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References

Original article

New Drugs

Dtsch Arztebl Int 2012; 109(7): 117-23. DOI: 10.3238/arztebl.2012.0117

Ujeyl, M; Schlegel, C; Walter, S; Gundert-Remy, U

1.Europäische Arzneimittel-Agentur: Zulassung und Überwachung von Arzneimitteln – Europäische Arzneimittel-Agentur: http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/pharmaceutical_and_cosmetic_products/l22149_de.htm#amen dingact. last accessed on 1st June 2011.
2.EMA: Status of EMEA scientific guidelines and European pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products; www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004008.pdf. EMEA/42371/2008; London, 11. September 2008 – corr. last accessed on 1st June 2011.
3.EMA: European public assessment reports: www.ema.europa.eu/ema/index.jspcurl=pages/medicines/general/general_content_ 000433.jsp&murl=&mid=. last accessed on 1st June 2011.
4.Garattini S, Bertele V: The role of the EMEA in regulating pharmaceutical products. In: Mossialos E, Mrazek M, Walley T (eds.): Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality. Open University Press; Maidenhead: European Observatory on Health Systems and Policies Series 2004.
5.Hart D: Risk-benefit evaluation of medicinal products. An element of health technology assessment. Bundesgesundheitsbl – Gesundheitsforsch – Gesundheitsschutz 2005; 48: 204–14.
6. Hoag H: Cancer drugs should add months, not weeks, say experts. Nat Med 2011; 17: 7 CrossRef MEDLINE
7.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) (eds.): Allgemeine Methoden – Version 4.0; www.iqwiq.de/download/IQWIQ_Methoden_Version_4_0.pdf. Köln, 23.09.2011. last accessed on 1st october 2011.
8.Lasser KE, Allen PD, Woolhandler SJ, et al.: Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215–20 CrossRef
9.Waller PC, Tilson HH: Managing drug safety issues with marketed products. In: Talbot J, Waller P (eds.): Stephen’s detection of new adverse drug reactions. 5th Edition. Chichester, West Sussex: John Wiley & Sons Ltd 2004; 345–74.
10.Hess R: Die Frühbewertung des Nutzens neu zugelassener Arzneimittel. GGW 2011; 11: 8–14.
11.Arzneimittelkommission der deutschen Ärzteschaft: Neue Arzneimittel: www.akdae.de/Arzneimitteltherapie/NA/index.html. last accessed on 23 September 2011.
12. Honig PK: Comparative effectiveness: the fourth hurdle in drug development and a role for clinical pharmacology. Clin Pharmacol Ther 2011; 89: 151–6 CrossRef
13.Eudra Lex: EudraLex – Volume 1 – Pharmaceutical legislation
medicinal products for human use: http://ec.europa.eu/health/docu ments/eudralex/vol-1/index_en.htm. last accessed on 1st June 2011.
14.van Luijn JC, Gribnau FW, Leufkens HG: Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Pharmacol 2007; 63: 159–62 CrossRef MEDLINE
15.EMA: Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/01/WC500100710.pdf. EMA/759784/2010; London,
November 2010. last accessed on 23 September 2011.
16.Sorenson C, Naci H, Cylus J, Mossialos E: Evidence of comparative efficacy should have a formal role in European drug approvals. BMJ 2011; 343: d4849 CrossRef MEDLINE
17.AIM, International Society of Drug Bulletins, Medicines in Europe Forum: EMA suggestions on comparative clinical trials fall back behind ethical and scientific standards: www.isdbweb.org/documents/uploads/press/Press_Release2011–03–31.pdf. Brüssel, Bielefeld, Paris, 31. März 2011. last accessed on 23 September 2011.
18.Loke YK, Price D, Herxheimer A: Adverse effects. In: Higgins JPR, Green S (eds.): Cochrane handbook of systematic reviews. Chichester: Wiley-Blackwell 2008; 433–48 CrossRef
19.Stephens M: Introduction. In: Talbot J, Waller P (eds.): New adverse drug reactions. 5th Edition. West Sussex, England: John Wiley & Sons Ltd 2004.
20.Lewis J: Post-marketing surveillance: how many patients? Trends Pharmacol Sci 1981; 2: 93–4 CrossRef
21.EMA: Guideline on the evaluation of anticancer medicinal products in man. CPMP/EWP/205/95/Rev.3/Corr.2; London, 14. December 2005. last accessed on 1st June 2011.
22.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) (eds.): Aussagekraft von Surrogatendpunkten in der Onkologie. Köln: IQWiG 2011.
23.Schwabe U, Paffrath D (eds.): Arzneiverordnungs-Report 2010. Heidelberg, Berlin: Springer Medizin Verlag 2010.
24.Drummond MF: The use of health economic information by
reinbursement authorities. Rheumatology 2003; 42 (Suppl. 3): iii60–iii63 CrossRef MEDLINE
25.Gemeinsamer Bundesausschuss (G-BA): Gemeinsamer Bundesausschuss beschließt erste Festbetragsgruppen unter Einbeziehung patentgeschützter Arzneimittel. www.g-ba/institution/presse/pressemitteilungen/52./Berlin, 15. Juni 2004; last accessed on 1st June 2011.
e1.Head of Medicines Agencies: MRI Product Index: www.hma.eu/mri.html. last accessed on 23 September 2011.
e2.European Agency for the Evaluation of Medicinal Products: Proposal for a European Parliament and Council regulation laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. COM (2001) 404-C5–0591/2001 – 2001/0252 (COD), European Parliament, 2002. www. europarl.europa.eu/sides/getDoc.do?
pubRef=-//EP//TEXT+AGENDA+20021023-LASTV+0+DOC+ XML+VO//EN#items. last accessed on 1st June 2011.
e3.Gemeinsamer Bundesausschuss (G-BA): Arzneimittel-Richtlinie/ Anlage III (Reboxetin): www.g-ba.de/informationen/beschluesse/1186/. Stand: 8. Dezember 2010. last accessed on 23 September 2011.
e4.EMA: What’s New?: www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c4&jsenabled=true. last accessed on 23 September 2011.
e5.Europäisches Parlament: Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates vom 31. März 2004 zur Festlegung von Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur (Text von Bedeutung für den EWR): http://eur-lex.europa.eu/LexUriServ/
LexUriServ.do?uri=CELEX:32004R0726:DE:NOT. (last accessed on 1st June 2011)
e6.EMA: EU Standard of Medicinal Product Registration: Clinical
evaluation of risk/benefit—the role of comparator studies:
www.ema.europa.eu/docs/en_GB/document_library/Position_ statement/ 2009/12/WC500017660.pdf. Doc. Ref. EMEA/ 119319/04; London, 21. Oktober 2004. last accessed on
23 September 2011.
e7.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): [A10–01] Biotechnologisch hergestellte Arzneimittel in der Zweitlinientherapie der rheumatoiden Arthritis: www.iqwig.de/a10–01-biotechnologisch-hergestellte-arzneimittel.986. html?tid=1280&random=198091. Stand: 17. Mai 2011. last accessed on 23 September 2011.
e8.EMA: Points to consider on clinical investigation of medicinal products other than NSAIDs for treatment of rheumatoid arthritis: www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003439.pdf. Doc. Ref. CPMP/EWP/556/95 Rev. 1; London, 17. Dezember 2003. last accessed on 23 September 2011.
e9.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): [A05–07] Nutzenbewertung einer langfristigen, normnahen Blutzuckersenkung bei Patienten mit Diabetes mellitus Typ 2 – Rapid Report: www.iqwig.de/a05–07-nutzenbewertung-einer-langfristigen.986.html?tid=1153. Stand: 5. Juli 2011. last accessed on 23 September 2011.
e10.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): [A05–05A] Glitazone zur Behandlung des Diabetes mellitus Typ 2: www.iqwig.de/a05–05a-glitazone-zur-behandlung-des-diabetes.986.html?tid=1191. Stand: 26. Januar 2009. last accessed on 23 September 2011.
e11.Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG): Osteodensitometrie bei primärer und sekundärer
Osteoporose (Abschlussbericht). IQWIQ-Bericht Nr. 73, 2010. www.iqwiq.de/download/D=/-01_Abschlussbericht_Osteodensitormetrie_bei_primärer_und _sekundaerer_Osteoporose.pdf. last accessed on 1st June 2011.