Pharmaceutical and Healthcare Europe

From the simple pill to the most sophisticated treatment, all medicines manufactured and sold in Europe are subject to strict standards, covering quality, safety and efficacy issues. The Council of Europe’s work deals with the quality control of medicines in Europe as well as with specific areas of healthcare.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe is in charge of these activities. The Convention on the Elaboration of a European Pharmacopoeia was finalised by the Council of Europe in 1964 and laid down the foundation for the drafting of common quality standards in Europe.

QUALITY CONTROL OF MEDICINES

Quality of medicines

The European Pharmacopoeia is a collection of quality standards (also named “monographs”) applicable to all medicines. Tests to be carried out on medicines and raw materials used in the production of medicines are described in details. These quality standards are legally binding and compliance is mandatory in order to obtain a marketing authorisation from a national or European authority. They cover a wide range of active substances and excipients used to prepare medicines and include general texts on biological substances, herbal drugs, antibiotics, vaccines as well as dosage forms and containers.

From the beginning a close cooperation with the European Union (EU) and other partner organisations was established to promote the implementation of a coherent regulatory framework that satisfies public health needs.

The Certification Procedure of the EDQM

It concerns the evaluation of the quality of substances for pharmaceutical use with respect to the criteria prescribed in the relevant European Pharmacopoeia monograph(s). A manufacturer of a substance submits a detailed file to the EDQM that describes the manufacturing process and the tests performed on the raw material and the substances used in their product. Recognised by 37 signatory states of the European Pharmacopoeia Convention and by the EU, over 4000 CEPs have been granted in more than 50 countries.

Control of medicines

Programmes for surveillance of marketed medicines (The OMCL Network)

The EDQM co-ordinates the network of Official Medicines Control Laboratories (OMCLs). The Network was established in 1995 at the request of the EU with the purpose of harmonising practices and facilitating mutual recognition of quality control tests carried out on medicines to ensure that patients receive the same quality of pharmaceutical products throughout Europe.

Approximately 80 OMCLs from 30 countries are now involved in implementing testing programmes.

Official control laboratories in brief

  • Independent public laboratories appointed by the national authorities
  • 30 European countries participate in the various activities of the network
  • 80 laboratories or OMCLs pool human and technical resources to implement testing programmes
  • About 500 products were tested by the network in 2010
  • About 10 000 certificates are issued by the network every year
  • About 150 counterfeit or illegal product testing reports were issued in 2010

 

 
 

HEALTHCARE ACTIVITIES

Blood and organ donation

Blood transfusion as well as organ donation and transplantation, pharmaceutical care issues and the fight against counterfeit medicines: these issues are of importance in our daily life and can benefit from programmes of activities developed and managed by the EDQM at international level:

Elaboration of guidance and standards in the fields of blood transfusion and organ transplantation

The blood transfusion and the transplantation of organs, tissues and cells work programme are built around three major principles: the voluntary, non-remunerated donation, self-sufficiency and protection for both the donors and the recipients.

The non-commercialisation use of products of human origin and the fight against organ trafficking is one of our priorities.
 

BLOOD TRANSFUSION IN BRIEF

ORGAN TRANSPLANTATION IN BRIEF


 

 
  • 2013: 17th Edition of the Guide to the preparation,
    use and quality assurance of blood components
  • 61 experts from member states
  • 2011: 16th edition of the Guide to the preparation,
    use and quality assurance of blood components
  • 2010/2011: pilot phase for setting up a central
    database on stocks of frozen blood
    available for international exchange.
  • 46 experts from 31 member states
  • 2011: 4th edition of the Guide to safety and quality
    assurance for the transplantation of organs, tissues
    and cells
    - Publication of a Transplant Newsletter
  • Reports, recommendations and resolutions sent to the Member states of the Council of Europe

 

Other activities

Pharmaceutical care and pharmaceutical practices comprise the following activities:

 - Classification of medicines as regards their supply;

 - Quality and safety standards in pharmaceutical practices and pharmaceutical care.
  

Preventing and managing risks posed by counterfeit medical products and similar crimes to patients

- Models and approaches are elaborated to enable networking between officials from health and law enforcement agencies across borders, appropriate risk communication, the timely identification of harm caused by such products, and builds up intelligence and specific knowledge. A specific multidisciplinary training programme has been developed in which, to date, more than 100 officials from 40 countries in Europe and beyond have participated.

 - A new international treaty of  importance: the Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health MEDICRIME Convention has been opened for signature and the EDQM will support its follow-up and implementation. The above Convention is the first international treaty which criminalises counterfeiting of medical products and similar crimes with a view to public health protection.


Consumer health in Europe

These activities are aimed at improving consumer health in Europe, in particular, by harmonising testing practices and the approaches used in the various member states to guarantee the quality and safety of cosmetic products and packaging materials for food and pharmaceutical products.