Some terms in the Pharmaceutical Sector-2

EDL (Essential Drugs List-Essential Drugs List)
Model List of Essential Drugs DSÖ'nün, in developing countries to ensure a reasonable amount of drugs available has been created in the 1970s. Essential Drugs, the majority of the population consists of drugs that meet medical needs. Adequate amounts and proper dosage should always be accessible. Model List of Essential Drugs DSÖ'nün developing countries identify their priorities and make choices to medication. Model in the list of drugs DSÖ'nün more than 90% of the non-patent drugs is, therefore, almost close to zero by the law firm at a cost generic copies should be considered.

EMEA (European Agency for the Evaluation of Medicinal Products - European Agency for Evaluation of Medical Products)
Evaluation of the European Medical Products Agency, the European Medicines Agency is now called, began operations in 1995. Agency based in central London, the European Union member states and to assess the human and veterinary medicinal products and to check the existing scientific resources of Member States to coordinate.

EPAR-(European Public Assessment Report). European Public Assessment Report
Center for Medical Products Committee for Proprietary end process (Committee for Proprietary Medicinal Products - CPMP) reached by the final decision includes scientific. At the same time, the report, be specific in the direction of a medical license to the product of reason to explain the CPMP decision.

GATT (General Agreement on Tariffs and Trade - General Agreement on Tariffs and Trade)
In 1947, signed by 117 states is a comprehensive free trade agreement. GATT'ın aim, to promote world trade and global economic growth to contribute to supervise. Many of the issues, as well as all other member countries, member countries of import and export tariffs to the same act, the member countries based on the editor to provide copyright protection, trade-related issues to consult with each other and differences in a peaceful way to resolve is encouraging. With GATT, the agreements to ensure compliance to the WTO (World Trade Organization - WTO) was created with the name recognition of the regulatory body.

Generic - Generic
Non-patent drugs. A drug, the patent only until the end of the drug, manufactured by the company can be discovered. After the patent ends, any company is entitled to the same generic compound is produced.

Genes - Genes
Genes, the DNA carried by chromosomes from each other than to create individual is responsible for separating hereditary characteristics. Every human being has an estimated 100,000 separate genes. More generally the 'genes' of the term person has certain features can be used in relation to the transfer and inheritance.

Gene Therapy - Gene Therapy
Organisms with a genetic disease of the damaged gene is replaced with another gene. To isolate the gene and the functioning of cells is used to place rekombinan DNA techniques. People with more than 300 single-gene genetic disorders have been identified. These are an important part of gene therapy may be appropriate for.

Genome - Genome
The total of the genes carried by individuals or cells.

Genomics - Genome science
Genes and functions viewing is the name given to the sciences. Recent progress in genome science, the complex interaction of genetic and environmental factors, including the molecular mechanisms of disease to create a revolution in the information. In addition, genome science, the development of drugs for the thousands of new biological targets revealed by scientists and new medicines, vaccines and DNA diagnosis of innovative ways to create a revolutionary health by providing products to the discovery motion was passed. Genome science-based treatment between the "traditional" small chemical drugs, protein drugs and, potentially, gene therapy is available.

GCP (Good Clinical Practice - Good Clinical Practice)
Human subjects participated in the research design, execution, recording and reporting related to international ethical and scientific quality standards are. These standards, work safety and health of the subjects were taken under guarantee, to comply with principles of the Helsinki Declaration and reliable data for clinical research is to reassure the public.

GMP (Good Manufacturing Practice - Good Manufacturing Practice)
In accordance with Good Manufacturing Practices regulations, all drug producing companies in Europe, is the control of production processes. Production facilities, are required to comply with the rules check.
In the U.S. Hatch-Waxman Act out of the Hatch-Waxman Act (1984) through the generic drugs more widely available with the leading companies continue to develop new drugs for a balance between the incentives provided were established. Generic companies, the approval process for the patent with fewer early start have the right to violate. Since the date of the adoption of the Law of the generic drug market has increased at a rate of almost 50%.

Health - WHO definition - Health - DSÖ'nün Definition
Health, not only has an illness or weakness, a complete physical, mental and social wellbeing is a state. 152nd of the Treaty on European Union According to Article: "Community policies and activities relating to definition and application of human health at high levels will be supervising."

Health Outcome - Health Results
Health (or other) as a result of the provision of services in health status (mortality and morbidity) changes occur.

Health Outcomes Research - Health Outcomes Research
A specific medication, direct, indirect and non-tangible benefits and value-added benefits, including the young discipline / methodology is. According to the pharmaceutical industry, only the quality, reliability and efficiency should concentrate on such issues in the license approval process ( "farmakoekonomi" or "cost-effectiveness studies" is also referred to as) is not appropriate view.

HMO (Health Maintenance Organization - Health maintenance organization)
What you have received health care in a health plan that is followed. Managed care, you and your health plan participating in the coordination of health professionals are governed by the health plan. Are the most common management HMO'lar care plan.

Hormone - Hormones
Hormones, are molecules produced by a gland or tissue. Usually the blood moving through the hormones, in a distant organ or tissue effects. For example, the pancreas produces insulin, insulin also regulates the level of sugar in the organism. Hormones, nervous system, including the human body that coordinates the activities of billions of cells.
ICH (International Conference on harmonization - International integration / harmonization Conference)
Human Medical Products Licenses Technical Terms Relating Harmonizasyonuna International Conference (ICH), product license for the scientific and technical matters to discuss Europe, Japan and the U.S. and by licensing authorities of the three regions in the pharmaceutical industry professionals together is an important project. The purpose of the conference, product licenses and conditions relating to the interpretation of technical manuals and more harmonization in the implementation of recommendations for ways to provide.

Incidence - incidence
Number of new patients each year are affected disease.

Informed consent - Informed Olur
Participate in clinical research required to be informed that the concept of patient participation in clinical research on a reasonable decision to provide doctors / physicians and patients about the information (for example, potential risks, benefits, and alternatives) on the task is based on the principle.

INN
Put in place a molecule of activity is useful, it is an INN name (international non-proprietary name - an international non-proprietary name is not on) is given. This name is given according to international rules as are adopted and the World Health Organization affiliated to the approval of a special committee will be.

Innovation - Innovation
New products (innovative product) formation, in production to reduce costs (process innovation), or presented to the patient that a product's therapeutic value, which led to increased technological süreçtir.Yenilikler, new active ingredients in existing products and new indications of the same products use different ways can reveal.

International exhaustion of International Property Rights - International Intellectual Property Rights to be consumable in the International
Bölgesellik of rights based on the principles of this theory under the protection of a product of any country, the first legal sales after the product-related intellectual property rights owner of this product to another country (again) to be issued the right to restrict the loss means.

In Europe, the international rights to the policy in force is not exhausted. Community in that the depletion regime of rights to trademarks registered in the EU according to the region from outside the EU is a registered trademark owners of the branded goods imported within the Community can deny. The same situation applies to patented goods.

However, EU officials, European Union, under the protection of goods between Member States can move freely in a region considered to be one and unified. Accordingly, parallel imports within the EU territory will be granted.

IPRs (Intellectual Property Rights - Intellectual Property Rights)
In Law, patent, copyright and trademark laws, including the ownership and use of creative work is the edited field. Intellectual property rights, have submitted works to the benefit of humanity and the creative person or companies, without the approval of work to copy or mimic has been developed to protect against.

LDC (Least Developed Countries). The less developed countries (currently 49 countries).
Developing countries are scattered according to income levels: high-income, middle income, low income (see UNCTAD)

Medicinal Product - Medical Products
EU law, medical products, people or animals to treat disease or to prevent any substance or combination of substances is expressed as. People or animals or people in the medical diagnostics to recover physiological functions, correction or replacement of any substance or substances used in combination is considered as medicinal products.
For further information: drug regulation in the framework of Directive 65/65/EEC specifies the URL 2001/83/EEC amending the Directive to see.

MedDRA
(Medical Dictionary for Regulatory Activities Terminology)
Licensing Activities Terminology attached to the Medical Dictionary.
This vital medical resources International Conference on harmonization (ICH) and has been developed by the International Federation of Pharmaceutical Manufacturers Association (International Federation of Pharmaceutical Manufacturers Association - IFPMA) aittir. By providing a single source of medical terminology MedDRA, the medical products worldwide licensing activities related to increasing the effectiveness and transparency.

MEP
(Member of the European Parliament). (Short) Member of the European Parliament.
Millennium Development Goals (MDGs) - the Millennium Development Goals
The United Nations Millennium Summit in September 2000 adopted the Millennium Development Goals to the serious level of poverty reduction and improving the health of low income were found in the call. Identified goals and objectives, "the elimination of poverty on development and the creation of an environment" that are committed represents a partnership between developed countries.

Morbidity - morbidity
A specific disease in a specific region of the relative frequency.

Mortality - mortality
The number of deaths that occur within a specific period of time.

Mutual Recognition - Mutual Recognition
According to this procedure, provided by Member States of the license applicants in line with the preferences in one or more other Member States to apply. This procedure applies to most conventional drugs.

NGO - NGOs
Non-Governmental Organization.

NME-new Mokeküler Article
(New molecular entities). New molecular materials: human disease to be eliminated, to be alleviated, treatment, prevention or in vivo diagnostic use for the people of earlier treatment is not available and only if the prescription is presented as the targeted products (new chemical substances (ncesi - new chemical entities) biological products , including vaccines and biotechnology products).

ROOMS
(Official Development Assistance). Official Development Assistance

[size = 14t] Orphan Drug - Orphan Drug [/ size]
With a limited target population or to treat a rare disease, so the drugs are limited commercial and financial potential. The first time in the USA (1983) Orphan Drug Act entered into force in helping these patients and the drugs trade in terms of development to make it possible to provide incentives (and the exclusive market research expenses for the tax credit) has been developed for. In Europe, the Regulation on Orphan Medical Products more then (December 1999), "rare" as classified in the European Union and more than 10,000 people from around 5 in 5000 affecting illness diagnosis, prevention and treatment in the EU for the development of drugs entered into force for the purpose of animation.

OTC (Over the counter - Tezgahüstü Drugs)
Available is used for prescription drugs.

Outpatient Care - Foot Treatment of
Outpatient treatment services provided in clinics or emergency and medical services do not need to spend the night in hospital.