European Medicines Agency

Established in 1995. Based in the Seat area of London , UK . The EALS arose after more than seven years of negotiations between the governments of the EU member states. He replaced the “Committee on Proprietary Medicines”, founded in 1977, and the “Committee on Veterinary Medicines”. Later, however, the last two institutions revived as the basis for scientific advisory committees.

November 20, 2017 in connection with the British exit from the European Union , a decision was made to move the agency’s headquarters from London to Amsterdam ^{[3] [4]} .

EALS acts in the EU as a decentralized scientific institution (as opposed to any regulatory body of the European Union) and is responsible for the protection and promotion of human and animal health, directly by coordinating the assessment and tracking of centrally and nationally registered drugs, developing technical guidelines and providing scientific advice to clinical trial organizers .

The scope of activities carried out by the EALS includes pharmaceuticals for humans and animals, including biological preparations, preparations for therapeutic plasma filtration, as well as preparations from medicinal plants. The Agency consists of the Secretariat (Executive Committee), scientific committees (each of which is for drugs for humans, for animals, for drugs from medicinal plants, as well as for rare drugs) and working scientific groups.

EALS is organized in four divisions:

• drugs for humans;
• animal preparations and inspections;
• communications and network services;
• administrative staff.

The EALS includes 4 special committees:

• The Executive Committee carries out administrative oversight of the entire agency: including the approval of budgets and plans, the election of an Executive Director. The committee includes two members from each member state, two from the European Economic Community and two from the European Parliament.

For drugs subject to central registration, or requiring it, the pharmaceutical company submits documents in order to obtain a registration certificate directly to the EALS.

• The Human Medicines Committee (CLCR) or the Animal Medicines Committee (CLCR) conducts a single assessment. If the relevant committee concludes that the quality, safety and efficacy of the drug has been proven sufficiently, it will make a positive decision. The latter, sent to the European Commission, must be embodied in a registration certificate valid throughout the European Union.
• The Rare Drugs Committee (RLCD) at the EALS gives individual drugs the status of rare drugs.
• The fourth committee in the EALS is the Medicinal Herbs Committee (CPLC). It contributes to harmonization procedures and proposals made in the EU Member States regarding medicinal herbal products and the further integration of medicinal herbal products into the European regulatory system.
• In July 2007, a committee was formed at the EALS to deal with new legislation on pediatrics in Europe (the “Pediatric Committee”). Starting in July 2008, all appointments for applying for a registration certificate for new pharmaceutical products must include data from studies on children (previously only agreed with the PC), or demonstrate rejection of claims or cancellation of such studies by the PC. Starting in January 2009, these responsibilities apply to most variations of already registered drugs (for example, new indications for prescribing).

European counterparts:

• Committee for Medicinal Products for Human Use (CHMP)
• Committee for Medicinal Products for Veterinary Use (CVMP)

Most existing drugs in all EU member states continue to receive national registration, but the vast majority of genuine originals are registered with the EALS.

The agency has approximately 500 employees and decentralizes its scientific evaluation of pharmaceuticals through a network of approximately 3,500 experts across the EU. EALS draws on the resources of the National Competent Authorities (NPOs) of the EU Member States. According to the Regulations, the Committee on medicinal products for humans and the Committee on medicinal products for animals are required to reach decisions within 210 days, but this limit is stopped if it becomes necessary to request additional supporting data from the Submitter. This is better than the average 500 days required by the U.S. Food and Drug Administration.

In the Russian Federation, similar activities are carried out by the Federal Service for Supervision of Health and Social Development . The authority of the service includes:

• supervision of pharmaceutical activities, supervision of the production, manufacture, quality, effectiveness, safety, turnover and use of medicines;
• supervision of the import into the Russian Federation of medicines and their export;

EuroVigilance - Pharmacovigilance of the European Union

• European Medicines Agency
• European Directorate for the Quality of Medicines