Glossary

The centralised procedure is a process for obtaining marketing authorisation for a medicine in the EU. The European Medicines Agency (EMA) oversees the centralised authorisation procedure for human and veterinary medicines. This procedure results in a single marketing authorisation, granted by the European Commission, which allows a medicine to be marketed in all EEA (European Economic Area) countries (EU member states and the three EEA EFTA States: Iceland, Liechtenstein, and Norway).

Division of the Canadian Cardiology Institute of Montreal that promotes personalised medicine. http://www.cepmed.com/"

Chemistry, Manufacturing, and Control

Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells. Chemotherapy is used along with surgery, radiation therapy, or biological therapy. It works by stopping or slowing the rapidly growing cancer cells. However, chemotherapy can also harm healthy cells that divide quickly, such as those that line the mouth and intestines. Due to the effect these medicines have on healthy cells, serious or severe side effects are common.

A chronic condition is a long-lasting disease that can be controlled but not cured. The term chronic is usually applied when the course of the disease lasts for more than three months.

Common chronic diseases include asthma, chronic obstructive pulmonary disease (COPD), cancer, and diabetes. In certain diseases or conditions, prevention is effective in reducing the possible development of the condition or its effect. Early diagnosis and timely treatment can help to reduce serious effects of the condition.

Class effect refers to the similar outcomes, therapeutic effects and similar adverse effects of two or more medicines. All products within a class are assumed to be closely related in three concepts: a similar chemical structure, mechanism of action, and pharmacological effects.

In the EU there are two classifications of medicinal products for human use:

1. medicinal products subject to medical prescription
   
2. medicinal products not subject to medical prescription
   

Further subcategories may exist on a national level.

Clearance is a term in pharmacokinetics which describes the volume of plasma that is completely cleared of a substance per unit time. The usual units are mL/min. The total body clearance will be equal to the renal (kidney) clearance + hepatic (liver) clearance + lung clearance although for many medicines the clearance is simply considered as the renal excretion ability.

Clinical development is one step in the process of bringing new medicines or treatments to the market. Based on non-clinical research (microorganisms/animals), it refers to clinical trials, which are done in people. They follow different phases designated as Phase I, II, III (and IV after marketing authorisation).

As a component of a dossier submitted for HTA assessment, clinical effectiveness is a measure of how well a particular treatment works in the practice of medicine. It depends on the application of the best knowledge derived from research, clinical experience, and patient preferences.