Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Literatur
Alqahtani S, Seoane-Vazquez E, Rodriguez-Monguio R, Eguale T (2015) Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiol Drug Saf 24:709–715
Arlett P, Portier G, de Lisa R, Blake K, Wathion N, Dogne I-M, Spooner A, Rain J, Rasi G (2014) Proactively managing the risk of marketed drugs: experience with the EMA pharmacovigilance risk assessment committee. Nat Rev Drug Discovery 13:395–397
Arnadottir AH, Haajer-Ruskamp FM, Straus SMJ, Eichler HG, de Graeff PA, Mol PGM (2011) Additional safety risk to exceptionally approved drugs in Europe? Br J Clin Pharmacol 72:490–499
Avorn J, Kesselheim AS (2015) The 21st century cures act – Will it take us back in time? N Engl J Med 372:2473–2475
Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JC, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, Hirsch G (2014) Accelerated access to innovative medicines for patients in need. Clin Pharmacol Ther 96:559–571
Banzi R, Gerardi C, Bertele V, Garattini S (2015) Approvals of drugs with uncertain benefit-risk profiles in Europe. Eur J Intern Med 26:572–584
Banzi R, Gerardi C, Bertele’ V, Garattini S (2017) Conditional approval of medicines by the EMA. BMJ 357:j2062
BEUC (2019) BEUC response to the EMA Regulatory Science to 2025 strategic reflection. https://www.beuc.eu/publications/beuc-x-2019-040_prof_rasi_on_ema_regulatory_science_strategy.pdf
Boon WPC, Moors EHA, Meijer A, Schellekens H (2010) Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe. Clin Pharmacol Ther 88:848–853
Bundesinstitut für Arzneimittel und Medizinprodukte: Zulassungsverfahren. https://www.bfarm.de/DE/Arzneimittel/Arzneimittelzulassung/Zulassungsverfahren/_node.html
Carpenter D (2014) Can expedited FDA drug approval without expedited follow-up be trusted? JAMA Intern Med 174:95–97
Cohen D (2017) Cancer drugs: high price, uncertain value. BMJ 359:j4543
CPME (2019) CPME response to public consultation on EU Regulatory Science to 2025. http://doc.cpme.eu/adopted/2019/CPME_AD_Board_06042019_017_FINAL_EN_CPME.response.EMA.consultation.regulatory.science.to.2025.pdf
Darrow JJ, Avorn J, Kesselheim AS (2014) New FDA breakthrough-drug category – implications for patients. N Engl J Med 370:1252–1258
Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A (2017) Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009–13. BMJ 359:j4530
Deutscher Bundestag (2014): Verfahren zur Medikamentenzulassung und mögliche Auswirkungen eines Freihandelsabkommens mit den USA auf das deutsche Gesundheitswesen. Dokumentation WD 9 – 3000 – 037/14
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS (2012) Regulatory review of novel therapeutics – comparison of three regulatory agencies. N Engl J Med 366:2284–2293
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS (2014) Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA 311:368–377
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun J-D, Krumholz HM, Ross JS (2017a) Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA 317:1854–1863
Downing NS, Zhang AD, Ross JS (2017b) Regulatory review of new therapeutic agents – FDA versus EMA, 2011–2015. N Engl J Med 376:1386–1387
Duijnhoven RG, Straus SM, Raine JM, de Boer A, Hoes AW, De Bruin ML (2013) Number of patients studied prior to approval of new medicines: a database analysis. PLoS Med 10:e1001407
Dyer O (2016) FDA fails to monitor fast tracked drugs after approval, says US watchdog. BMJ 352:i371
Ebbers HC, Langedijk J, Bouvy JC, Hoekman J, Boon WP, de Jong JP, De Bruin ML (2015) An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe. Eur J Clin Pharmacol 71:1237–1244
Eichler HG, Aronsson B, Abadie E, Salmonson T (2010a) New drug approval success rate in Europe in 2009. Nat Rev Drug Discov 9:355–356
Eichler HG, Bloechl-Daum B, Abadie E, Barnett D, König F, Pearson S (2010b) Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov 10:277–291
Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G (2013) The risks of risk aversion in drug regulation. Nat Rev Drug Discov 12:907–916
Eichler HG, Bloechl-Daum B, Broich K, Kyrle PA, Oderkirk J, Rasi G, Santos Ivo R, Schuurman A, Senderovitz T, Slawomirski L, Wenzl M, Paris V (2018) Data rich, information poor: Can we use electronic health records to create a learning healthcare system for pharmaceuticals. Clin Pharmacol Ther 105:912–922
Eichler HG, Enzmann H, Rasi G (2019) Added therapeutic benefit and drug licensing. Nature Rev Drug Discov. https://doi.org/10.1038/d41573-019-00068-x
EMA, Committee for Medicinal Products for Human Use (CHMP) (2005) Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of regulation (ec) no 726/2004. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004883.pdf
EMA (2012) Annual Report 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2012/06/WC500128162.pdf
EMA (2013) Annual Report 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2013/04/WC500142077.pdf
EMA (2014) Annual Report 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2014/04/WC500165986.pdf
EMA (2015) Annual Report 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2015/04/WC500186306.pdf
EMA (2016a) Annual Report 2015. https://www.ema.europa.eu/en/documents/annual-report/2015-annual-report-european-medicines-agency_en.pdf
EMA (2016b) PRIME: priority medicines. http://www.ema.europa.eu/ema/index.jsp%3Fcurl%3Dpages/regulation/general/general_content_000660.jsp%26mid%3DWC0b01ac058096f643
EMA (2017a) Conditional marketing authorisation. Report on ten years of experience at the European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2017/01/WC500219991.pdf
EMA (2017b) Annual Report 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2017/05/WC500227334.pdf
EMA (2018a) Annual Report 2017. http://www.ema.europa.eu/docs/en_GB/document_library/Annual_report/2018/04/WC500248201.pdf
EMA (2018b) PRIME: a two-year overview. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500248828.pdf
EMA (2018c) First two CAR-T cell medicines recommended for approval in the European Union. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/06/WC500251219.pdf
EMA (2018d) EMA regulatory science to 2025 strategic reflection. http://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf
EMA (2019a) Annual Report 2018. https://www.ema.europa.eu/en/news/ema-annual-report-2018-published
EMA (2019b) From laboratory to patient: the journey of a centrally authorised medicine. https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf
EMA (2019c) EMA takes note of the European ombudsman’s decision on pre-submission activities. https://www.ema.europa.eu/en/news/ema-takes-note-european-ombudsmans-decision-pre-submission-activities
EPFIA (2019) EFPIA response to the EMA regulatory science strategy to 2025. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-response-to-the-ema-regulatory-science-strategy-to-2025/#
EPHA (2019) EPHA response to public consultation on EMA regulatory science to 2025. https://epha.org/wp-content/uploads/2019/07/contributionc45c6425-b37a-4053-8860-6b21b95930a8.pdf
Escher – The TI Pharma Platform for regulatory Innovation (2014) Improving the EU system for the marketing authorisation of medicines. Learning from regulatory practice. TI Pharma, Leiden
ESIP (2019) Response of ESIP on the public consultation on EMA regulatory science to 2025 – strategic reflection. https://epha.org/epha-response-to-public-consultation-on-ema-regulatory-science-to-2025/
European Ombudsman (2019) Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU. https://www.ombudsman.europa.eu/en/decision/en/116683
Farrell AT, Goldberg KB, Pazdur R (2017) Flexibility and innovation in FDA’s novel regulatory approval strategies for hematologic drugs. Blood 130:1285–1289
Farzan J (2011) Neue Pharmakovigilanz-Gesetzgebung in der EU. Bull Zur Arzneimittelsicherheit 2:14–17
FDA (2018a) For patients: priority review. https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405
FDA (2018b) Fast-track programs for drugs and medical devices. https://www.drugwatch.com/fda/fast-track/
Forda SR, Bergström R, Chlebus M, Barker R, Andersen PH (2013) Priorities for improving drug research, development and regulation. Nat Rev Drug Discov 12:247–248
Frank C, Himmelstein DU, Woolhandler S, Bor DH, Wolfe SM, Heymann O, Zallman L, Lasser KE (2014) Era of faster FDA approval has also seen increased black-box warnings and market withdrawals. Health Aff 33:1453–1459
Fujiwara Y, Ono S (2017) Regulatory review of new therapeutic agents. N Engl J Med 376:2598
Gemeinsamer Bundesausschuss (2016) Die Nutzenbewertung von Arzneimitteln gemäß § 35a SGB V. https://www.g-ba.de/institution/themenschwerpunkte/arzneimittel/nutzenbewertung35a/
Gonsalves G, Zuckerman D (2015) Commentary – Will 20th century patient safeguards be reversed in 21st century? BMJ 350:h1500
Gyawali B, Hey SP, Kesselheim AS (2019) Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Intern Med 179:906–913
Hartmann J, Schüßler-Lenz M, Bondanza A, Buchholz CJ (2017) Clinical development of CAR T cells – challenges and opportunities in translating innovative treatment concepts. EMBO Mol Med 9:1183–1197
Hatswell AJ, Baio G, Berlin JA, Irs A, Freemantle N (2016) Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014. BMJ Open 6:e11666
Health Action International (2015) Marketing authorisation flexibilities that enable early access to medicines should only respond to true unmet medical needs and must protect patients’ safety. https://haiweb.org/wp-content/uploads/2015/10/EMA-Consultation-Response-Conditional-Approval-Accelerated-Assessment.pdf
Herper M (2019) Attempt to replicate clinical trials with real-world data generates real-world criticism, too. https://www.statnews.com/2019/07/03/replicate-clinical-trials-real-world-evidence/
Hines PA, Guy RH, Humphreys AJ, Papaluca-Amati M (2019) The European Medicines Agency’s goals for regulatory science to 2020. Nature Rev Drug Discov 18:403–404
Hoekman J, Boon WP, Bouvy JC, Ebbers HC, de Jong JP, De Bruin ML (2015) Use of the conditional marketing authorization pathway for oncology medicines in Europe. Clin Pharmacol Ther 98:534–541
Hofer MP, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J (2015) Impact of scientifc advice from the European Medicines Agency. Nat Rev Drug Discov 14:302–303
Huber M, Keller-Stanislawski B (2013) Der Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz (PRAC). Bull Zur Arzneimittelsicherheit 4:18–20
Hudson KL, Collins FS (2017) The 21st century cures act – A view from the NIH. N Engl J Med 376:111–113
International Council for Harmonisation (ICH) (1994) The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions E1. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
International Council for Harmonisation (ICH) (2000) The common technical document. http://www.ich.org/products/ctd.html
IQVIA Institute for Human Data Science (2018) Global oncology trends 2018. Innovation, expansion and disruption. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/global-oncology-trends-2018.pdf?_=1533812168999
Kaplan RM (2019) Is the 21st century cures act a solution or a problem? https://www.theregreview.org/2019/05/07/kaplan-21st-century-cures-act/
Kesselheim AS, Avorn J (2017) New “21st Century Cures” legislation. JAMA 317:581–582
Kesselheim AS, Wang B, Franklin JM, Darrow JJ (2015) Trends in utilization of FDA expedited drug development and approval programs, 1987–2014: cohort study. BMJ 351:h4633
Korzilius H (2018) Wie schnell ist noch sicher? Dtsch Arztebl 115:A1926–1932
Lexchin J (2015) Post-market safety warnings for drugs approved in Canada under the notice of compliance with conditions policy. Br J Clin Pharmacol 79:847–859
Ludwig W-D (2015) Nutzenbewertung von Arzneimitteln im Bestandsmarkt: Weshalb ist sie für eine qualitativ hochwertige, wirtschaftliche Verordnung von Arzneimitteln unverzichtbar? In: Greiner W, Witte J (Hrsg) AMNOG-Report 2015. Nutzenbewertung von Arzneimitteln in Deutschland. Beiträge zur Gesundheitsökonomie und Versorgungsforschung, Bd. 8. medhochzwei Verlag, Heidelberg, S 240–260
Ludwig W-D (2017b) Zulassungsverfahren für neue Arzneimittel in Europa. In: Schwabe U, Paffrath D, Ludwig W-D, Klauber J (Hrsg) Arzneiverordnungs-Report 2017. Springer, Berlin, S 33–53
Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA (2018) Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med 378:439–448
Medicines Evaluation Board (2019) Regulatory science. https://english.cbg-meb.nl/about-meb/regulatory-science
Mende A (2016) Schneller, aber dennoch sicher. Pharmazeutische Zeitung. http://www.pharmazeutische-zeitung.de/index.php?id=63337
Moore TJ, Furberg CD (2014) Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US Food and Drug Administration: the class of 2008. JAMA Intern Med 174:90–95
Mullard A (2016) 2015 FDA drug approvals. Nat Rev Drug Discov 15:73–76
Mullard A (2017) 2016 FDA drug approvals. Nat Rev Drug Discov 16:73–76
Mullard A (2018) 2017 FDA drug approvals. Nat Rev Drug Discov 17:81–85
Mullard A (2019) 2018 FDA drug approvals. Nat Rev Drug Discov 18:85–89
Nabhan C, Klink A, Prasad V (2019) Real-world evidence – What does it really mean? JAMA Oncol 5:781–783
Naci H, Carter A, Mossialos E (2015) Why the drug development pipeline is not delivering better medicines. BMJ 351:h5542
Naci H, Wouters OJ, Gupta R, Ioannidis JPA (2017a) Timing and characteristics of cumulative evidence available on novel therapeutic agents receiving Food and Drug Administration accelerated approval. Milbank Quartely 95:261–290
Naci H, Smalley KR, Kesselheim AS (2017b) Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration. JAMA 318:626–636
Nagai S, Ozawa K (2016) Regulatory approval pathways for anticancer drugs in Japan, the EU and the US. Int J Hematol 104:73–84
OECD Health Policy Studies (2018) Pharmaceutical innovation and access to medicines. https://read.oecd-ilibrary.org/social-issues-migration-health/pharmaceutical-innovation-and-access-to-medicines_9789264307391-en#page1
Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M (2016) Pharmaceutical licensing and reimbursement in the European Union, United States, and Japan. Clinical Pharmacol Ther 100:626–632
Park JH, Rivière I, Gonen M, Wang X, Sénéchal B, Curran KJ, Sauter C, Wang Y, Santomasso B, Mead E, Roshal M, Maslak P, Davila M, Brentjens RJ, Sadelain M (2018) Long-term follow-up of CD19 CAR therapy in acute lymphoblastic leukemia. N Engl J Med 378:449–459
Patorno E, Schneeweiss S, Gopalakrishnan C, Martin D, Franklin JM (2019) Using real-world data to predict findings of an ongoing phase IV cardiovascular outcome trial: Cardivascular safety of linagliptin versus glimepiride. Diabetes Care. https://doi.org/10.2337/dc19-0069
Pease AM, Krumholz HM, Hines HH, Downing NS, Aminawung JA, Shah ND, Ross JS (2017) Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ 357:j1680
Prasad V, Kim C, Burotto M, Vandross A (2015) The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Intern Med 175:1389–1398
Prescire (2019) Public consultation on EMA Regulatory Science to 2025. https://english.prescrire.org/Docu/DOCSEUROPE/20190626_PrescrireResponseConsultationEMARegulatoryScience.pdf
Putzeist M, Mantel-Teeuwisse AK, Aronsson B, Rowland M, Gispen-de Wied CC, Vamvakas S, Hoes AW, Leufkens HGM, Eichler HG (2012) Factors influencing non-approval of new drugs in Europe. Nat Rev Drug Discov 11:903–904
Regnstrom J, Koenig F, Aronson B, Reimer T, Svendsen K, Tsigkos S, Flamion B, Eichler H-G, Vamvakas S (2010) Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol 66:39–48
Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel. Amtsblatt der Europäischen Gemeinschaften Nr. L 311 S. 67, ber. 2003 Nr. L 302 S. 40, 2014 Nr. L 239 S. 81; zuletzt geändert durch Art. 1 ÄndRL 2012/26/EU vom 25. Oktober 2012. Amtsblatt der Europäischen Gemeinschaften Nr. L 299 S. 1
Seoane-Vazquez R-MR, Alqahtani S (2016) Response to letter to the editor regarding Alqahtani et al Article on priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiol Drug Saf 25:745–746
Sherman RE, Li J, Shapley S, Robb M, Woodcock J (2013) Expediting drug development – the FDA’s new “breakthrough therapy” designation. N Engl J Med 369:1877–1880
Tafuri G, Stolk P, Trotta F, Putzeist M, Leufkens H-G, Laing RO, De Allegri M (2014) How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers’ views. Ann Oncol 25:265–269
Trotta F, Leufkens HGM, Schellens JHM, Laing R, Tafuri G (2011) Evaluation of oncology drugs at the European medicines agency and US food and drug administration: when differences have an impact on clinical practice. J Clin Oncol 16:2266–2272
U.S. Government Accountability Office (GAO) (2016) Drug safety: FDA expedites many applications, but data for postapproval oversight need improvement. http://www.gao.gov/products/GAO-16-192
Ujeyl M, Schlegel C, Walter S, Gundert-Remy U (2012) New drugs: evidence relating to their therapeutic value after introduction to the market. Dtsch Arztebl Int 109:117–123
Van Luijn JCF, Gribnau FWJ, Leufkens HGM (2006) Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization. Br J Clin Phamacol 63:159–162
Vermeer NS, Duijnhoven RG, Straus SMJS, Mantel-Teeuwisse AK, Arlett PR, Egberts ACG, Leufkens HGM, De Bruin ML (2014) Risk management plans as a tool for proactive pharmacovigilance: a cohort study of newly approved drugs in Europe. Clin Pharmacol Ther 96:723–731
Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates vom 31. März 2004 zur Festlegung von Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur. Amtsblatt der Europäischen Gemeinschaften Nr. L 136 S. 1; zuletzt geändert durch Art. 1 ÄndVO (EU) 1027/2012 vom 25. Oktober 2012, Amtsblatt der Europäischen Gemeinschaften Nr. L 316 S. 38
Verordnung (EG) Nr. 507/2006 der Kommission vom 29. März 2006 über die bedingte Zulassung von Humanarzneimitteln, die unter den Geltungsbereich der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates fallen. Amtsblatt der Europäischen Gemeinschaften Nr. L 92 S. 6
Verordnung (EG) Nr. 1394/2007 des Europäischen Parlaments und des Rates vom 13. November 2007 über Arzneimittel für neuartige Therapien und zur Änderung der Richtlinie 2001/83/EG und der Verordnung (EG) Nr. 726/2004. Amtsblatt der Europäischen Gemeinschaften Nr. L 324 S. 121, ber. Amtsblatt der Europäischen Gemeinschaften 2009 Nr. L 87 S. 174; zuletzt geändert durch Art. 2 ÄndVO (EU) 1235/2010 vom 15. Dezember 2010, Amtsblatt der Europäischen Gemeinschaften Nr. L 348 S. 1
Verordnung (EG) Nr. 1235/2010 des Europäischen Parlaments und des Rates vom 15. Dezember 2010 zur Änderung der Verordnung (EG) Nr. 726/2004 zur Festlegung von Gemeinschaftsverfahren für die Genehmigung und Überwachung von Human- und Tierarzneimitteln und zur Errichtung einer Europäischen Arzneimittel-Agentur hinsichtlich der Pharmakovigilanz von Humanarzneimitteln und der Verordnung (EG) Nr. 1394/2007 über Arzneimittel für neuartige Therapien
Wieseler B, McGauran N, Kaiser T (2019) New drugs: where did we go wrong and what can we do better? BMJ 366:l4340. https://doi.org/10.1136/bmj.l4340
Zerhouni E (2015) EMA: the next 5 years – the innovator’s perspective. https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-next-5-years-innovators-perspective-elias-zerhouni_en.pdf
Zeukeng M-J, Seoane-Vazquez E, Bonnabry P (2018) A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs. Eur J Clin Pharmacol 74:811–818
Zhang Y, Hueser HC, Hernandez I (2017) Comparing the approval and coverage decisions of new oncology drugs in the United States and other selected countries. J Manag Care Spec Pharm 23:247–254
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer-Verlag GmbH Deutschland, ein Teil von Springer Nature
About this chapter
Cite this chapter
Ludwig, WD. (2019). Zulassungsverfahren für neue Arzneimittel in Europa. In: Schwabe, U., Paffrath, D., Ludwig, WD., Klauber, J. (eds) Arzneiverordnungs-Report 2019. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-59046-1_2
Download citation
DOI: https://doi.org/10.1007/978-3-662-59046-1_2
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-662-59045-4
Online ISBN: 978-3-662-59046-1
eBook Packages: Medicine (German Language)