Get General European Omcl Network Geon Quality Management Document

The EDQM protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. The standards set by the EDQM are recognised scientific benchmarks and are applied in Europe and beyond.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

The Standard Terms database gives the equivalents of over 900 terms in 35 world languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Irish, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, ...

Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).

Under both the EMEA and the FDA, the drug development process includes preclinical testing; clinical trials with phase 1, 2, and 3 testing; and a final approval procedure. In the United States, an investigational new drug application is filed with the FDA for drugs that appear safe in the preclinical phase.

The Commission of the European Union (EU) and the Council of Europe decided on 26 May 1994 to create a network of official medicines control laboratories (OMCLs). This network amounted to a new collaboration in the area of quality control of marketed medicinal products for human and veterinary use.