The EU is ready for non-biological complex medicinal products

GaBI Journal

Volumn 5, Issue 1, 2016, Pages 30-35

  Ehmann, Falk ^a   Pita, Ruben ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

Complex pharmaceutical forms; EMA; Nanomedicines; Regulatory science

Indexed keywords

CHEMICAL COMPOUND; NONBIOLOGICAL COMPLEX DRUG; UNCLASSIFIED DRUG;

ARTICLE; AUTHORITY; DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; EUROPE; EUROPEAN UNION; NANOIMAGING; NANOMEDICINE; NANOTECHNOLOGY; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; PRODUCT DEVELOPMENT; PRODUCT SAFETY; PUBLICATION;

EID: 85008253471     PISSN: 20336403     EISSN: 20336772     Source Type: Journal    
DOI: 10.5639/gabij.2016.0501.008     Document Type: Article

References (19)

1. Schellekens H, Stegemann S, Weinstein V, de Vlieger JS, Flühmann B, Mühlebach S, et al. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. AAPS J. 2014;16(1):15-21.
2. Flühmann B, Crommelin DJA, de Vlieger JSB, Borchard G, Scott E McNeil, Mühlebach S, et al. Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):167-70. doi:10.5639/gabij.2015.0404.037
3. European Commission. EU Pharmaceutical Informations. EudralLex Volume 1-Pharmaceutical legislation medicinal products for human use [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm
4. Heads of Medicines Agencies. CMDH What's new [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.hma.eu/cmdh.html
5. European Medicines Agency. Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal. EMA/CHMP/806058/2009/Rev. 02. 21 February 2013 [homepage of Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140351.pdf
6. European Medicines Agency. Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1/Corr**. 20 January 2010 [homepage of Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500070039
7. Borchard G, Flühmann B, Mühlebach S. Nanoparticle iron medicinal products-requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies. Regul Toxicol Pharmacol. 2012;64(2):324-8.
8. Ehmann F, Sakai-Kato K, Duncan R, Pérez de la Ossa DH, Pita R, et al. Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines. Nanomedicine (Lond). 2013;8(5):849-56.
9. European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04 Rev 1. 23 October 2014 [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf
10. European Commission. Technical paper for regulatory cooperation on generic medicines. Proposal of the European Union. 26 January 2016 [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://trade.ec.europa.eu/doclib/docs/2016/january/tradoc_154172.pdf
11. International Pharmaceutical Regulators Forum. IPRF Nanomedicines Working Group [homepage on the Internet]. [cited 2016 Apr 1]. Available from: https://www.i-p-r-f.org/en/working-groups/nanomedicines-working-group/
12. International Pharmaceutical Regulators Forum. IPRF Nanomedicines Working group-Information sharing and mapping (as of January 2016) [homepage on the Internet]. [cited 2016 Apr 1]. Available from: https://www.i-p-r-f.org/files/7414/5387/7778/IPRF_Nanomedicines_WG_-_info_mapping_Jan2016.pdf
13. European Medicines Agency. Scientific guidelines [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb
14. European Medicines Agency. Scientific advice and protocol assistance [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9
15. European Medicines Agency. Innovation Task Force [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000334.jsp&mid=WC0b01ac05800ba1d9
16. Adapted from Crommelin, Daan JA, and Jon SB de Vlieger, eds. Non-Biological Complex Drugs: The Science and the Regulatory Landscape. Vol. 20. Springer, 2015.
17. Flynn Pharma Ltd. Depodur marketing ceased [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.flynnpharma.com/about-us/news/depodur-marketing-ceased
18. European Medicines Agency. European public assessment reports [homepage on the Internet]. [cited 2016 Apr 1]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124
19. Noorlander CW, Kooi MW, Oomen AG, Park MV, Vandebriel RJ, Geertsma RE. Horizon scan of nanomedicinal products. Nanomedicine (Lond). 2015;10(10):1599-1608.