Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development - A comparison of regulations and initiatives on both sides of the Atlantic reveals differences that inter

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Navigating Differences Between FDA and EMEA for Regulatory Compliance During Drug Development
A comparison of regulations and initiatives on both sides of the Atlantic reveals differences that international companies need to understand.


BioPharm International


References

1. European Commission Directive 2001/20/EC. Clinical trial directive. 2004 May. Brussels, Belgium. Available from: http://www.ec.europa.eu/enterprise/pharmaceuticals/pharmacos/dir200120ec.htm.

2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. E6: Good Clinical Practice. Geneva, Switzerland. Available from: http://www.ich.org/.

3. European Commission. Directive 2003/94/EC, Laying down the Principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational products for human use. Brussels, Belgium. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev1.htm

4. European Commission. EUDRALEX, Vol. 4, Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice. Annex 13, Revision 1. Brussels. 2003 July. Manufacture of investigational medicinal products, Available from: pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/anx13en030303Rev1.pdf

5. US Food and Drug Administation, Rockville, MD. Pharmaceutical cGMPs for the 21st century—A risk-based approach. Press Release, Aug. 21, 2002, Available from: http://www.fda.gov/oc/guidance/gmp.html and Final report, Fall 2004. Available from: http://www.fda.gov/Cder/gmp/gmp2004/GMP_finalreport2004.htm and

6. FDA. Guidance for industry. Q8. Pharmaceutical development, Available from: http://www.fda.gov/cder/guidance/6746fnl.pdf.

7. FDA. Guidance for industry. PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance. Available from: http://www.fda.gov/cder/guidance/6419fnl.htm.

8. FDA. Guidance for industry. INDs—Approaches to complying with CGMP during Phase 1. Available from: http://www.fda.gov/cder/guidance/6164dft.htm.

9. FDA. ONDC's new risk-based pharmaceutical quality assessment system. 2004 September 29. Available from: http://www.fda.gov/cder/gmp/gmp2004/ondc_reorg.htm.

10. European Commission. Enterprise and Industry. Rules governing medicinal products in the European Union, Volume 4, Good manufacturing practices for medicinal products for human and veterinary use. Available from: http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm.

11. FDA. CDER. Guideline on the preparation of investigational new drug products (human and animal). 1991 March. Available from: http://www.fda.gov/cder/guidance/old042fn.pdf.

12. European Commission. Volume 4. Good manufacturing practices. Annex 16. Certification by a qualified person and batch release. 2001 July. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

13. FDA. CDER. Content and format of investigational new drug applications (INDs) for Phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products, 1995 November. Available from: http://www.fda.gov/cder/guidance/clin2.pdf.

14. Medicines and Healthcare products Regulatory Agency. http://www.mhra.gov.uk.

15. French Health Products Safety Agency, http://www.afssaps.sante.fr

16. FDA. Guidance for industry Q9 quality risk management Available from: http://www.fda.gov/cder/guidance/7153fnl.htm

17. FDA. Guidance for industry. Quality systems approach to pharmaceutical current good manufacturing practice regulations. 2004 September. Available from: http://www.fda.gov/cder/Guidance/6452dft.htm

18. Federal Register September 19, 2005. Submission of chemistry, manufacturing, and controls information in a new drug application under the new pharmaceutical quality assessment system; Extension of application and comment deadlines. Available from: http://www.fda.gov/OHRMS/Dockets/98fr/05-18515.pdf.


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