Traduction de «Comité d'examen des drogues nouvelles » (Français → Anglais) :

(a) the examination of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002, C.08.002.1 or C.08.003 of the Food and Drug Regulations, an application in respect of an establishment licence under those Regulations or an application for a drug identification number under section C.01.014.1 of those Regulations;

32. Observes that the Authority is repeatedly challenged over alleged cases of conflicts of interest involving members of the experts' panels, especially in the case of the panels on 'Food additives and nutrient sources added to food' (ANS) and 'Genetically modified organisms' (GMO); underlines that eight of the Authority's panels and its scientific committee were due for renewal in March 2012 and that the Authority's capability of implementing the new policy is under scrutiny; calls therefore on the Authority to inform the discharge authority in writing by 30 June 2012 of the steps undertaken to implement the new policy on independenc ...[+++]e and scientific decision-making processes and to conform to the OECD definition of conflict of interest when renewing its panels and its scientific committee; at the same time, calls on the Authority to inform the discharge authority of the new composition of the panels and of the scientific committee by 30 June 2012;

31. Observes that the Authority is repeatedly challenged over alleged cases of conflicts of interest involving members of the experts' panels, especially in the case of the panels on ‘Food additives and nutrient sources added to food’ (ANS) and ‘Genetically modified organisms’ (GMO); underlines that eight of the Authority's panels and its scientific committee were due for renewal in March 2012 and that the Authority's capability of implementing the new policy is under scrutiny; calls therefore on the Authority to inform the discharge authority in writing by 30 June 2012 of the steps undertaken to implement the new policy on independenc ...[+++]e and scientific decision-making processes and to conform to the OECD definition of conflict of interest when renewing its panels and its scientific committee; at the same time, calls on the Authority to inform the discharge authority of the new composition of the panels and of the scientific committee by 30 June 2012;

11. Awaits the mid-term review of EIB external financing by 30 April 2010 and the Commission proposal for a new decision replacing Decision No 633/2009/EC; takes the view that both the mid-term review and the new Commission proposal should take into account not only the recommendations of the steering committee chaired by Michel Camdessus, but also the previous recommendations of Parliament; calls in particular for greater consistency in the EIB's external mandate, as regards both the sufficiency of funds for the whole period of the new mandate and their distribution by geographical areas;

11. Awaits the mid-term review of EIB external financing by 30 April 2010 and the Commission proposal for a new decision replacing Decision No 633/2009/EC; takes the view that both the mid-term review and the new Commission proposal should take into account not only the recommendations of the steering committee chaired by Michel Camdessus, but also the previous recommendations of Parliament; calls in particular for greater consistency in the EIB's external mandate, as regards both the sufficiency of funds for the whole period of the new mandate and their distribution by geographical areas;

9. Believes that the creation of a Committee of European Regulators should lead to better and more consistent implementation of legislation and faster convergence between different rules across the EU; believes, for example, that there is a much greater chance of attaining convergence or eventual harmonisation of conduct of business and advertising rules if regulators work closely together in a new EU committee of the type proposed by the Lamfalussy Group; peer review, benchmarking and the spread of ...[+++]best practice will be enhanced by the new structure and should drive forward the convergence process;