Dialogue between companies and the EMEA regarding the centralized procedure from an industry's point of view

Drug Information Journal

Volumn 40, Issue 1, 2006, Pages 15-21

  Heidenreich, Karin ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Centralized Procedure; Oral Explanation Meeting; Product Information Linguistic Review Process; Scientific Advice Procedure

Indexed keywords

DRUG;

CENTRALIZATION; CONSENSUS DEVELOPMENT; COOPERATION; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG INDUSTRY; DRUG INFORMATION; DRUG QUALITY; DRUG SAFETY; EUROPEAN UNION; EXPERIENCE; GOAL ATTAINMENT; HUMAN; INTERPERSONAL COMMUNICATION; LANGUAGE; LINGUISTICS; MEDICINE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY CONTROL; REGISTRATION; REVIEW;

EID: 33244472381     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150604000103     Document Type: Review

References (12)

1. Mandate, Objectives and Rules of Procedure of the Scientific Advice Working Party, EMEA/CHMP/SAWP/69686/04 Rev. 2, May 2005. Available at: http://www.emea.eu.int/pdfs/human/sciadvice/6968604en.pdf.
2. New Framework for Scientific Advice and Protocol Assistance, EMEA/267187/2005, draft of September 2005, http://www.emea.eu.int/pdfs/human/ sciadvice/26718705 en.pdf.
3. Dates of Forthcoming SAWP Meetings and Deadlines for Scientific Advice or Protocol Assistance Request Submissions, Year 2004/2005, EMEA/H/20338/04. Available at: http://www.emea.eu.int/pdfs/human/sciadvice/2033804en.pdf.
4. EMEA Guidance for Companies Requesting Scientific Advice (SA) and Protocol Assistance (PA), EMEA/H/4260/01 Rev. 2, June 2003. Available at: http://www.emea.eu.int/pdfs/human/sciadvice/426001en.pdf.
5. Fees Payable to the EMEA-February 2005 Update (EMEA/H/5913/03). Available at: http//www .emea.eu.int/htms/human/presub/591303e.pdf.
6. Standard Operating Procedure on Validation of Scientific Advice/Protocol Assistance Request, EMEA/SOP/H/3039 Rev. 1, 15 June 2002. Available at: http://www.emea.eu.int/htms/general/sop/sop.htm.
7. Notice to Applicants, Volume 2A, Procedures for Marketing Authorization, Chapter 4, Centralised Procedure, Rev. 1, December 2002. Available at: http://pharmacos.eudra.org/F2/eudralex/vol-2/A/Chap4rev1_122002%20.pdf.
8. CPMP Guidance on the Rapporteurs Meetings With Applicants on the CPMP List of Questions, CPMP/2270/02,21 November 2002. Available at: http://www.emea.eu.int/pdfs/human/regaffair/227002en.pdf.
9. CPMP Guidance to Applicants on CPMP Oral Explanations in Relation to Centralized Applications, CPMP/2390/01 Rev. 1,14 February 2002. Available at: http://www.emea.eu.int/pdfs/human/regaffair/239001en.pdf.
10. The New Product Information Linguistic Review Process for New Application in the Centralized Procedure, EMEA/5542/02/Rev. 3, October 2005. Available at: http://www.emea.eu.int/pdfs/human/regaffair/554202 en.pdf.
11. The European Agency for the Evaluation of Medicinal Products, Tenth Annual Report 2004, EMEA/61492/2005/EN/Final. Available at: http://www.emea.eu. int/pdfs/general/direct/emeaar/ar6149205en.pdf.
12. General Principles: EMEA-FDA Parallel Scientific Advice Meetings, Pilot Program, September 17, 2004. Available at: www.emea.eu.int/pdfs/general/direct/ internationalcoop/EMEA-FDAScientific Advice.pdf or www.fda.gov/oia/ pilotprogram0904.html.