European Directorate for the Quality of Medicines Company Profile

04:55 EDT 20th September 2018 | BioPortfolio

The EDQM was created in 1996 and is a Directorate of the Council of Europe. Its premises have been especially designed for its various activities. Today the EDQM is organised into nine administrative entities. Each plays a specific role.Our Vision'To be a world leader in the establishment of high quality standards for human and veterinary medicinal products recognised throughout Europe, and covering the entire range of raw materials used to produce these medicines which are of common interest to European countries'.
Mission of the EDQM
To contribute to the basic human right of access to good quality medicines and thus promote and protect human and animal health by:
- establishing and providing users with official standards for the manufacture and quality control of medicines applicable in all the signatory states of the Convention for the elaboration of a European Pharmacopoeia,
- setting up privileged collaboration with observer states at the European Pharmacopoeia Commission, and
- organising a network of Official Medicines Control Laboratories to collaborate and share expertise.

News Articles [2652 Associated News Articles listed on BioPortfolio]

Revised Guideline On Quality Of Biosimilar Medicines Open For Comments

The European Medicines Agency has released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines.

A pioneering conference will address the threat of poor quality medicines on a global scale

A pioneering academic conference will bring together, for the first time, people from all over the world dealing with the problem of poor quality medicines and their impact on public health... The pos...

First two CAR-T cell medicines recommended for approval in the European Union

The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel...

Canadian Zinc Oxide Company GHC First In America To Receive European Certification

European CEP And GMP License Combine To Further Validate GHC As The Premier Choice For Pharmaceutical Customers Seeking Zinc Oxide SAINT-HYACINTHE, Quebec (PRWEB) August 16, 2018 G.H. Chemicals (GHC)...

Availability of orphan medicines varies between European countries

(University of Eastern Finland) There are differences in the availability of orphan medicines between different European countries, a new study from the University of Eastern Finland shows. The study ...

Six new therapies backed for EU approval

Six medicines have taken a big step towards European approval having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

European Medicines Agency Scales Back In Preparation for Brexit

As Britain’s “Brexit” from the European Union moves closer and closer, the European Medicines Agency (EMA), the equivalent to the U.S. Food and Drug Administration (FDA), temporary halted some o...

European Medicines Agency Authorizes Deferral of Paediatric Investigation Plan for Trogarzo

Theratechnologies (TSX:TH) announced that the Paediatric Committee of the European Medicines Agency has accepted to defer the initiation of the Paediatric Investigation Plan for Trogarzo after the app...

Drugs and Medications [316 Associated Drugs and Medications listed on BioPortfolio]

Terbinafine hydrochloride [Aurobindo Pharma Limited]

These highlights do not include all the information needed to use terbinafine hydrochloride safely and effectively. See full prescribing information for terbinafine hydrochloride tablets.Terbinafine H...

Oxygen [Quality Home Healthcare, Inc. ]


Fluconazole [Aurobindo Pharma Limited]

Hydrogen peroxide [Worldwide Sales & Distribution Corp.]

Quality Guaranteed Hydrogen Peroxide Solution

Cimetidine [Walgreen Company]

Walgreen Co. Cimetidine 200 Drug Facts

PubMed Articles [4070 Associated PubMed Articles listed on BioPortfolio]

Quality control programmes for veterinary antimicrobial medicines.

The health benefits of the antimicrobial's use is inherently associated to the risk of antimicrobial resistance (AMR), an ever-increasing multifactorial problem, closely related with injudicious use o...

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines.

Biological medicines nowadays have a great impact, as they offer treatment for  diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active subst...

Quality specifications for articles of botanical origin from the United States Pharmacopeia.

In order to define appropriate quality of botanical dietary supplements, botanical drugs, and herbal medicines, the United States Pharmacopeia (USP) and the Herbal Medicines Compendium (HMC) contain s...

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates th...

A quality improvement project to increase self-administration of medicines in an acute hospital.

A patient survey found significantly fewer patients reported they had self-administered their medicines while in hospital (20% of 100 patients) than reported that they would like to (44% of 100). We a...

Clinical Trials [3210 Associated Clinical Trials listed on BioPortfolio]

Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)

The aim of this study is to adapt and validate to the Spanish the European Quality Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically ill and dying ...

PENTA Fosamprenavir Study

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above...

European Compliance Study in Parkinson's Disease

In both symptomatic and asymptomatic disease, only about half of medicines are taken as prescribed1. Relatively little is known about how patients with Parkinson's disease take their medi...

Pilot Program to Personalize Care & Improve Quality of Life for Women With Ovarian Cancer

The purpose of this study is to find out if complementary and alternative medicines (CAM) should be included with traditional therapy for women with ovarian cancer. Some of the alternative...

A Comparison of European and Chinese Blood Sugar Responses

This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow Europ...

Companies [1728 Associated Companies listed on BioPortfolio]

European Directorate for the Quality of Medicines

The EDQM was created in 1996 and is a Directorate of the Council of Europe. Its premises have been especially designed for its various activities. Today the EDQM is organised into nine administrative...

The Directorate for Nature Management (DN)

The Directorate for Nature Management (DN) is a national body that has the scientific responsibility for managing the Norwegian countryside. It is responsible to the Ministry of Environment on matters...

European Generic medicines Association

The EGA is the official representative body of the European generic pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to millions of Europeans and stimu...

European Medicines Agency

European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London.ts main responsibility is the protection and promotion of public and animal health, through t...

EU-Japan Centre

Commission (Directorate-General for Enterprise & Industry) and the Japanese Ministry of Economy, Trade and Industry (METI). The Centre has been established as a core non-profit organisation for foster...

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