Towards a harmonized radiopharmaceutical regulatory framework in Europe?

Quarterly Journal of Nuclear Medicine and Molecular Imaging

Volumn 53, Issue 4, 2009, Pages 394-401

  Decristoforo, C ^a,b   Penuelas I ^b,c  

^a INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^b European Association of Nuclear Medicine   (Austria)

^c Instituto de Investigación Sanitaria de Navarra   (Spain)

Author keywords

Legislation, medical; Radiopharmaceuticals; Research

Indexed keywords

FLUORODEOXYGLUCOSE F 18; RADIOPHARMACEUTICAL AGENT;

CLINICAL PRACTICE; CONFERENCE PAPER; DRUG INDUSTRY; EUROPE; GOOD MANUFACTURING PRACTICE; LAW; MARKETING; MEDICAL LITERATURE; MEDICAL RESEARCH; NUCLEAR MEDICINE; PHARMACY; QUALITY CONTROL;

DRUG APPROVAL; EUROPE; GOVERNMENT REGULATION; ISOTOPE LABELING; NUCLEAR MEDICINE; RADIOPHARMACEUTICALS;

EID: 74949091202     PISSN: 18244785     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (22)

1. Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Internet] Consolided version updated at 30/12/2008 Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir-2001-83-cons/ dir2001-83-cons-20081230-en.pdf [cited 2009, May 12].
2. Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel (AmRadV). BGBl. I S. 48 [Internet]. Available from: http://bundesrecht.juris.de/amradv/index.html, accessed 30 January 2009 [cited 2009, Jan 30th].
3. Decreto legislativo 6 novembre 2007, N 200, Supplemente ordinario alla Gazetta Ufficiale, Seria Generale.26:72, 2007 [Internet] Available from: http://www.parlamento.it/leggi/deleghe/07200dl.htm [cited 2009, Feb 5].
4. Guidance Note 14, The supply of unlicensed relevant medicinal products for individual patients', Medicines and Healthcare products Regulatory Agency 2008. [Internet] Available From: http://www.mhra.gov.uk/home/groups/comms-ic/ documents/publication/con007547.pdf [cited 2009;May 16].
5. Befleri Tibbi Ürünler Ruhsatlandirma Yönetmeli inde De ifliklik Yapilmasina Dair Yönetmelik. [Internet] Available from: http://rega.basbakanlik.gov.tr/eskiler/2009/04/20090422-11.htm [cited 2009, May 16].
6. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-1l/dir-2003-94/dir-2003-94-en.pdf [cited May 12th 2009].
7. EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use, Part I, Chapter 1 Quality Management [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/ pdfs-en/2005-10-gmp-part1-chap1.pdf [cited 2009, May 12].
8. EudraLex. The Rules Governing Medicinal Products in the European Union [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/eudralex-en.htm [cited 2009, May 12].
9. GMP-Annex 3. [Internet] Available from: http://ec.europa.eu/enterprise/ pharmaceuticals/eudralex/vol-4/2008-09-annex3.pdf [cited 2009, May 12].
10. Regulation EC No 1394/2007 of 13 November 2007 [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg-2007-1394/ reg-2007-1394 en.pdf [cited 2009, May 12].
11. Guidelines on current good Radiopharmacy Practice (cGRPP) in the Preparation of Radiopharmaceuticals [Internet] Available from: http://www.eanm.org/scientific-info/guidelines/gl-radioph-cgrpp.pdf [cited 2009, May 12].
12. PIC/S Guide to good practices for preparation of medicinal products in healthcare establishments. Pharmceutical Inspetion Convention Co-Operation Scheme, PE 010-1. [Internet] Available from: http://www.picscheme.org/publis/ guides/PE-010-3%20-Revised-GPP-Guide.pdf [cited 2009, May 12].
13. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-1/dir-2001-20/dir-2001-20-en.pdf [cited 2009, May 12].
14. Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials CHMP/QWP/185401/2004[Internet] Available from: http://www.emea.europa.eu/pdfs/ human/qwp/18540104en. pdf. [cited 2009, May 12].
15. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol-1l/dir-2003-94/dir-2003-94-en.pdf [cited 2009, Feb 5].
16. 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. [Internet] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir-2005-28/dir- 2005-28-en.pdf [cited 2009, May 12].
17. Guideline on strategies to identify and mitigate risks for first-inhuman clinical trials with Investigational Medicinal Products. CHMP/SWP/28367/ 07[Internet] Available from: http://www.emea.europa.eu/pdfs/human/swp/2836707en. pdf [cited 2009, May 16].
18. Harding K, Mather SJ. Investigative clinical studies with radiopharmaceuticals. Nucl Med Commun 2007;28:1-2.
19. Final Position Paper on non-clinical safety studies to support clinical trials with a single microdose EMEA/CPMP/SWP/2599/02/Rev1. [Internet] Available from: http://www.emea.europa.eu/pdfs/human/swp/2836707enfin.pdf. [cited 2009, May 12].
20. Verbruggen A, Coenen HH, Deverre JR, Guilloteau D, Langstrom B, Salvadori PA et al. Guideline to regulations for RP in early phase clinical trials in the EU. Eur J Nucl Med Mol Imaging 2008;35:2144-51.
21. Pharm Eur, European Pharmacopoeia, 6th edition. European Directorate for the Quality of Medicines (EDQM), Strasbourg; 2008.
22. European Association of Radiopharmacy, Radiopharmacy Committee site, Education. [Internet] Available from: https://www.eanm.org/committees/ radiopharmacy/rapha-education.php?navId=135 [cited 2009, May 16].