In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA).

and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection.

These common harmonised quality standards – known as monographs – describe strict specifications for medicines and the substances used in their manufacture, that apply throughout the product's entire life cycle.

Commission[14] decides on the work programme,[15] appoints the experts and adopts the monographs and other texts that comprise the Ph.

In addition, the EDQM is responsible for establishing and supplying the official reference standards without which it would be impossible to carry out many of the mandatory quality control tests described in the Ph.

These physical standards are used by manufacturers located both in Europe and around the world, and national and European authorities involved in the quality control of medicines, to name but a few.

[16] Source:[17] The EDQM runs a quality evaluation programme for active ingredients and excipients used in the manufacture of medicines.

[19] Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP)[18] provides proof that the methods used by a manufacturer or distributor result in an product whose quality complies with the requirements laid down in the corresponding Ph.

It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry, thus saving time and resources.

member states[4] and by a number of other countries and regions, including Australia, Canada, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan and Tunisia.

An increasing number of licensing authorities worldwide accept CEPs[18] to support (fully or partially) the data related to the quality of active ingredients used in medicinal products.

As previously stated, a CEP[18] is granted after members of the EDQM's panel of assessors (drawn from national medicines agencies throughout Europe) have reviewed a detailed dossier submitted by the manufacturer.

This dossier describes the manufacturing process and the tests performed on the raw materials and on the substance produced, as well as the necessary in-process controls.

Their primary mission is to ensure, through random sample testing, that medicines supplied to patients – wherever they are in Europe – comply with the applicable quality standards and the terms and conditions of their MA.

The laboratories that form the network share resources, expertise and workloads: this not only contributes to reducing public health expenditure, a broader coverage of medicines on the market and to the development of future harmonised common standards, but means that laboratories across Europe have access to state-of-the-art technology and selective analytical procedures.

The EDQM is responsible for co-ordinating the network's technical activities and ensuring the smooth running of its various joint programmes.

Errors related to medication use, lack of documentation on how medicines are prescribed, used and dispensed, as well as insufficient communication have a considerable impact on national mortality and morbidity rates.

In order to face this challenge while taking into account current constraints on public health budgets and social inequality in access to healthcare, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH),[24] which is co-ordinated by the EDQM, oversees the work of experts in three main areas: The work of the EDQM in the area of blood transfusion is co-ordinated by the European Committee on Blood Transfusion (CD-P-TS),[26] which consists of representatives from authorities working in the field of blood transfusion or at national blood establishments (BEs) from member states of the council of Europe and observers such as the European Commission, WHO, the USFDA and the Council of Europe's Committee on Bioethics (DH-BIO).

This latter principle is fulfilled by improving and promoting strict standards for quality and safety in order to protect not only the donor and recipient, but also the precious donated organ/tissue itself.

Since 1 January 2009, the EDQM has worked on strengthening consumer health protection in Europe, with a focus on the safe use and quality of cosmetics and materials and articles in contact with foodstuffs.

Priority is given to testing products that may present a health risk for consumers, either linked to the presence of prohibited or restricted substances (according to EU legislation) or trace metals.

The technical guides published by the CD-P-MCA[37] are used as reference documents by manufacturers and other business operators, safety evaluators and control laboratories.