A Comparison of <scp>EMA</scp> and <scp>FDA</scp> Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

Kashoki, Mwango; Hanaizi, Zahra; Yordanova, Stella; Veselý, Richard; Bouygues, Christelle; Llinares, Jordi; Kweder, Sandra L.

doi:10.1002/cpt.1565

Cited by 61 publications

(74 citation statements)

References 7 publications

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“…Importantly, we found no further major divergences in regulatory outcomes for breast cancer drugs during the last ten years covered in our analysis (i.e., from 2009 to 2018; the two drugs approved by FDA in 2018, olaparib and talazoparib, both received an EU approval in the first half of 2019.) Our findings are in agreement with a recent analysis of new drug applications processed by the FDA and EMA between 2014-2016, which found 98% of final decisions to be concordant between the two agencies [13]. The increasing convergence of regulatory outcomes probably reflects a heightened harmonization of drug regulatory processes between the U.S.A. and Europe as well as more globally coordinated development and registration efforts by internationally active pharmaceutical companies.…”

Section: Discussionsupporting

confidence: 91%

“…Notwithstanding efforts to harmonize regulatory processes on an international level, EMA's structures and procedures diverge in various important aspects from those of the FDA. The different legal frameworks and political mandates of the two agencies can therefore result in differing regulatory timelines and/or approval decisions [12,13]. We found that 12 of the 29 breast cancer drugs in our analysis did not possess a dual approval for this tumor entity based on both the FDA and EMA review.…”

Section: Discussionmentioning

confidence: 84%

“…Since the review and approval of new drugs lie in the responsibility of national or regional authorities, approval decisions and timelines may diverge between different geographies. Previous studies comparing drug approval processes and outcomes in the United States and other countries/regions demonstrated that the U.S.A. approval process is generally the fastest [11][12][13]. Only very few publications specifically address the approval of new oncology drugs across different regulatory regions, and these are restricted to certain drug classes and/or date back to periods with differing regulatory environments for cancer drugs [14,15].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Leo¹,

Hentschel²,

Szucs

et al. 2020

Cancers

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Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 84%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Leo¹,

Hentschel²,

Szucs

et al. 2020

Cancers

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show abstract

“…Our findings that the EMA approval process benefits from additional items of information only for a minority of medicines are in line with the results of a comparison of the marketing applications assessed by both the EMA and the FDA between 2014 and 2016. This study showed high concordance in the final decisions on marketing approvals (91% when only the initial decisions were considered, up to 98% including resubmission and re‐examination) . Although this study did not focus on comparisons of times to submission and approval of an application, the authors reported that the main reason for (rare) discordant decisions was differences in conclusions about efficacy, followed by differences in the clinical data submitted.…”

Section: Discussionmentioning

confidence: 85%

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

Joppi

Bertelè

Vannini

et al. 2019

Brit J Clinical Pharma

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The Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted. In 2015-2017 the FDA licensed 113 drugs, 66 of which reached Europe. The median review time was longer at the EMA than FDA and was shorter for drugs undergoing FDA-expedited programmes compared to the same drugs approved by the EMA through the standard procedure. We identified differences regarding the evidence submitted to the 2 regulators for 7 drugs. The greater use of expedited programmes by the FDA and administrative time at the European Commission mainly explain the later access of new drugs to the European market. The additional evidence submitted to the EMA is generally scant and limited to a few drugs. K E Y W O R D S drug regulation, health policy, therapeutics 1 | BACKGROUND Regulatory agencies face constant pressure to speed up the development, review and approval of drugs for serious diseases. Both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) support clinical drug development and accelerated review and authorisation procedures (Box 1). 1 These programmes are intended to meet the expectations of drug manufacturers and patients, the former eager to launch new drugs promptly to maximise the return on investment and the latter to have access to potentially innovative therapies as soon as possible. Expedited programmes implemented by the FDA provide shorter overall review times than standard ones, 2 and account for the reportedly faster process than at the EMA. 3-6The earlier application and shorter review times at the FDA compared to the EMA may offer the European agency the possibility to assess the same drugs on the basis of more comprehensive information. To test this, we first assessed the delays in the application dates of the novel drugs-namely, new molecular entities and original biologic agents-licensed by both FDA and EMA, and compared their review times. Then we explored the differences in the evidence available at the time of EMA approval of medicines already licensed by the FDA through expedited programmes. | METHODSWe identified the drugs approved by the FDA from January 2015 through December 2017 using 3 reports published by the agency. [7][8][9] We extracted the date of approval, information on the type of authorisation procedure, and information on the evidence submitted in the marketing authorisation (MA) application from the Drugs@Fda database. 1,10 Review times in USA were calculated as the number of days elapsed from the Investigational New Drug application to the first FDA approval. Investigational New Drug application dates were obtained from FDA documents and administrative correspondence.We classified applications as either expedited or non-expedited procedures (Box 1).

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“…It was published recently however, that the concordance among pharmacogenomic drug labels between FDA, EMA, DPGW, and CPIC is low and of drugs considered by all agencies; for only 18% of them is the information similar across the four agencies (8). For pharmacogenomic drug labels provided by the FDA and the EMA (or the Dutch or the German MPAs), the concordance is low (8,9), in contrast to the high concordance between the FDA and the EMA regarding the approval of new drugs (10). Furthermore, the use of such labels in a clinical setting is relatively limited apart from in oncology (11).…”

Section: Introductionmentioning

confidence: 96%

Pharmacogenomics of Antidepressant and Antipsychotic Treatment: How Far Have We Got and Where Are We Going?

et al. 2020

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A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

Cited by 61 publications

References 7 publications

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

Pharmacogenomics of Antidepressant and Antipsychotic Treatment: How Far Have We Got and Where Are We Going?

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