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Chemical risk governance: Exploring stakeholder participation in Canada, the USA, and the EU.

ABSTRACT: Hazardous chemicals are one of the greatest environmental challenges facing our planet, testing governments in the face of economic and social development. Chemical risks are often complex systemic risks, which require particular governance processes, stakeholder participation mechanisms, and communication procedures to manage. In this article we explore how such processes, mechanisms, and procedures could offer more effective pathways for international chemical risk assessment and management. Combining document analysis with 69 key informant interviews and four focus groups with experts from across government, non-governmental organizations (NGOs) and industry in Canada, the USA and Europe (n = 24), the results highlight the importance of increasing stakeholder participation and risk communication in existing chemical risk assessment and management frameworks. Similarities and differences between the three jurisdictions are discussed with a view to inform future risk governance strategies. The contemporary insights are of relevance to decision-makers seeking to improve the effectiveness of chemical risk governance in practice.

SUBMITTER: van der Vegt RG

PROVIDER: S-EPMC9110598 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Chemical risk governance: Exploring stakeholder participation in Canada, the USA, and the EU.

van der Vegt R G RG Maguire Steven S Crump Doug D Hecker Markus M Basu Niladri N Hickey Gordon M GM

Ambio 20211206 7

Hazardous chemicals are one of the greatest environmental challenges facing our planet, testing governments in the face of economic and social development. Chemical risks are often complex systemic risks, which require particular governance processes, stakeholder participation mechanisms, and communication procedures to manage. In this article we explore how such processes, mechanisms, and procedures could offer more effective pathways for international chemical risk assessment and management. C ...[more]

PMID: 34870781

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Project description:Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges. Materials and Methods: The current valid guidelines of EMA, WHO, USFDA, BGTD/HC, ICH, and BRICS-TM were obtained from official websites and comparative qualitative review was performed. Results: The review revealed that Health Canada uses mAb specific guidelines from EMA or USFDA when necessary. The BRICS agencies (except Russia) have incorporated some or most of the WHO SBP TRS and related annexes in similar national biotechnological/biological guidelines; however, gaps or insufficient information have been identified. The Russian Federation has issued general product registration guideline/s with very brief information about mAbs. The TMMDA (Turkey) has published an updated biosimilar guideline which parallels those of the EMA and the ones from WHO; however, no mAb specific guidelines are published. COFEPRIS (Mexico) has published a biotechnological/biological product registration guideline with no information about mAb. The SAHPRA biosimilar guideline has an annex on mAbs which focuses on non-clinical and clinical aspects. The comparative evaluation of BRICS-TM agencies indicates a gap pertaining to clarification for physico-chemical characterization, manufacturing process, overages and compatibility requirements between biological substances and excipients specifically on mAbs. In vitro assay requirements seem quite aligned with those of WHO, whereas in vivo studies mostly have disparity in terms of necessity, type of studies as well as design and criteria. Clinical safety and efficacy studies are indicated in emerging regulatory agencies, however detailed information pertaining to design, size of populations, requirements for primary and secondary endpoints, clarity and evaluation criteria differ. In general, BRICS-TM agencies allow extrapolation of indications provided that pre-defined conditions are met. Interchangeability, switching and substitution of biosimilars are not defined in most of BRIC-TM guidelines whereas South Africa, by law, allows neither interchangeability nor substitution. Pediatric research remains questionable across BRICS-TM. Conclusions: EMA, USFDA guidelines are broadly aligned with WHO and in addition, they also contain specific requirements pertaining to their own region. BRICS-TM has considerably less defined mAb specific biosimilar development and comparability parameters in their published guidelines.

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Dataset Information

Chemical risk governance: Exploring stakeholder participation in Canada, the USA, and the EU.

Publications

Chemical risk governance: Exploring stakeholder participation in Canada, the USA, and the EU.

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