Regulation of nanomedicines in the EU: Distilling lessons from the pediatric and the advanced therapy medicinal products approaches

Nanomedicine

Volumn 5, Issue 1, 2010, Pages 135-142

  Chowdhury, Nupur ^a  

^a UNIVERSITY OF TWENTE   (Netherlands)

Author keywords

Advanced therapy medicinal products; Efficacy; Internal market; Market authorization; Nanomedicine; Pediatrics; Safety regulation

Indexed keywords

DOXORUBICIN;

ARTICLE; CHILD HEALTH CARE; DRUG EFFICACY; DRUG FORMULATION; DRUG MARKETING; DRUG QUALITY; DRUG RELEASE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPE; HEALTH CARE POLICY; HUMAN; INFORMATION DISSEMINATION; NANOENCAPSULATION; NANOMEDICINE; NANOTECHNOLOGY; ORGANIZATIONAL STRUCTURE; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL DELEGATION; PUBLIC HEALTH; QUALITY CONTROL;

EUROPEAN UNION; HUMANS; NANOMEDICINE; SOCIAL CONTROL, FORMAL;

EID: 75949112609     PISSN: 17435889     EISSN: None     Source Type: Journal    
DOI: 10.2217/nnm.09.91     Document Type: Article

References (29)

1. Wagner V, Dullart A, Bock A-K, Zweck A: The emerging nanomedicine landscape. Nat. Biotechnol. 24(10), 1211-1217 (2006). ** Good overview of the market size and variety of nanomedicines that have been launched in Europe and the USA, gathered from patent filings data.
2. Moghimi SM, Hunter AC, Murray JC: Nanomedicine: current status and future prospects. FASEB J. 19, 311-330 (2005).
3. Sadrieh N: FDA considerations for regulation of nanomaterial containing products. Conference presentation: Nanotechnology: Impact on Health and Regulation. Organized by the Medicines and Health Products Regulatory Agency, UK (2005).
4. Warren, CW Chan: Research Highlights. Nanomedicine 4(5), 507-508 (2009).
5. Jefferys B: The regulation of medical devices and the role of the Medical Devices Agency. Br. J. Clin. Pharmacol. 52, 229-235 (2001). * Good comparative study on the differences between the regulation and institutional framework in the medicinal devices and the medicinal products sector in the UK.
6. Paradise JK, Diliberto G, Tisdale A, Kokkoli E: Exploring emerging nanobiotechnology drugs and medical devices. Food Drug Law J. 63(2), 415 (2008).
7. Wagner V, Dullart A, Bock A-K, Zweck A: The emerging nanomedicine landscape. Nat.Biotechnol. 24(10), 1214 (2006).
8. Rapoport N, Gao Z, Kennedy A: Multifunctional nanoparticles for combining ultrasonic tumor imaging and targeted chemotherapy. J. Natl Cancer Institute 99(14), 1095-1106 (2007).
9. Bhogal N: Regulatory and scientific barriers to the safety evaluation of medical nanotechnologies. Nanomedicine 4(5), 495-498 (2009). ** Good overview of the regulatory developments in Europe and the USA and the scientific barriers in the evaluation of medical nanotechnologies.
10. Abraham J, Lewis G: Regulating Medicines in Europe: Competition, Expertise and Public Health. Routledge, London, UK, 207-212 (2000).
11. Bellucci S, Chiaretti M, Cucina A, Carru GA, Chiaretti AI: Multiwalled carbon nanotube buckypaper: toxicology and biological effects in vitro and in vivo. Nanomedicine 4(5), 531-540 (2009).
12. Roszek B, de Jong W, Geertsma R: Nanotechnology in medical applications: state-of-the-art in materials and devices. RIVM report. 265001001. www.nano.org.uk/nanomednet/images/ stories/Reports/nanotechnology%20 and%20medical%20applications-netherlands.pdf (Accessed 9 August 2009) ** Exhaustive study of the range of applications of nanomaterials in medical technology.
13. EMEA, 2006. Reflection Paper on Nanotechnology-Based Medicinal Products for Human Use, EMEA/CHMP/79769/2006. www.emea.europa.eu/pdfs/human/ genetherapy/7976906en.pdf (Accessed 2 August 2009)
14. Market survey report on Medical Nanotechnology Markets: Trends, Industry Participants, Product Overview and Market Drivers, pegs the number of authorizations at 18 (Trimark Publications, 2008). www.trimarkpublications.com/ samples/ mednanosample.pdf (Accessed 2 August 2009)
15. Darin Y Furgeson: Nanotools for toxicity assessments of nanomedicines; to the FDA, puts the number as 12 (2008). www.fda.gov/ohrms/DOCKETS/ac/08/ slides/2008-4370s1-05-Guest-Furgeson.pdf (Accessed 9 August 2009)
16. Duncan R: Polymer Therapeutics as Nanomedicines. Presentation at the EMEA First Ad Hoc Expert Group on Nanomedicines, London, UK (2009). www.emea.europa.eu/pdfs/conferenceflyers/ nanotech-workshop/ruth-duncan.pdf (Accessed 2 August 2009)
17. Lebourgeois C: Device and Drug Combination Products: a New Regulatory, Reimbursement and Marketing Challenge. Lifescience Online (2008). www.lifescience-online.com/articles.html?por talPage=Lifescience+Today. Articles&a=1014 (Accessed 17 August 2009)
18. OJ L 169, 12.7.1993. Council Directive concerning medical devices. http://eur-lex.europa.eu/LexUriServ/site/en/ consleg/1993/L/01993L0042-20031120- en. pdf (Accessed 2 August 2009)
19. O J L 189. 20.7.1990. Council Directive on the approximation of the laws of the Member States relating to active implantable medical devices. http://eur-lex.europa.eu/LexUriServ/ LexUriServ. do?uri=CELEX:31990L0385:en:HTML (Accessed 2 August 2009)
20. The framework has been understood as 'additional' in the sense of it being an add to the existing legal framework of Directive 2001/83/EC and Regulation EC/726/2004. See Recital 6 of Regulation EC/1394/2007. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg-2007-1394/ reg-2007-1394-en.pdf (Accessed 9 August 2009)
21. OJ L 136/34, 31.3.2004. Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2004:136:0034: 57:EN:PDF (Accessed 9 August 2009)
22. OJ L 136/1, 30.4.2004, p.1 Regulation of European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, amended by Regulation EC/1901/2006. http://ec.europa.eu/ enterprise/ pharmaceuticals/eudralex/vol-1/reg2004726/reg2004726en.pdf (Accessed 2 August 2009)
23. Rationale for centralized authorization procedure, Recital 9 of Regulation EC/1394/2007 on advanced therapy medicinal products. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg2007-1394/ reg-2007-1394-en.pdf (Accessed 2 August 2009)
24. Jong WH, Roszek B, Geertsma R: Nanotechnology in medical applications: possible risks for human health. RIVM report. 265001002/2005, 34. www.rivm.nl/bibliotheek/ rapporten/265001002.pdf (Accessed 2 August 2009).
25. OJ L 378/1, 27.12.2006. Regulation EC/1901/2006 on medicinal products for paediatric use. http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-1/ reg-2006-1901/reg-2006-1901-en.pdf (Accessed 9 August 2009)
26. OJ L 324/121, 10.12.2007. Regulation EC/1394/2007 on advanced therapy medicinal products. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol- 1/reg-2007-1394/reg-2007-1394-en.pdf
27. European Medicines Agency: Medicines and Emerging Science. www.emea.europa.eu/htms/human/mes/ emergingtechnologies.htm#Nanotechnology (Accessed 2 August 2009)
28. Papaluca-Amati M: Nanotechnology: "Safety for Success" Guidance in the Medical Area, Presentation made at the 2nd Annual Nanotechnology Workshop, Brussels (2008). www.mmmc.be/sanco/nano/ Presentations2008/ M%20Papaluca-AMAti%20Nanomedicines%20Oct%20 2008%20Brussels%20-MPA.pdf (Accessed on 2 August 2009) ** Good overview of the ongoing activity in the EMEA on nanomedicines.
29. D'Silva J, Van Calster G: Taking temperature - a review of European Union regulation in nanomedicine (2008). http://ssrn.com/abstract=1285099 (Accessed 2 August 2009)