Advanced therapies Medicinal Products Regulation:
Advanced therapies offer new hope for cancer patients

In 2007, the European Commission has proposed new rules concerning advanced therapy medicinal products. The draft European Parliament and Council Regulation has the  overall policy objective to improve patients’ safe access to advanced therapies by increasing the research, development and authorisation of gene therapy, somatic cell therapy, and tissue engineered products.
Commission proposal advanced therapy medicines

The new EU Regulation on advanced therapies was published in December 2007. It will apply from 30 December 2008. A Regulation means that it will become uniformly law and not be open to any interpretations at national level. The European Commission has now published a call for expressions of interest which relates to the appointment by the Commission of members and alternates representing clinicians and patients' associations (Deadline was 14th of March 2008).

ECPC's newsflash on the publication of the new EU Regulation on advances therapies (Jan 08)

ECPC Position

The proposed regulations offer new hope for cancer patients through the use of tissue engineering, gene therapies and cell-based therapies. Patients are looking for treatment which is safe, effective and of reliably high quality. This is why ECPC supports the Commission’s proposal for a robust EU regulatory framework which will promote good science and protect patients, whilst leaving Member States the flexibility to make ethical decisions.

ECPC's newsflash on the publication of the new EU Regulation on advances therapies (Jan 08)
ECPC's Press Release on the EP vote for Advanced Therapies (April 07)
ECPC’s position in full (Feb 07)
Joint Patient Group Statement (Mar 07)
ECPC background brief on Advanced Therapies