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Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 81
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 82
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
×
Page 83
Suggested Citation:"Appendix A: Glossary." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Page 84

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

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 ingredients: 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 non-public information with regulatory counterparts in foreign countries and international organizations as part of cooperative law enforcement or regulatory activities. Conformity assessment: Systematic examination to determine the extent to which a product, process, or service fulfills specified requirements. Conformity assessment bodies: 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. Efficiency: The capacity to produce the maximum output for a given input. 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. PREPUBLICATION COPY: UNCORRECTED PROOFS A-1

A-2 REGULATING MEDICINES IN A GLOBALIZED WORLD Findings: See inspection observation Good clinical practice: 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 practices: 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 practices: Is that part of Quality Management which 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. Guidelines/guidance documents: Non-statutory advisory publications intended to assist those parties affected by legislation to interpret and apply requirements. Information sharing: The act whereby one medicines regulatory agency provides another medicines regulatory agency with information that the first agency has in its possession. Such sharing may be either at the specific request of the receiving agency or may be provided by the first agency of its own volition. Such information-sharing may be either of publicly available information or confidential information. It may also be on a reactive ad hoc basis or on an established prospective routine basis. 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 document, a term that includes 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 is approved and 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 PREPUBLICATION COPY: UNCORRECTED PROOFS

GLOSSARY A-3 products. Ethical criteria for drug promotion, WHO, 1988. For the purposes of this manual, promotion includes advertising. Recognition: The routine acceptance [of work products] by the regulatory authority (RA) in one jurisdiction of the regulatory decision of another RA or other trusted institution. Recognition indicates that evidence of conformity with the regulatory requirements of country A is sufficient to meet the regulatory requirements of country B. Recognition may be unilateral, bilateral, or multilateral, although recognition is usual manifest as the subject of mutual recognition agreement. Regulatory authority: See Regulatory system. Regulatory framework: The collection of laws, regulations, guidelines, and other regulatory instruments through which a government controls medical products manufacture, clinical evaluation, marketing, promotion and post-marketing safety benchmarking. 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, however less encouraged, for designating 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 upon 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. Stakeholders: An individual, group or an organization that has an interest in the organization and delivery of health care. Substandard and falsified products (SF): See Substandard medicines and falsified medicines. Substandard medicines (also called “out of specification”): Authorized medicines that fail to meet either their quality standards or their specifications, or both. 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. 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 on an established proactive routine basis. Such work-sharing may result in a common decision PREPUBLICATION COPY: UNCORRECTED PROOFS

A-4 or recommendation regarding the regulatory activity or it may result in a common document that each agency then uses to inform its individual regulatory decision regarding the regulatory activity. PREPUBLICATION COPY: UNCORRECTED PROOFS

Next: Appendix B: Table of Mutual Recognition Agreements »
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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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