Sage Journals: Discover world-class research

Abstract

Pharmaceutical companies, regulatory agencies, and contract service organizations are managing substantial and ongoing changes to pharmacovigilance legislation in the European Economic Area, and penalties for noncompliance are potentially large. Given that the majority of pharmaceutical companies and contract service organizations have global reach, the impact of this change is being felt far beyond the boundaries of the European Economic Area.

Keywords

pharmacovigilance Europe legislation Good Pharmacovigilance Practice

Get full access to this article

View all access options for this article.

References

Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Official Journal of the European Union. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF. Published December 15, 2010.

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. Official Journal of the European Union. http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf. Published December 15, 2010.

Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. Official Journal of the European Union. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF. Published June 19, 2012.

European Medicines Agency. Good pharmacovigilance practices. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=WC0b01ac058058f32c. Accessed July 31, 2013.

European Commission. The rules governing medicinal products in the European Union—guidelines on pharmacovigilance for medicinal products for human use. Volume 9. http://ec.europa.eu/health/documents/eudralex/vol-9/. Published September 2008.

European Commission. The rules governing medicinal products in the European Union—guidelines on pharmacovigilance for medicinal products for human use. Volume 9A. http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf. Published September 2008.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline E2C (R2): Periodic Benefit-Risk Evaluation Report (PBRER). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_Step4.pdf. Published December 17, 2012.

Food and Drug Administration. Providing postmarket periodic safety reports in the ICH E2C(R2) format (Periodic Benefit-Risk Evaluation Report). FDA draft guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf. Published April 2013.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). ICH Harmonised Tripartite Guideline E2C (R1): Periodic Safety Update Report (PSUR). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/Step4/E2C_R1__Guideline.pdf. Updated November 2005.

10.

Health Canada. Notice—Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report—ICH Topic E2C(R2), as of March 1, 2013. File number 13-105055-393. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e2cr2_notice_avis-eng.php. Published April 9, 2013.

11.

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. Official Journal of the European Communities. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32001L0020:en:NOT. Published April 4, 2001.