Some terms in the Pharmaceutical Sector-1

Acquis Communautaire of the Community acquis
Since the founding of the European Union adopted the common law is called the Community acquis. This is the European Union's 15 members signed a contract Devlet'li and contains approximately 80,000-page legislation.

Adherence - Commitment
Patients, in line with the proposed treatment, to what extent compliance with medical instructions and prescription drug use to explain. Developed countries, the general public about the long-term adherence to treatment is around 50%. This rate is much lower than in developing countries.

ADR - Adverse Drug Reaction - Adverse Drug Reaction
Profilaksisi of diseases, diagnosis, or treatment or modification of physiological function of the normal dose used in human medicine against the harmful and desirable means of the reaction.

Antimicrobial resistance - Antimicrobial resistance
Antimicrobial drugs (antibiotics and other antibacterial, antiviral, antifungal and antiparazit substances, including microorganisms to kill or prevent growth to any substance) in the field of health development, the treatment of infectious diseases and prevent infection of the very large extent has contributed. However, excessive or improper use of antibiotics (especially in children with respiratory infections) has led to the development of resistant organisms. Emergence and spread of antimicrobial resistance, the EU and the world, an important public health problem has become.

ATC - ATK
Anatomical, therapeutic, chemical letters of the word starts and an international system used sınıflandırılmasında drugs.

(Benchmarking) - Benchmarking
Benchmarking, to provide superior performance to reach the quest to find best practices sanayiideki.

Biotechnology - Biotechnology
Biotechnology yararlanılabilinmektedir in two ways.
Biotechnology, chemical compounds of living organisms (eg, antibiotics and vitamins) to produce or to change them to open the traditional biological methods. Second, the isolated DNA, copy, cut and re-assembly and DNA from a cell's genes to another based on the technology transfer capabilities to the host. A non-natural ways to change the genetic material and genetically modified organisms have been suffered organisms (GMO) is called.

Blockbuster
Worldwide more than 1 billion dollars is the term used for selling drugs.

Bolar
America, Roche Bolar and between firms of the proceedings with a court order made in watchman-Hatch Act amendments (1984), generic drug manufacturers license preparation for making application for a patent has not yet ended, the use of patented products has made it possible. This amendment, effective patent protection in the United States to provide for measures to be taken there is a part of the political compromise. In Europe, this compromise, SPC (EKB) in the regulations, and restrictions in force to license no more than 15 years. Bolar provision ( "early working" is also referred to as) will become established in Europe means impairment of balance.

Cadreac (Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries - European Union Countries Drug Licensing Authorities Joint Cooperation Agreement Between)
Countries to join the Union as drug licensing authorities informal cooperation between the volunteers. Institutions are represented by directors. Purpose of this cooperation, the participation of institutions in areas of medicine to be eligible for a license to make is to help

Cell - Cell
Cell, is the basic unit of all living organisms. Some organisms live in a state of only one cell. Bacteria and certain animal and plant species in question is of the single cell. The average size of 60-100 trillion cells is a human being. Cells nourish themselves, produce energy, is found in the exchange of information with neighbors and will die when the time comes.

Centralized Procedure - Center Procedures
Medical products, since 1995 can be assessed through Center procedures. This procedure has been approved through the medical products are given a license is valid throughout the EU. Licenses, are given by the European Commission. The medicinal products derived from biotechnological processes for the use of these procedures is mandatory. More innovative products (for example, contains a new active ingredient products) companies or mutual recognition procedure, this procedure may choose to use. Center procedure is used, in London in the European Medical Products Evaluation Agency (EMEA - European Agency for the Evaluation of Medicinal Products) file must be present.

Clinical Trials - Clinical Research
Clinical research, patient's health to improve the reliability and effectiveness of a drug to evaluate the research work carried out on humans. On new drugs and pharmaceutical companies sponsoring clinical research is performed in the compound, including laboratory tests on the (chemical / biological / pharmacological / toxicological), intensive pre-clinical development efforts in successfully pass can start. This test required and only the results reached in the case of promising, companies may try drugs on humans.

Committee for Medicinal Products for Human Use - CHMP - Committee for Human Medical Products
European Medical Products Evaluation Agency (EMEA) under the Registered Medical Products Committee for evaluation of medicinal products for human questions about the scientific committee is responsible for preparing the Agency's views. The Committee is appointed by the Member States consists of 30 members.

Compassionate Use - Early Access Program for Humanitarian Purposes to medication
Medicine without a license is given to patients before the humanitarian situation.

Compulsory Licensing - Compulsory Licensing
TRIPs agreement, without the consent of the patent owner (for example, in emergency cases), states, solid, depending on conditions, the production or sale of a product that allows you to include provisions.

Counterfeit pharmaceutical - Counterfeit medicines (DSÖ'nün definition)
Identity and / or in terms of resources and fraud in order to know the wrong labels are counterfeit drugs. Taklit expression, can be used for both branded and generic products. Counterfeit products:
1) contains the right materials;
2) contains the wrong materials;
3) do not contain active ingredients;
4) that contain active ingredients in the wrong amount, or
5) packaging the product may be counterfeit.

CRO (Clinical Research Organization) - Clinical Research Organization
And clinical research of the pharmaceutical industry providing services organization specialized in the execution.

Daly-(Disability-adjusted Life Year) - Disability and life last year
Potential life lost due to premature death and disability due to lost years of productive by combining the creation of a disease refers to the total load. That a healthy life in a Daly is lost.

Data Exclusivity-Data Protection (also referred to as Data Protection) - (is also referred to as the Data Protection)
Proprietary information belonging to drugs, new drugs for effectiveness and reliability of the scientific research to reveal, and a license obtained from the authorities to get the licensing proprietary (confidential) information. Data protection period, a company related to a specific clinical data on medicinal products can protect their rights while. At that time, another company for making this data can not use generic drug license application. Data exclusivity, the TRIPs Agreement, Article 39.3 in accordance with an independent intellectual property rights protection is acquired.

Data Privacy - Data Privacy
Medical history and personal health data without the explicit approval of the individual, such as unexplained or individual information that can not be used for transfer.

Differential Pricing - Different Pricing
Sometimes "progressive pricing," with equity pricing "or" preferential pricing "is also referred to as. All of these terms, the poorest countries of the world by purchasing power is used to describe the principle of price adjustment.

Disease - Disease
In the general situation of the body or certain organs and vital functions that occur in the performance of the divider or parasitic disease is to change.

Doha Declaration - Doha Declaration
World Trade Organization (WTO) at the Doha (Qatar) 14 November 2001 at the Ministerial Conference adopted the "Declaration on the TRIPs Agreement and Public Health" stop. Provided more flexibility in the existing TRIPs Agreement makes clear that the developing countries to address national issues in providing emergency healthcare to the TRIPs Agreement, the commitment of member states to the WTO.

DTCI (Direct-to-Consumer Information - Consumer Direct Information
Is prohibited in Europe, the Direct to Consumer Promotion (Direct-to-Consumer Advertising - DTCA) In contrast, the pharmaceutical industry, all patients consult with their doctor of the health issues in the knowledge-based decision-making as possible to provide true, accurate and easy to understand access to the information you have been accepted . Europeans, including pharmaceutical companies, all sources have access to quality medicines. (see "Information for Patients").