EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

van der Laan, Jan Willem; Andersson, Mikael; Beken, Sonja; Bonelli, Milton; Brendler‐Schwaab, Susanne; Kane, Rosemary; Pasanen, Markku; Ponzano, Stefano; Paur, Jakob; Siezen, Christine; Soleng, Anne; Whomsley, Rhys

doi:10.1111/bcp.15790

Cited by 2 publications

(1 citation statement)

References 35 publications

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“…This pivotal change introduced in the ICH S1B(R1) guideline is expected to increasingly rely on new and alternative strategies for determining carcinogenic risk. This is in line with the 3Rs [Replacement, Reduction, and Refinement (Russell and Burch, 1959)] approach of animal use in science (Van Der Laan et al, 2023), that is embraced by several programs. For example, the FDA Modernization Act 2.0 gives the drug development industry the option to use alternatives to animal testing to determine safety and efficacy of drugs, empowering the use of innovative non-animal methods in the most rigorous and scientific way (US Congress, 2022;Wadman, 2023).…”

Section: Introductionsupporting

confidence: 64%

Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Bassan,

Steigerwalt,

Keller

et al. 2024

Front. Toxicol.

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The ICH S1B carcinogenicity global testing guideline has been recently revised with a novel addendum that describes a comprehensive integrated Weight of Evidence (WoE) approach to determine the need for a 2-year rat carcinogenicity study. In the present work, experts from different organizations have joined efforts to standardize as much as possible a procedural framework for the integration of evidence associated with the different ICH S1B(R1) WoE criteria. The framework uses a pragmatic consensus procedure for carcinogenicity hazard assessment to facilitate transparent, consistent, and documented decision-making and it discusses best-practices both for the organization of studies and presentation of data in a format suitable for regulatory review. First, it is acknowledged that the six WoE factors described in the addendum form an integrated network of evidence within a holistic assessment framework that is used synergistically to analyze and explain safety signals. Second, the proposed standardized procedure builds upon different considerations related to the primary sources of evidence, mechanistic analysis, alternative methodologies and novel investigative approaches, metabolites, and reliability of the data and other acquired information. Each of the six WoE factors is described highlighting how they can contribute evidence for the overall WoE assessment. A suggested reporting format to summarize the cross-integration of evidence from the different WoE factors is also presented. This work also notes that even if a 2-year rat study is ultimately required, creating a WoE assessment is valuable in understanding the specific factors and levels of human carcinogenic risk better than have been identified previously with the 2-year rat bioassay alone.

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Section: Introductionsupporting

confidence: 64%

Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Bassan,

Steigerwalt,

Keller

et al. 2024

Front. Toxicol.

View full text Add to dashboard Cite

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Enhancing Collaboration and Interdisciplinary Strategies for Navigating Innovative Technologies and Regulatory Approvals in the Cosmetic Industry

Shastri,

Gandhi,

Almeida

2024

COSCI

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The cosmetic industry, driven by innovation, constantly seeks safer, more effective, and sustainable products. However, regulatory hurdles often impede the introduction of innovative cosmetics. This paper explores the convergence of advanced technologies and regulatory conformity, emphasizing the need for collaborative, interdisciplinary approaches. Through an extensive review of literature and case studies, we reveal the multifaceted challenges within the industry. These encompass shifting consumer expectations, ingredient safety concerns, and intricate global regulations. Cross-functional collaborations, uniting researchers, regulators, industry experts, and consumers, are pivotal, driving innovation while ensuring product safety and compliance. Our research stresses the importance of a proactive, all-encompassing approach to product development. This approach should integrate cutting-edge technologies, rigorous safety assessments, and smart regulatory strategies from project inception. Additionally, it emphasizes engaging stakeholders, sharing knowledge, and practicing transparency to earn trust from consumers and regulators. This paper provides a comprehensive overview of the balance between innovation and regulation in the cosmetic industry, advocating for a paradigm shift characterized by collaboration and interdisciplinary efforts. By aligning innovation with regulatory compliance, the industry can effectively navigate the complex landscape of modern cosmetics, fostering the creation of safer, more sustainable, and consumer-centric products.

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EMA commentary on the ICH guideline for testing for carcinogenicity of pharmaceuticals

Cited by 2 publications

References 35 publications

Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Developing a pragmatic consensus procedure supporting the ICH S1B(R1) weight of evidence carcinogenicity assessment

Enhancing Collaboration and Interdisciplinary Strategies for Navigating Innovative Technologies and Regulatory Approvals in the Cosmetic Industry

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