Health-EU Newsletter - A new way forward for clinical trials

Issue 95, 6 September 2012

In this edition


New rules for clinical trials

By Stefano Soro, Head of Unit, European Commission, Medicinal products – quality, safety and efficacy, Directorate-General for Health and Consumers

On 17 July 2012 the Commission adopted a proposal for a 'Clinical trials Regulation'.


Clinical trials are tests of medicines in humans. They give patients access to most innovative treatments and are vital to develop medicines and to improve and compare the use of already authorised medicines. Clinical trials, the backbone of clinical research, are crucial to save or improve the quality of many lives every year.


The proposed Regulation, once adopted, will replace the 'Clinical Trials Directive' of 2001. This Directive has already ensured a high level of patient safety, but its divergent transposition and application led to an unfavourable regulatory framework for clinical research, thus contributing to a decrease of 25% of clinical trials launched in the period between 2007 (more than 5 000) and 2011 (3 800).


The new legislation will take the form of a Regulation. This will ensure that the rules for conducting clinical trials are identical throughout the EU while maintaining the highest standards of patient safety and robustness and reliability of data.


In particular, it will make it easier to conduct multinational clinical trials in Europe. Some concrete proposals are:


• An authorisation procedure for clinical trials which will allow for a fast and thorough assessment of the application by all Member States concerned and which will ensure one single assessment outcome.

Simplified reporting procedures which will spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States.

More transparency on whether recruitment for participating in a clinical trial is still ongoing, and on the results of the clinical trial.

• The possibility for the Commission to conduct controls in Member States and other countries to make sure the rules are being properly supervised and enforced.


It is foreseen that the new legislation will better benefit citizens and make sure that clinical trials are conducted to the highest standard across all EU Member States.

News from the EU

Opinion on fragrance allergens in cosmetics published

The opinion issued by the Scientific Committees on Consumer Safety (SCCS) concerns perfuming ingredients in cosmetic products which can cause allergic reactions in consumers.

New EU Cosmetics Directive makes hair dyes safer

With an estimated 60% of women colouring their hair, sales of hair dye products in the EU are rising steadily. The EU Cosmetics Directive aims to ensure that such products contain only safe substances.

Subscribe to OSHmail to keep up with occupational health news!

The European Agency for Health and Safety at Work (EU-OSHA) launched an electronic newsletter dedicated to occupational safety and health in the EU and the world. The newsletter is published on a monthly basis and available in 24 languages.

Study reveals how early diet impacts mental development

EU-funded NUTRIMENTHE project is a 5-year programme to study exactly how and why diet can impact on the mental development and performance of children.

Portal for rare diseases and orphan drugs gets a makeover

Orphanet, the European portal for rare diseases and orphan drugs, has a new fresher design. It contains information in French, English, German, Portuguese, Spanish and Italian, primarily for health professionals working with rare diseases patients.

Get all the facts about X-ray full-body scanners for airport security

Some types of scanners already used in the USA, which expose passengers to low levels of X-rays, are not yet authorised in the EU because of concerns about potential health risks. How safe are such X-ray security scanners?

Reporting from across Europe


Ambitious investment in telemedicine

The Danish government has earmarked DKK 80 million (about EUR 10 million) for a national action plan on telemedicine in order to offer high standard healthcare services to patients wherever they are in the country.


Services for the elderly on the increase

Despite the economic crisis, Maltese authorities are increasing services offered to the elderly. They are also conducting a survey on elderly needs and care, involving more than 9 000 respondents. Survey findings will help the government to shape its future policies in this sector.

Forthcoming Events

22nd Alzheimer Europe Conference (Vienna, 4-6 October 2012)

This year's conference will be about ‘Changing perceptions, practice and policy’ to help improve the quality of life of dementia patients and their carers.

Complementary and alternative medicine – Innovation and added-value for European healthcare (Brussels, 9 October 2012)

The conference will be hosted by MEP Elena Oana Antonescu and is organised with the support of the European Public Health Alliance. EU Commissioner for Health and Consumer Policy, John Dalli, will deliver a video message.

European MedTech Forum 2012 (Brussels, 10-12 October 2012)

The conference is jointly organised by the European industry associations, Eucomed and the European Diagnostic Manufacturers Association. This year’s edition will focus on 'Europe leading in value-based innovation – Smart regulation as a catalyst for growth'.

2012 European scientific conference on applied infectious disease epidemiology – ESCAIDE (Edinburgh, 24-26 October 2012)

The conference, organised by the European Centre for Disease Prevention and Control (ECDC), provides an opportunity for public health scientists, epidemiologists, microbiologists and other professionals to share experiences and knowledge.

New Publications

New report on rare diseases in Europe for 2012

The European Union Committee of Experts on Rare Diseases (EUCERD) has produced the 2012 report on the state of the art of rare diseases activities in Europe.

Drug and alcohol use: EU report reviews measures for creating safer nightlife environment for young people

EU drugs agency (EMCDDA) has published a new report and a factsheet recommending measures to promote healthy behaviour amongst young people when going out to party.


Clinical Trials

Activities at EU level

Medicinal products for human use – Clinical trials

European Commission – DG Health and Consumers

Health-EU – Medicines and Treatment

European Commission – DG Health and Consumers

European Medicines Agency

European Commission – DG Health and Consumers


Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines

On 17 July, the Commission issued a proposal to simplify existing rules for conducting clinical trials. This will in turn boost clinical research in Europe and give patients access to the most innovative treatments.

Proposal for a clinical trials regulation – questions and answers

What are clinical trials? Who conducts clinical trials? What legislation is in place to regulate clinical trials? Why is the Commission proposing to replace this legislation? We have the answers!

European Medicines Agency: Proactive publication of clinical trials data – discussing the way forward

The European Medicines Agency is organising a workshop on clinical trial data and transparency. The objective is to gather views of stakeholders to help the Agency define the modalities of proactive access to clinical trial data. Registration open until 31 October 2012.

EU Health Prize for journalists – Articles

557 articles submitted to the EU Health Prize for Journalists 2012!

394 journalists from all the 27 EU countries submitted 557 eligible articles which will now be examined by the national juries. News on the national finalists will be published in October.

Health Programme Projects

Quality of Life and Symptom Research in Cancer Clinical Trials (QOL EUROPE)

The conference will be held at the European Parliament on 17-19 October 2012. It will examine the importance of using a patient’s perception and experience when undergoing new clinical trials.

Other interesting links

EudraCT database

International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (WHO)

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

Health-EU. The Public Health Portal of the European Union
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