Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Commentary
  • Published:

Overhauling oversight—European drug legislation

At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. The European Parliament and the Council of the European Union. Off. J. Eur. Union. L136/2, 34–57 (2004).

  2. The European Parliament and the Council of the European Union. Off. J. Eur. Union. L136/2, 1–33 (2004)

  3. The Commission of the European Communities. Off. J. Eur. Union. L15, 17–38 (1987).

  4. The Commission of the European Communities. Off. J. Eur. Union. L159, 46–94 (2003).

  5. Taste, J.-B. Nat. Biotechnol. 22, 1490 (2004).

    Article  Google Scholar 

  6. European Commission. Provisions for Micro, Small and Medium-Sized Enterprises (SMEs), Establishing the Circumstances in Which SMEs May Pay Reduced Fees, Defer Payment of the Fee, or Receive Administrative Assistance. (EC, Brussels, Belgium, October 2004). http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/SMEs%20provisions-Consultation%20paper-10142004.pdf

  7. European Medicines Agency. EMEA Public Statement on Fee Reductions for Designated Orphan Medicinal Products of 7 January 2005 (EMEA-H-4042-01.Rev.5) (EMEA, London, UK, January 7, 2005). http://www.emea.eu.int/pdfs/human/comp/404201en.pdf

  8. The European Agency for the Evaluation of Medicinal Products. PIM System Specifications. Ref: EMEA/19503/04/v1/6/en/Final (EMEA, London, 2004) http://pim.emea.eu.int/doc/PIM%20Specifications%20-%20Business%20Case%20v1-6-en.pdf

  9. European Commission. Draft Commission Regulation on the Conditional Marketing Authorisation for Medicinal Products Falling Within the Scope of Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004. (EC, Brussels, Belgium, November 9, 2004). http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2004/nov/draft-regulation_13-10-2005.pdf

  10. European Medicines Agency. Accelerated Evaluation of Products Indicated for Serious Diseases (Life-Threatening or Heavily Disabling Diseases) (CPMP/495/96 rev.1) (EMEA, London, UK, September 18, 2001). http://www.emea.eu.int/pdfs/human/regaffair/049596en.pdf

  11. Sheridan, C. Nat. Biotechnol. 23, 397–398 (2005).

    Article  CAS  Google Scholar 

  12. European Commission. The Rules Governing Medicinal Products in the European Union: Pharmacovigilance for Medicinal Products for Human and Veterinary Use, vol. 9 (EC, Brussels, 2004).

Download references

Acknowledgements

I would like to thank Donald Beers for help in the preparation of this article.

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Tsang, L. Overhauling oversight—European drug legislation. Nat Biotechnol 23, 1050–1053 (2005). https://doi.org/10.1038/nbt0905-1050

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt0905-1050

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing