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

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron ...

Vividion Therapeutics names Jenna Goldberg as Chie…

Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision the...

Bayer with continued strong performance

The Bayer Group maintained its strong business performance across all three divisions in the third quarter. "Despite rising inflation and global supply chain problems, we...

Sanofi and GSK's next-generation COVID-19 booster …

After the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for VidPrevtyn® Beta, the vaccine was approved by t...

GSK announces positive Phase IIa study results for…

GSK plc (LSE/NYSE: GSK) announced positive results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well t...

Sugar molecules as a target in cancer therapy

Cancer cells use sugar molecules on their surface to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism ...

COVID vaccination improves effectiveness of cancer…

Patients with nasopharyngeal cancer are often treated with drugs that activate their immune system against the tumor. Until now, it was feared that vaccination against Co...

Making melanoma immortal: Pitt scientists discover…

Scientists at the University of Pittsburgh School of Medicine have discovered the missing puzzle piece in the mystery of how melanoma tumors control their mortality. I...

Unusual type of antibody shows ultrapotent activit…

An unusual type of antibody that even at miniscule levels neutralizes the Zika virus and renders the virus infection undetectable in preclinical models has been identifie...

New drug shows promise for fighting both COVID-19 …

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot ...

Machine learning can help predict patient response…

Predicting which patients will respond well to treatment is a quandary that has plagued the field of cancer immunotherapy for more than four decades. Now, researchers at ...

Study reveals vaccine confidence declined consider…

A new study suggests that, despite the success of the COVID-19 vaccination campaigns, vaccine confidence has declined significantly since the start of the pandemic. Re...