Traduction de «Essai de phase I de nouveaux médicaments » (Français → Anglais) :

The law also aims to simplify and speed up procedures authorising these trials which are vital for developing new medicines and improving treatments using existing medicines.

There is a need to support the improvement of cross-cutting support technologies for drugs, biotherapies, vaccines and other therapeutic approaches, including transplantation, surgery, gene and cell therapy and nuclear medicine; to increase success in the drug and vaccine development process (including alternative methods to replace classical safety and effectiveness testing, e.g. the development of new methods); to develop regenerative medicine approaches, including approaches based on stem cells; to develop new biopharmaceuticals, including therapeutic vaccines; to develop improved medical and assistive devices and systems; to imp ...[+++]rove palliative therapies; to maintain and enhance the ability to combat disease and undertake medical interventions that depend on the availability of effective and safe antimicrobial drugs; and to develop comprehensive approaches to treat co-morbidities at all ages and avoid poly-pharmacy.

Projects include development of: (i) new anti-retroviral treatments to overcome growing resistance of the virus; (ii) new interventions for the treatment of HIV-infected infants, pregnant women and adults; (iii) HIV microbicides to allow women that do not have the capacity to impose HIV prevention measures (safer sex through condom use) on their partners to protect themselves against HIV transmission; (iv) new and promising HIV vaccine candidates not only to prevent the HIV infection, but also to treat infected people; (v) new anti-HIV drugs against hidden virus that can not be accessed by other drugs, and against the ...[+++]escape of the virus from infected cells, (vi) vaccine delivery systems to fight viruses; and (vi) specific support actions for standardising clinical tests and monitoring HIV resistance.

In addition, in order to facilitate the testing of new medicinal products while guaranteeing a high level of protection for consumers, sufficiently long withdrawal periods should be laid down for foodstuffs that animals involved in tests might produce.

EDCTP brings together EU Member States plus Norway, African countries, international donors and the pharmaceutical industry in a joint effort to combat these three poverty-linked diseases by facilitating and accelerating phase II phase III clinical trials for new drugs and vaccines.

More concretely, new medicines or vaccines emerging from clinical research may prove highly promising in preliminary small-scale clinical trials but may not be developed further into market products in the absence of sufficient funds and/or facilities for the necessary large-scale trials.