerable for their actions.

Active pharmaceutical ingredient: Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Confidentiality commitment: A document that sets up the legal framework for a regulatory authority to share certain kinds of nonpublic information with regulatory counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities.

Conformity assessment: A systematic examination to determine the extent to which a product, process, or service fulfills specified requirements.

Conformity assessment body: A body engaged in the performance of procedures for determining whether the relevant requirements in technical regulations or standards are fulfilled.

Effectiveness: The extent to which a specific intervention, procedure, regimen or service, when deployed in the field in routine circumstances, does what it is intended to do for a specified population.

Efficacy: The extent to which a specific intervention, procedure, regimen or service produces the intended result under ideal conditions.

Event: A specific identifiable happening or occurrence (e.g., the taking of a medicine; the experience of an adverse effect).

Falsified medical products: Medical products that deliberately/fraudulently misrepresent their identity, composition, or source.

Findings: See Inspection observation.

Good clinical practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies. It provides assurance that the data and results that are reported are credible and accurate.

Good distribution practice (GDP): Describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

Good manufacturing practice (GMP): The part of quality management that ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization, or product specification.

Good pharmacovigilance practice (GPvP): Provides guidance for the appropriate oversight of products once they have been released onto the general market.

Inspection observation: A finding or statement of fact made during an inspection and substantiated by objective evidence. Such findings may be positive or negative. Positive observations should take the form of a description of the processes that the firm is carrying out particularly well and that may be considered as examples of particularly good practice. Negative observations are findings of noncompliance with requirements.

Medicinal products: In this report, a term that encompasses medicines and vaccines.

Monitoring: The continuous process of collecting and analyzing data to compare how well a project, program, or policy is being implemented against expected results.

Performance indicators: Measurable values used to quantify quality objectives to reflect the performance of an organization, process, or system, also known as “performance metrics” in some regions.

Post-marketing: The stage when a drug has been approved and is generally available on the market.

Promotion: All informational and persuasive activities by manufacturers and distributors, the intended effect of which is to induce the prescription, supply, purchase, and/or use of medicinal products.

Quality assurance: Is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections.

Recognition: The routine acceptance by the regulatory authority (RA) in one jurisdiction of the work products and regulatory decisions of another RA or other trusted institution.

Regulatory authority: See Regulatory system.

Regulatory framework: The collection of laws, regulations, guidelines, and other regulatory instruments through which a government controls the manufacture, clinical evaluation, marketing, promotion, and postmarketing safety benchmarking of medical products.

Regulatory system: The system composed of entities responsible for the registration, marketing authorization, and other regulatory functions concerning medical products. The number of regulatory entities responsible for different regulatory functions may vary from one country to another (i.e., the regulatory authority may or may not be a single entity). The terms national medicines regulatory authority (NMRA) and/or drug regulatory authority (DRA) are also used, although less encouraged, to designate the national regulatory authority.

Reliance: The act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to (i.e., totally or partially rely on work products by another regulatory authority or trusted institution in reaching its own decision). The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.

Substandard and falsified medicines: Authorized medicines that fail to meet either their quality standards or their specifications, or both.

Substandard medicines (also called “out of specification”): Authorized medicines that fail to meet either their quality standards or their specifications, or both.

Unilateral reliance: A lower-resourced authority that bases its decision on the work product of a well-resourced authority.

Work sharing: The act whereby two or more medicines regulatory agencies agree to work together on a specific regulatory activity. Such work sharing may be on a reactive ad hoc basis or an established proactive routine basis. Such work sharing may result in a common decision.