Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

Honig, Peter K.; Zhang, Lei

doi:10.1002/cpt.1367

Cited by 9 publications

(6 citation statements)

References 19 publications

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“…Beyond science and technological innovation, as shown by the COVID-19 pandemic, drug regulation has seen challenges in engaging collaborative effort and formulating regulatory flexibility in advancing responses to unexpected public health threats ( 3 ). Regulators play an integral role in the complex ecosystem of the pharmaceutical system and often face the challenges of meeting societal expectations to provide patients with timely access to new treatment options while maintaining stakeholder trust by evidently upholding high regulatory practice standards ( 4 ).…”

Section: Introductionmentioning

confidence: 99%

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

Shi

Chen

et al. 2023

Front. Public Health

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IntroductionThe purpose of developing and adopting regulatory science (RS) for drug regulatory authorities (DRAs) is to enhance regulatory capacity by advancing the scientific approach for the evaluation of health-related products. While many DRAs around the world advocate the concept of RS, the implementation approaches of RS vary according to local needs and have not been systemically examined. This study aimed to systematically identify the evidence about how RS was developed, adopted, and advanced by the selected DRAs, and analyzed and compared the implementation experiences of RS development under the guidance of an implementation science framework.MethodsDocumentary analysis of government documents and a scoping literature review were conducted, and data analysis was performed under the guidance of the PRECEDE-PROCEED Model (PPM). DRAs in the United States, the European Union, Japan, and China had officially launched RS initiatives and were therefore selected as the target countries in this study.ResultsThere is no common consensus on the definition of RS among the DRAs. However, these DRAs shared the same goal of developing and adopting RS, which was used to develop new tools, standards, and guidelines that could improve the effectiveness and efficiency of the risk and benefit assessment of the regulated products. Each DRA had decided its own priority areas for RS development and thus set specific objectives that might be technology-based (e.g., toxicology and clinical evaluation), process-based (e.g., partnership with healthcare systems and high-quality review/consultation services), or product-based (e.g., drug-device combination products and innovative emerging technologies). To advance RS, considerable resources had been allocated for staff training, advancing information technology and laboratory infrastructure, and funding research projects. DRAs also took multifaceted approaches to expand scientific collaborations through public–private partnerships, research funding mechanisms, and innovation networks. Cross-DRA communications were also reinforced through horizon scanning systems and consortiums to better inform and assist the regulatory decision-making process. The output measurements might be scientific publications, funded projects, DRAs interactions, and evaluation methods and guidelines. Improved regulatory efficiency and transparency leading to benefits to public health, patient outcomes, and translation of drug research and development as the key primary outcomes of RS development were anticipated but not yet clearly defined.ConclusionThe application of the implementation science framework is useful for conceptualizing and planning the development and adoption of RS for evidence-based regulatory decision-making. Continuous commitment to the RS development and regular review of the RS goals by the decision-makers are important for DRAs to meet the ever-changing scientific challenges in their regulatory decision-making process.

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Section: Introductionmentioning

confidence: 99%

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

Shi

Chen

et al. 2023

Front. Public Health

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“…Regional and national policy interventions can be important tools to stimulate and foster R&D investment in the pharmaceutical industry and improve access to new medicines. Pharmaceutical regulatory policy can impact development and access to pharmaceutical innovation by providing incentives and offering regulatory flexibility ( 10 ).…”

Section: Introductionmentioning

confidence: 99%

Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights

et al. 2022

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Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.

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“…2,6) 임상 시험 평가 방법 개발, 평가 기준 정립 등 규제과학은 규정 의 이해와 관련되며 제품의 허가와 관련된 규제 업무(regulatory affairs)와는 다르다. 1,6,7) 다양한 연구를 통해 규제과학은 새로 운 첨단 제품을 환자와 사회에 전달하는 가교 역할을 수행한 다. 우수한 신제품을 개발하였는데, 필요한 규제과학이 발달 하지 못해 이를 평가할 수 있는 방법과 기준이 정립되지 않았 다면 신제품은 시장에 진입하기 어렵다.…”

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Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea

Park

Shin

Kim

et al. 2021

Korean J Clin Pharm

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Background:The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

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Regulation and Innovation: Role of Regulatory Science in Facilitating Pharmaceutical Innovation

Cited by 9 publications

References 19 publications

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

Application of implementation science framework to develop and adopt regulatory science in different national regulatory authorities

Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights

Analysis of Trends in Regulatory Science and Regulatory Science Experts Training Projects: US, Japan, Singapore, and Korea

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