ヒト用医薬品委員会 Committee for Medicinal Products for Human Use
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出典(authority):フリー百科事典『ウィキペディア(Wikipedia)』「2017/03/25 15:18:27」(JST)
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"CHMP" redirects here. For the French language Canadian radio station, see CHMP-FM.
The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.
References
External links
- European Medicines Agency - Committee for Medicinal Products for Human Use (CHMP)
- Committee for Medicinal Products for Human Use (CHMP)
UpToDate Contents
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English Journal
- Regulatory landscape for cell therapy - EU view.
- McBlane JW1.
- Biologicals : journal of the International Association of Biological Standardization.Biologicals.2015 May 19. pii: S1045-1056(15)00032-9. doi: 10.1016/j.biologicals.2015.04.004. [Epub ahead of print]
- This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled a
- PMID 25997566
- Implementing quality by design for biotech products: Are regulators on track?
- Luciani F1, Galluzzo S, Gaggioli A, Kruse NA, Venneugues P, Schneider CK, Pini C, Melchiorri D.
- mAbs.MAbs.2015 May 4;7(3):451-5. doi: 10.1080/19420862.2015.1023058.
- Quality by design (QbD) is an innovative approach to drug development that has started to be implemented into the regulatory framework, but currently mainly for chemical drugs. The recent marketing authorization of the first monoclonal antibody developed using extensive QbD concepts in the European
- PMID 25853461
- Contribution of the Spanish Agency for Medicines and Healthcare Products to the European Committee for the Evaluation of Medicinal Products for Human Use.
- Alonso-Gutiérrez A1, Díaz-Ramos P2, Sulleiro-Avendaño E2, de Miguel-Marañón M2, Padilla-Gallego ME2, Sancho-López A3, Ruiz-Antúnez S4, Prieto-Yerro C4.
- Revista clinica espanola.Rev Clin Esp.2015 May;215(4):230-235. doi: 10.1016/j.rce.2014.12.014. Epub 2015 Feb 8.
- The centralized procedure for registering medicinal products involves a joint assessment by all regulatory agencies of European Union member states, which are coordinated by the European Medicines Agency. Since its implementation in 1995, the Spanish Agency for Medicines and Healthcare Products (AEM
- PMID 25669719
Japanese Journal
- Identification of Phosphorylation Sites in the C-Terminal Region of Charged Multivesicular Body Protein 1A (CHMP1A)
- Bioscience, biotechnology, and biochemistry 77(6), 1317-1319, 2013-06-23
- NAID 10031184703
- Mammalian ESCRT-Ⅲ-Related Protein IST1 Has a Distinctive Met-Pro Repeat Sequence That Is Essential for Interaction with ALG-2 in the Presence of Ca²⁺
- Bioscience, biotechnology, and biochemistry 77(5), 1049-1054, 2013-05-23
- NAID 10031177595
- 最近のFDA、EMA/CHMPによる許認可にみられるギャップ
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- 英
- Committee for Medicinal Products for Human Use, CHMP
- 同
- 医薬品委員会
- 関
- 欧州医薬品庁 EMA
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