European Commission Launches Consultation on Pharmaceuticals

European CommissionThe European Commission has launched a consultation on the future of pharmaceuticals for human use in Europe, as a part of its programme to improve the regulatory, non-regulatory and research, technology and development framework for pharmaceuticals. In an explanatory note, the Commission highlights three major challenges impacting the pharmaceutical sector in Europe: the globalisation of the sector; the smooth functioning of the internal market; and advances in science and technology.

On globalisation, the Commission notes that "due to structural factors which go beyond the pharmaceutical sector (e.g. labour costs), the centre of gravity for worldwide R&D investment in the field is gradually moving to the United States and Asia."

Regarding the internal market, the Commission notes that there are still obstacles to the free movement of medicines. Furthermore, the Commission notes that the safety of medicines is a major internal market issues. "Recent analysis has demonstrated the existence of multiple and sometimes inefficient requirements as regards pharmacovigilance in the EU," the Commission writes. "The challenge is thus to strengthen and rationalise drug safety monitoring, while avoiding unnecessary requirements that would impair patients' access to treatments."

Another trend affecting the pharmaceutical sector is the increasingly proactive role of patients regarding their health, and the Commission notes that patients need better access to quality information.

Finally, the Commission identifies advances in sciences and technology such as regenerative medicine, more personalised treatments and the development of nanomedicines, which are all affecting the way medicines are tested and eventually prescribed.

Key questions asked by the Commission concern other challenges to the industry, such as what measure could be implemented to ensure the safety of medicines supplied to the EU, how to improve Europe's international competitiveness and how the EU regulatory framework can be applied to emerging technologies.

For further information, please download (.pdf):
http://ec.europa.eu/enterprise/pharmaceuticals/
pharmacos/docs/doc2007/2007_07/consultationpaper-2007-07-19.pdf

The closing date for contributions is 12 October 2007.

Copyright ©European Communities, 2007
Neither the Office for Official Publications of the European Communities, nor any person acting on its behalf, is responsible for the use, which might be made of the attached information. The attached information is drawn from the Community R&D Information Service (CORDIS). The CORDIS services are carried on the CORDIS Host in Luxembourg - http://cordis.europa.eu. Access to CORDIS is currently available free-of-charge.

Most Popular Now

Aspirin green light for brain bleed stroke patient…

People who suffer a stroke caused by bleeding in the brain - known as brain haemorrhage - can take common medicines without raising their risk of another stroke, a major ...

Cancer cells are quick-change artists adapting to …

Until now, researchers have assumed that the growth of solid tumors originates from cancer stem cells characterized by specific surface markers, which develop in a fixed...

APRINOIA Therapeutics awarded grant from The Micha…

APRINOIA Therapeutics, a clinical-stage biotechnology company with a pipeline of therapeutics and imaging diagnostics for neurodegenerative diseases, announces today that...

Benralizumab not effective reducing exacerbations …

More than 15.3 million people in the U.S. suffer from chronic obstructive pulmonary disease (COPD), which is the third leading cause of death in this country, according t...

Pfizer announces top-line results from Phase 3 Tri…

Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age wi...

Novartis phase II data for new inhaled combination…

Novartis announced today that new phase II data for IND/GLY/MF (QVM149), an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol ac...

Cannabis use among older adults rising rapidly

Cannabis use among older adults is growing faster than any other age group but many report barriers to getting medical marijuana, a lack of communication with their docto...

New data show Symbicort reduces attacks in mild as…

New data from Novel START, an open-label trial designed to reflect real-world practice, has demonstrated the effectiveness of Symbicort Turbuhaler (budesonide/formoterol)...

Merck pioneers new effort to see MS from the insid…

Merck, a leading science and technology company, joins the global multiple sclerosis (MS) community in recognition of World MS Day, an initiative created by the Multiple ...

Amgen joins with community oncology networks for n…

Amgen (NASDAQ: AMGN), along with leading community oncology networks, today announced the launch of Amgen Community Oncology Research Collaborators (ACORC), a new initiat...

Bayer receives U.S. FDA breakthrough therapy desig…

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for copanlisib (Aliqopa™) for the treatment of adult patie...

Novartis Kisqali significantly extends life in wom…

Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated K...