Future of the European Union regulatory network in the context of the uptake of new medicines

British Journal of Clinical Pharmacology

Volumn 76, Issue 1, 2013, Pages 1-6

  Hoebert, Joëlle M ^a   Irs, Alar ^b,c   Mantel Teeuwisse, Aukje K ^a   Leufkens, Hubert G M ^a,d  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UNIVERSITY OF TARTU   (Estonia)

^c State Agency of Medicines   (Estonia)

^d MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ANAGRELIDE; ARIPIPRAZOLE; ATAZANAVIR; BORTEZOMIB; CETUXIMAB; CHOLERA VACCINE; CINACALCET; CLADRIBINE; DARIFENACIN; DULOXETINE; FIBRINOGEN PLUS THROMBIN; FOSAMPRENAVIR; FULVESTRANT; HIRULOG; IBANDRONIC ACID; IBRITUMOMAB TIUXETAN; INSULIN DETEMIR; INSULIN GLULISINE; MITOTANE; OXYBUTYNIN; PEMETREXED; PREGABALIN; RECOMBINANT BLOOD CLOTTING FACTOR 8; STRONTIUM RANELATE;

ACUTE CORONARY SYNDROME; ADRENAL CORTEX CARCINOMA; ANXIETY DISORDER; ARTICLE; BIPOLAR DISORDER; BREAST CANCER; COLORECTAL CANCER; DEPRESSION; DIABETES MELLITUS; DIABETIC NEUROPATHY; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG INDUSTRY; EPILEPSY; EUROPEAN UNION; FOLLICULAR LYMPHOMA; HAIRY CELL LEUKEMIA; HEAD AND NECK CANCER; HEALTH CARE ACCESS; HEALTH CARE AVAILABILITY; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HEMOPHILIA A; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERPARATHYROIDISM; INTERNATIONAL COOPERATION; LUNG NON SMALL CELL CANCER; MULTIPLE MYELOMA; NEURALGIA; PARATHYROID CARCINOMA; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; RESOURCE ALLOCATION; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; THROMBOTIC THROMBOCYTOPENIC PURPURA; URGE INCONTINENCE; URINE INCONTINENCE;

DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; EUROPEAN UNION; EVIDENCE-BASED MEDICINE; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS;

EID: 84879474356     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04476.x     Document Type: Article

References (16)

1. Healy EM, Kaitin KI. The European Agency for the evaluation of medicinal products' centralized procedure for product approval: current status. Drug Inf J 1999; 33: 969-978.
2. European Medicines Agency. What we do. 1995-2010. 2012. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000091.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028a42 (last accessed 30 October 2012).
3. European Medicines Agency. The European Medicines Agency Road Map to 2015. London: The Agency's Contribution to Science, Medicines, Health, 2010.
4. Heads of Medicines Agencies. A strategy for the heads of medicines agencies, 2011-15; 2010.
5. Heads of Medicines Agencies. Contact points for HMA and HMA-WGs: list of contacts. 2008. Available at http://www.hma.eu/fileadmin/dateien/HMA_joint/Contact_HMA_and_HMA_WGs.pdf (last accessed 24 March 2011).
6. European Medicines Agency. CHMP: overview. 1995-2010. 2012. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000095.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028c7a (last accessed 30 October 2012).
7. Nolte E, Newbould J, Conklin A. International variation in the usage of medicines. A review of the literature. RAND Corporation 2010.
8. Richards M. Extent and causes of international variations in drug usage. Secretary State of Health; 2010.
9. Buysse IM. Impact of the Economic Recession on the Pharmaceutical Sector. Utrecht: Utrecht University, WHO CC for Pharmacoepidemiology & Pharmaceutical Policy Analysis, 2010.
10. United Nations, Department of Economic and Social Affairs. World population prospects: the 2008 revision population database. 11 Mar 2009. Available at http://esa.un.org/unpd/wpp/unpp/panel_population.htm (last accessed 19 November 2010).
11. Cohen J, Faden L, Predaris S, Young B. Patient access to pharmaceuticals: an international comparison. Eur J Health Econ 2007; 8: 253-266.
12. McCabe C, Bergmann L, Bosanquet N, Ellis M, Enzmann H, von Euler M, Jönsson B, Kallen KJ, Newling D, Nüssler V, Paschen B, de Wilde R, Wilking N, Teale C, Zwierzina H. Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective. Ann Oncol 2009; 20: 403-412.
13. Miltenburger C, Günther OH, Justo N, Karampampa K, Texier-Richard B, Schweikert B. A Survey of Barriers to Treatment Access in Rheumatoid Arthritis in France, Germany, Italy, Spain and the UK. October 2009. Available at http://www.comparatorreports.se/RA%20Barrier%20Report_FINAL_050110.pdf (last accessed 20 September 2010).
14. European Medicines Agency. CHMP rules of procedure. 2007. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004628.pdf (last accessed 24 March 2011).
15. European Medicines Agency. Strategy for regulatory and scientific training within the EU regulatory network. 2012. Available at http://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/Office_Training/2011_05_OTSG_Strategy.pdf (last accessed 14 August 2012).
16. European Commission. Evaluation of the European Medicines Agency. Final Report. 2012. Available at http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf (last accessed 14 August 2012)