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Glossary

Advanced Therapy medicinal products

Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burn victims, Alzheimer, cancer or muscular dystrophy.

Better regulation / Cutting Red Tape

Cutting red tape is the process of reducing unnecessary bureaucracy. The EU is committed to developing a better regulatory environment for businesses - one that is simple, understandable, effective and enforceable. Cutting red tape should help business people and entrepreneurs improve competitiveness, as well as contribute to sustainable development.

CHMP

Committee for Medicinal Products for Human Use

Clinical Trials

Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products.

Communication on the future of the pharmaceutical sector

The Communication on the future of the pharmaceutical sector adopted on 10 December 2008 by the European Commission outlines the major health, economic and scientific challenges of Europe and the pharmaceutical industry, sets out a vision for the future of the sector and proposes deliverables for the years with 25 different measures on various topics.

COMP

Committe for orphan Medicinal Products

CVMP

Committee for Medicinal Products for Veterinary Use

EDQM

Department for the Quality of Medicines and Healthcare

eHealth

eHealth tools or solutions include products, systems and services that go beyond simple Internet-based applications, for instance tools for health authorities and professionals, and personalised health systems for patients and citizens. eHealth can help to deliver better care for less money within citizen-centered health delivery systems and has been identified as one of the six relevant Lead Market Initiative for Europe.

EMEA

European Medicines Agency

G10

The G10 High Level Group on Innovation and Provision of Medicines was the key political initiative in the field of pharmaceuticals under Commissioners Byrne (Health) and Liikanen (Industry). The Group of ten was intended to bring together the top decision-makers on medicines from the EU and discussed the major issues relevant to the right balance of health objectives and industry competitiveness in Europe, including provision of medicines to patients, Single Market, competition, regulation and innovation.

G10 Medicines

High Level Group on Innovation and Provision of Medicines

GCG

International Conference on Harmonisation Group

GMP

Good Manufacturing Practices

Good Manufacturing Practice

Good Manufacturing Practice (GMP) are quality standards that have been set up by the European Union to ensure that medicinal products are consistently produced and controlled against the quality standards appropriate to their intended use. Compliance with these principles and guidelines is mandatory.

Health Technology Assessment

The importance of Health Technology Assessment (HTA), which seeks appropriate spending and use of health technologies has been a constant theme over the last 20 years. Based on the conclusions of the High Level Pharmaceutical Forum and on the experience of EUnetHTA project, the Commission is engaged in the preparation of a Joint Action on Health Technology Assessment under the Public Health Work Plan for 2009. Please visit the dedicated webpage for Health Technology Assessment of Health and Consumers Directorate-General.

Herbal Medicinal Products

Herbal medicinal products are defined as any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.

High Level Group on Innovation and Provision of Medicines

The G10 High Level Group on Innovation and Provision of Medicines was the key political initiative in the field of pharmaceuticals under Commissioners Byrne (Health) and Liikanen (Industry). The Group of ten was intended to bring together the top decision-makers on medicines from the EU and discussed the major issues relevant to the right balance of health objectives and industry competitiveness in Europe, including provision of medicines to patients, Single Market, competition, regulation and innovation.

High Level Pharmaceutical Forum

The Pharmaceutical Forum, concluded on 2 October 2008, was a three-year process, set up in order to find relevant solutions to public health considerations regarding pharmaceuticals, while ensuring the competitiveness of the industry and the sustainability of the national health-care systems. This high-level ministerial platform for discussion between Member States, EU institutions, industry, healthcare professionals, patients and insurance funds focused its work on three main topics: Information to patients on diseases and treatment options; pricing and reimbursement policy and relative effectiveness.

HMA

Heads of Medicines Agencies

HTI

Health Technology Assessment

ICH

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IMI

Innovative Medicines Initiative

Information to Patients

To ensure adequate information to patients on diseases and treatment options, the European Commission has been looking at different ways of improving the quality and accessibility of information within the High Level Pharmaceutical Forum and with the adoption of legal proposals on information to patients.

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a crucial element of the European Commission's innovation policy. The objective of this instrument, a public-private partnership involving the industry and the Commission, is to enhance and accelerate the development process of medicines so as to make new treatment options available to patients earlier.

Lead Market Initiative for Europe

The Lead Market Initiative is one of the most important innovation policies in the EU, involving Member States, industry, NGOs and the European Commission.

LMI

Lead Market Initiative

Maximum Residue Limits

Maximum Residue Limits refer to the maximum concentration of residue resulting from the use of a veterinary medicinal product which may be accepted by the Community to be legally permitted or recognized as acceptable in or on food.

MRL

Maximum Residue Limits

MRP

Mutual Recognition Procedure

NtA

Notice to Applicants

Orphan medicinal products

Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union.

PEDCO

Paediatric Committee

Pharmaceutical Committee

The Pharmaceutical Committee is an advisory Committee, which is responsible for examining all questions relating to proprietary medicinal products and, in particular, the preparation of proposals for Directives.

Pharmacovigilance

Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines.

Pricing and Reimbursement

Decisions concerning the prices and reimbursement status of medicines fall within the competence of the EU Member States. However, these decisions have a tremendous impact on the functioning of the internal market and on the competitiveness of the pharmaceutical industry. The European Commission therefore works with all stakeholders in order to develop balanced and adequate pricing and reimbursement policies across Europe.

Referral

A referral is a procedure used to resolve disagreements and address concerns. In a referral, the EMEA is requested to conduct, on behalf of the European Community, a scientific assessment of a particular medicine or class of medicines. The medicine, or the class or medicines, is 'referred' to the CHMP, so that the Committee can make a recommendation for a harmonised position across the European Union.

Transparency Directive 89/105/EEC

Council Directive 89/105/EEC lays down harmonised provisions to ensure the transparency of national provisions regulating the pricing and reimbursement of medicinal products. It is commonly referred to as the "Transparency Directive".

Variations

All changes subsequent to their placing on the EU market of medicinal products, as for example changes in the production process, the packaging and the address of the manufacturer, are considered in legal terms as 'variations', and must be handled according to a complex legislative framework: the 'Variations Regulation'.

VICH

International Conference on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

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