Translation of "Parcelle d'essai de longue durée " (French → English) :

These include understanding the molecular basis of disease, the identification of innovative therapeutic strategies and novel model systems, the multidisciplinary application of knowledge in physics, chemistry and systems biology, the development of long-term cohorts and the conduct of clinical trials (including focus on the development and effects of medicines in all age groups) , the clinical use of ‘-omics’, systems biomedicine and the development of ICT and their applications in healthcare practice, notably e-health.

vaccine potency testing characterised by persistent impairment of the animal’s condition, progressive disease leading to death, associated with long-lasting moderate pain, distress or suffering.

The maximum storage time for individual procedures cannot yet be determined owing to the lack of empirical data from long-term experiments (e.g. in the case of the cryoconservation of living cells and tissue).

9. Urges Member States and the Commission to recognise and endorse the view that the cost-effectiveness of drug therapies used for patients with multiple sclerosis and other long-term chronic diseases should be measured not only through clinical trials but also through an assessment of improvement in the quality of life afforded by new treatment, which could have positive implications for savings in other sectors of social or welfare budgets;

8. Urges Member States and the European Commission to recognise and endorse the view that the cost-effectiveness of drug therapies used for patients with Multiple Sclerosis and other long-term chronic diseases should be measured not only through clinical trials, but also through an assessment of improvement in the quality of life afforded by new treatment which could have positive implications for savings in other sectors of social or welfare budgets;

tests assessing the potential risks posed by the medicinal product for the environment. A detailed description of the in-house pharmacovigilance and risk-management system which the applicant has introduced. Proof that the clinical trials conducted with the medicinal product meet the ethical requirements of Directive 2001/20/EC. As a rule, this excludes the recognition of clinical trials carried out in a developing country unless the medicinal product concerned primarily benefits the population of that country. Results of appropriate long-term tests on medicinal products intended for long-term use.