Traduction de «médicaments d'action » (Français → Anglais) :

Question No. 609 Ms. Anne Minh-Thu Quach: With respect to drug regulation and approval: (a) does the 2012 Economic Action Plan provide for decreases or increases in the financial and human resources allocated to (i) drug approval services, (ii) regulatory activities to evaluate and monitor the safety, efficacy and quality of drugs before and after they enter the marketplace, (iii) activities related to the review of submissions by drug manufacturers for market authorization and post-market changes, (iv) activities related to enforcing compliance with existing regulations, including those concerning clinical trials, drug manufacturing and ...[+++] the reporting of adverse drug reactions, (v) activities of the Patented Medicine Prices Review Board, (vi) services such as the Patent Register, Drug Product Database, Notice of Compliance, and Progressive Licensing Project, (vii) various areas of Health Canada such as the Marketed Health Products Directorate, Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, and the Veterinary Drugs Directorate; (b) for each of the programs and directorates listed in (a), (i) what is the estimated extent of the decreases or increases in human or financial resources, (ii) are positions expected to be cut and, if so, how many will be eliminated; (c) was a value-for-money assessment conducted for the drug approval process; and (d) what is the government’s financial allocation plan regarding drug regulation?

Action n° 6: To promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antibiotics to patients by: Launching rapidly with EFPIA[12], within the IMI-Joint Undertaking, a programme for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge. Establishing an overarching framework agreement with the industry, defining objectives, commitments, priorities, principles and modes of action for public-private collaboration in a longer term perspective. Mobilising adequate resources, within IMI in particular (and its possible successor), FP7 ...[+++] and in the longer term the forthcoming research and innovation programme 2014-2020 (Horizon 2020), in order to support research and development work, based on criteria and modalities adapted to the specific needs and challenges of antibiotic development. Use the flexibility in the current pharmaceutical legislation to give rapid authorisation to new antibiotics and work with stakeholders and the Member States' authorities towards the establishment of adequate market and pricing conditions for new antibiotics. Ensure conditions for and implement fast track procedures for the marketing authorisation of new antimicrobials.

First, given that a generic drug can take from two to five years to develop and prove, encouraging the provision of medicines from their most immediate source (the patentee) was viewed as consistent with the underlying policy objective of getting medicines to those in need as quickly as possible.

2. The marketing authorization holder shall be obliged to notify the Member States forthwith of any action taken by him to suspend the marketing of a veterinary medicinal product or to withdraw a product from the market, together with the reasons for such action if it concerns the effectiveness of the veterinary medicinal product or the protection of public health.

- MUTUAL RECOGNITION OF THE VALIDITY OF MEDICAL PRESCRIPTIONS IN THE MEMBER STATES "THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Whereas, in its Resolution of 30 November 1995 on the integration of health protection requirements in Community policies, the Council considers that the Community must pay particular attention to the impact on health of action proposed in a number of areas, including free movement of goods; Whereas action to improve understanding of and address the imp ...[+++]act on human health of the free movement of goods, in particular the free movement of medicinal products, should form part of the Community's overall strategy for action in the field of public health; Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; Whereas patients, in moving from one Member State to another, could in practice be prevented from purchasing medicinal products prescribed by an authorized medical practitioner in another Member State; Whereas, pursuant to the Treaty and to Directive 93/16/EEC, all discriminatory treatment based on nationality with regard to establishment and provision of services is prohibited in medical practice; Whereas this Resolution does not affect provisions governing the financing or reimbursement of the cost of medicinal products by national social security schemes; Whereas, moreover, this Resolution does not cover prescriptions for a non-exempt dose of a substance classified as a narcotic drug or psychotropic substance under United Nations international conventions, CALLS on the Commission, in cooperation with the Member States and taking account of work in this area by the relevant international organizations, to look into the present position with regard to the mutual recognition of medical prescriptions in the Member States.

The person responsible for the marketing of a medicinal product shall be obliged to notify the Member States concerned forthwith of any action taken by him to suspend the marketing of a product or to withdraw a product from the market, together with the reasons for such action if the latter concerns the efficacy of the medicinal product or the protection of public health.