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Osteoporosis International
Published in: Osteoporosis International 6/2008

01-06-2008 | Editorial

European regulatory perspectives for innovative therapies

Authors: S. Ormarsdottir, J.-Y. Reginster, E. Abadie

Published in: Osteoporosis International | Issue 6/2008

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Abstract

The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased interaction between stakeholders in pharmaceutical development. Development of new, high quality, effective and safe medicines in Europe is the common goal of academia, pharmaceutical industry and regulatory authorities. To achieve this, it is important that regulatory requirements do not hinder innovation and vice versa, innovation cannot be allowed to proceed without concerns for public health. Interaction between stakeholders in pharmaceutical development is of the utmost importance. A dialogue has begun and in the future it will be the responsibility of all stakeholders to ensure continuous exchanges in an environment that is characterised by new scientific advances and global development programmes.
Literature
1.
2.
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Official Journal L 91, 9/4/2005 p. 13–19). http://​ec.​europa.​eu/​enterprise/​pharmaceuticals/​eudralex/​
3.
4.
Reginster JY (2007) The efficacy of glucosamine sulfate in osteoarthritis: financial and nonfinancial conflict of interest. Arthritis Rheum 56:2005–2010CrossRef
5.
Bresalier RS (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. NEJM 352:1092–1102CrossRefPubMed
6.
7.
8.
Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘ clinical superiority’ (Official Journal L 103, 28/4/2000 p. 5 – 8). http://​ec.​europa.​eu/​enterprise/​pharmaceuticals/​eudralex/​
9.
10.
11.
Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises (Official Journal L 329, 16/12/2005 p. 4 – 7). http://​ec.​europa.​eu/​enterprise/​pharmaceuticals/​eudralex/​
12.
13.
14.
15.
Abadie E, Ethgen D, Avouac B, et al. (2004) Recommendations for the use of new methods to assess the efficacy of disease-modifying drugs in the treatment of osteoarthritis. Osteoarthr Cartil 12:263–268CrossRefPubMed
16.
17.
18.
Reginster JY, Gieschke R (2006) Clinical utility of a pharmacostatistical model for ibandronate in postmenopausal osteoporosis. Curr Drug Metab 7:827–836CrossRefPubMed
19.
20.
21.
22.
Reginster JY, Abadie E, Delmas PD, Rizzoli R, Dere W, der Auwera P, Avouac B, Brandi ML, Daifotis A, Diez-Perez A, Calvo G, Johnell O, Kaufman JM, Kreutz G, Laslop A, Lekkerkerker F, Mitlak B, Nilsson P, Orloff J, Smillie M, Taylor A, Tsouderos Y, Ethgen D, Flamion B (2006) Recommendations for an update of the current (2001) regulatory requirements for registration of drugs to be used in the treatment of osteoporosis in postmenopausal women and in men. Osteoporos Int 17:1–7CrossRefPubMed
23.
World Medical Association declaration of Helsinki (1997) Recommendation guiding physician and biochemical research involving human subjects. JAMA 277:225–226
24.
Delmas PD, Calvo G, Boers M, Abadie E, Avouac B, Kahan A, Kaufman JM, Laslop A, Lekkerkerker JF, Nilsson P, Van Zwieten-Boot B, Kreutz G, Reginster JY; Group for the Respect of Ethics and Excellence in Science (GREES) (2002) The use of placebo-controlled and non-inferiority trials for the evaluation of new drugs in the treatment of postmenopausal osteoporosis. Osteoporos Int 13:1–5CrossRefPubMed
25.
Silverman SL, Cummings SR, Watts NB; for the Consensus Panel of the ASBMR, ISCD, and NOF (2008) Recommendations for the Clinical Evaluation of Agents for Treatment of Osteoporosis: Consensus of an Expert Panel Representing the American Society for Bone and Mineral Research (ASBMR), the International Society for Clinical Densitometry (ISCD), and the National Osteoporosis Foundation (NOF). J Bone Miner Res 23:159–165CrossRefPubMed
26.
Metadata
Title
European regulatory perspectives for innovative therapies
Authors
S. Ormarsdottir
J.-Y. Reginster
E. Abadie
Publication date
01-06-2008
Publisher
Springer London
Published in
Osteoporosis International / Issue 6/2008
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI
https://doi.org/10.1007/s00198-008-0576-4

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