European Union centralised procedure for marketing authorisation of oncology drugs: An in-depth review of its efficiency

European Journal of Cancer

Volumn 42, Issue 4, 2006, Pages 446-455

  Netzer, Tilo ^a  

^a MERCK KGAA   (Germany)

Author keywords

Centralised Procedure; European Medicines Agency; Marketing authorisation procedure; Oncology drugs; Orphan drugs

Indexed keywords

ALEMTUZUMAB; ANTINEOPLASTIC AGENT; ARSENIC TRIOXIDE; BEXAROTENE; BORTEZOMIB; CAPECITABINE; CETUXIMAB; DOCETAXEL; DOXORUBICIN; FULVESTRANT; IBRITUMOMAB TIUXETAN; IMATINIB; PACLITAXEL; RITUXIMAB; TASONERMIN; TEMOPORFIN; TEMOZOLOMIDE; TOPOTECAN; TOREMIFENE; TRASTUZUMAB; UNCLASSIFIED DRUG;

BREAST CANCER; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; COLORECTAL CANCER; CUTANEOUS T CELL LYMPHOMA; DRUG EFFICACY; DRUG INDICATION; DRUG LEGISLATION; DRUG MARKETING; DRUG PACKAGING; DRUG SAFETY; EUROPEAN UNION; FOLLICULAR LYMPHOMA; GLIOBLASTOMA; HUMAN; KAPOSI SARCOMA; MULTIPLE MYELOMA; ONCOLOGY; OVARY CARCINOMA; PRIORITY JOURNAL; PROMYELOCYTIC LEUKEMIA; REVIEW; STATISTICAL SIGNIFICANCE;

EID: 32444431722     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2005.04.045     Document Type: Article

References (14)

1. F. Pignatti, B. Aronsson, and S. Vamvakas Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology Crit Rev Onc Hematol 42 2002 123 135
2. Regulation (EC) 726/2004 of 30th April 2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official J Eur Union 2004;L136:1-33.
3. Regulation (EC) 141/2000 of 22nd January 2000 on orphan medicinal products. Official J Eur Union 2000;L18:1-5.
4. Commission Directive 2003/63/EC of 25th June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official J Eur Union 2003;L159:46-94.
5. European Agency for the Evaluation of Medicinal Products. Note for guidance on evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 rev. 2). European Agency for the Evaluation of Medicinal Products London, 2002.
6. European Agency for the Evaluation of Medicinal Products. Accelerated evaluation of products indicated for serious diseases (life-threatening or heavily disabling diseases) (CPMP/495/96 rev. 1). European Agency for the Evaluation of Medicinal Products London, 2001.
7. European Medicines Agency. Available from http://www.emea.eu.int/home. htm.
8. European Commission, Enterprise Directorate-General. The notice to applicants, vol. 2A, Procedures for Marketing Authorisation. European Commission. Brussels 2002.
9. E.M. Healy, and K.I. Kaitin The European Agency for the Evaluation of Medicinal Products' Centralised Procedure for product approval: current status Drug Inf J 33 1999 969 978
10. K. Redmond The US and European regulatory systems: a comparison J Ambul Care Manage 27 2 2004 105 114
11. M. Ericson, C. Webster, and F. de Cremier Accelerated assessment and temporary marketing authorisation in the European Union Regulatory Affairs Journal 15 9 2004 645 649
12. European Commission, Enterprise Directorate-General. Available from http://dg3.eudra.org/F2/register/orphreg.htm.
13. F. Pignatti, H. Boone, and I. Moulon Overview of the European regulatory approval system J Ambul Care Manage 27 2 2004 89 97
14. European Medicines Agency. Available from http://esubmission.eudra.org/ pim.html.