Glossary: EU Glossary

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Adaptive Pathway

The adaptive pathway seeks to balance timely access for patients who are likely to benefit most from the medicine with the need to provide adequate evolving information on the benefits and risks of the medicine itself, bringing the drug to market through iterative phases of evidence gathering and licensing, with further approval of adjustments based on post-market trials and real-world evidence.

Advanced Therapy Medicinal Products (ATMP)

The term Advanced Therapy Medicinal Products (ATMP) is applied to products involving cells, genes or tissues. For example, many regenerative medicines, personalised treatments and nanomedicines can be considered ATMPs.

CE Mark

A CE mark is the manufacturer’s declaration that the product meets the health, safety and environmental protection requirements of the applicable European Standards. The actual words signified by “CE” have been disputed. It is often taken to be an abbreviation of Conformité Européenne, meaning “European Conformity”.

Clinical Governance

A system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish.

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Committee for Advanced Therapies (CAT)

The Committee for Advanced Therapies is part of the European Medicines Agency (EMA). It is the committee responsible for assessing the quality, safety and efficacy of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapies.

Committee for Medicinal Products for Human Use (CHMP)

The committee responsible for preparing the Agency’s opinions on all questions concerning medicines for human use, in accordance with Regulation (EC) No 726/2004. The CHMP plays a vital role in the marketing procedures for medicines in the EU and publishes a European public assessment report (EPAR) for every centrally authorised medicine that is granted market authorisation.

Committee for Medicinal Products for Veterinary Use (CVMP)

The committee that is responsible for preparing the Agency’s opinions on all questions concerning veterinary medicines. The CVMP plays a vital role in the marketing procedures for medicines in the European Union.

European Economic Area (EEA)

Established on the 1st January 1994, the EEA includes the countries of the EU (European Union) plus Iceland, Liechtenstein and Norway.

European Medicines Agency (EMA)

The EMA is a decentralised agency of the European Union responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

European Public Assessment Report (EPAR)

A published report by the European Medicines Agency (EMA) with detailed information on medicines assessed by the Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) for every human or veterinary medicine application that has been granted or refused a marketing authorisation.

ISPOR

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), an international organisation promoting the science of pharmacoeconomics and health outcomes research.

Marketing Authorisation

An authorisation to market a medicinal product from the European Medicines Agency (EMA) or the European Commission or from additional bodies specific to each countries such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

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Marketing Authorisation Holder (MAH)

The MAH stands for the company in whose name the marketing authorisation has been granted. This party has responsibility for all aspects of the product, including quality and compliance with the conditions of the marketing authorisation.

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Orphan

A term designated to rare diseases and drugs that treat such diseases. The prevalence of the condition must not exceed 5 in 10,000 in order to be classified as an orphan within the EU but may vary in other non-EU countries.

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Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC is the committee at the European Medicines Agency (EMA) that is responsible for assessing and monitoring safety issues for human medicines.

PRAC’s recommendations are considered by the CHMP when it adopts opinions for centrally authorised medicines and referral procedures when it provides a recommendation on the use of a medicine in the Members States.

Ultra-Orphan

The term given to drugs that are used to treat extremely rare diseases that are chronically debilitating or life-threatening, with a prevalence of less than 1 in 50,000.

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