Are Regulators Talking to Each Other Across Borders?

Graaf, Piet H. van der

doi:10.1002/cpt.1761

Cited by 3 publications

(3 citation statements)

References 20 publications

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“…Regulatory science is often focusing on the estimation and prediction of safety and efficacy for the patient‐centered development drugs and medical devices 26,27 . Nevertheless, evaluation of the performance and review quality may be an approach of regulatory science in a broad sense.…”

Section: Discussionmentioning

confidence: 99%

“…Regulatory science is often focusing on the estimation and prediction of safety and efficacy for the patient-centered development drugs and medical devices. 26,27 Nevertheless, evaluation of the performance and review quality may be an approach of regulatory science in a broad sense. In this study, we listed the drugs with NASs approved in Japan in the last 12 years, revealed the proportion of the new drugs first approved in Japan prior to the other countries, compared the global developments with domestic developments, and found the change of the drug lag with certain improvement and some still need help.…”

Section: Articlementioning

confidence: 99%

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Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

Tanaka

Idei

Sakaguchi

et al. 2020

Clin Pharma and Therapeutics

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The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first-in-world approvals and clarify the current drug lag. The new drug and the drug lag were defined as a drug with a new active substance and a difference between the approval date in Japan and the international birth date, respectively. Among 400 new drugs approved in Japan during the last 12 years, 80 (20.0%) were first approved in Japan, and 320 were outside Japan (the United States: 202, 50.5%; Europe: 82, 20.5%; other regions: 36, 9.0%). Of these, 45 new drugs have not yet been approved outside Japan, and the remaining 355 have been globally approved in Japan and overseas. The number of new drug approvals were the largest in oncology followed by metabolic/endocrine and infectious diseases. The median drug lags (year) among all 400 new drugs and 355 new drugs with global approvals were 4.3 and 4.7 in the first tertile (2008-2011), 1.5 and 2.6 in the second tertile (2012-2015), and reduced to 1.3 and 2.2 in the third tertile (2016-2019), respectively. Substantial drug lag remains in neurology, psychiatry, and therapeutic areas where the number of new drug approvals was relatively small. Collectively, one-fifth of the new drugs approved in Japan are first-in-world approvals. Drug lag has been greatly decreased, although it still exists. The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory authority that protects the public health by securing safety, efficacy, and quality of drugs and medical devices. For a new drug approval, the PMDA conducts a scientific review on the product application according to the legislations in Japan, and after PMDA approval, Ministry of Health, Labor, and Welfare (MHLW) administratively grants the marketing authorization for the product based on the review report from the PMDA. Acquiring the first-in-world approval for marketing authorization of new drugs yields several benefits in their own country,

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Section: Discussionmentioning

confidence: 99%

Section: Articlementioning

confidence: 99%

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

Tanaka

Idei

Sakaguchi

et al. 2020

Clin Pharma and Therapeutics

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“…This observation is consistent with other recent studies that compared EMA and FDA decision making 5 and indicates an evolution compared with a previous analysis 13 that found that between 1995 and 2009, the European Union rejected 31 applications that the United States approved, whereas the United States rejected 24 applications that the European Union approved. We propose that the increased observed level of alignment in recent years between the 2 regulators suggests that engagement processes (eg, providing parallel scientific advice [14][15][16] ), formalization and standardization of benefit risk frameworks, and collaboration on regulatory science have had a positive impact on the regulatory decision-making process, and we hope that further improvements in these areas will facilitate even greater transparency and consistency in decision making. This alignment is reflected in our prior study 4 in which we found a 73% concordance for decisions on indication where the same indication was submitted by the sponsor to both agencies.…”

Section: Discussionmentioning

confidence: 99%

Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?

Bujar

Ferragu

McAuslane

et al. 2021

Clinical Therapeutics

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Although it cannot be expected that different medicines' regulatory agencies always reach the same review outcome, it is important that decision making is documented and communicated to ensure transparency. This study examines whether justification for divergences between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding approved indications could be identified from the agencies' public assessment reports (PARs). We focused on 9 products previously identified to have been submitted simultaneously to both agencies with the same indication but had a different indication approved; there were 15 differences in indications. Our analysis confirms that the rationale for observed divergent indication decisions was predominantly found in the benefit-risk section of the PAR (9 of 15 cases for the FDA and 10 of 15 for the EMA). If not found in the benefit-risk section, the rationale for these decisions was found in other PAR sections (eg, labeling or clinical efficacy section) or not at all. Our study found a small number of inconsistencies or gaps in how, where, and whether regulatory decision making on approved indications are documented by the FDA and the EMA. We believe it is important for regulators to standardize their approach and systematically and transparently document their rationale for the approved indication, using a structured benefit-risk assessment format within the PAR. This process is especially important for innovative products for which experience in evaluating similar products worldwide is limited, particularly as agencies are striving to build effective regulatory processes by leveraging assessments by trusted reference agencies through approaches such as reliance. Clear and systematic communication and documentation of the decisions in the PAR are central and should continue to evolve as a best practice; an enabling step toward this would be a harmonized PAR template for use by agencies globally.

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Clinical Pharmacology and Therapeutics: 2020 in Review

Graaf

2020

Clin Pharma and Therapeutics

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Are Regulators Talking to Each Other Across Borders?

Cited by 3 publications

References 20 publications

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis

Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?

Clinical Pharmacology and Therapeutics: 2020 in Review

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