Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

doi:10.1186/s13020-021-00433-2

. 2021 Feb 16;16(1):23.

doi: 10.1186/s13020-021-00433-2.

Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

Zuanji Liang¹, Yunfeng Lai¹, Meng Li¹, Junnan Shi¹, Chi Ieong Lei¹, Hao Hu¹, Carolina Oi Lam Ung²

Affiliations

¹ State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Science, University of Macau, Macao, Taipa, China.
² State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Science, University of Macau, Macao, Taipa, China. carolinaung@um.edu.mo.

PMID: 33593397
PMCID: PMC7884970
DOI: 10.1186/s13020-021-00433-2

Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

Zuanji Liang et al. Chin Med. 2021.

. 2021 Feb 16;16(1):23.

doi: 10.1186/s13020-021-00433-2.

Authors

Zuanji Liang¹, Yunfeng Lai¹, Meng Li¹, Junnan Shi¹, Chi Ieong Lei¹, Hao Hu¹, Carolina Oi Lam Ung²

Affiliations

¹ State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Science, University of Macau, Macao, Taipa, China.
² State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Science, University of Macau, Macao, Taipa, China. carolinaung@um.edu.mo.

PMID: 33593397
PMCID: PMC7884970
DOI: 10.1186/s13020-021-00433-2

Abstract

Background: The National Medical Products Administration (NMPA) in China has set to advance the regulatory capacity of traditional Chinese medicines (TCMs) with the adoption of regulatory science (RS). However, the priority of actions at the interface of RS and TCMs were yet to be defined. This research aims to identify the priority areas and summarize core actions for advancing RS for traditional medicines in China.

Methods: A mixed approach of documentary analysis of government policies, regulations and official information about TCMs regulation in China, and a scoping review of literature using 4 databases (PubMed, ScienceDirect, Scopus and CNKI) on major concerns in TCMs regulation was employed.

Results: Ten priority areas in the development of TCM-related regulatory science in China have been identified, including: (1) modernizing the regulatory system with a holistic approach; (2) advancing the methodology for the quality control of TCMs; (3) fostering the control mechanism of TCMs manufacturing process; (4) improving clinical evaluation of TCMs and leveraging real world data; (5) re-evaluation of TCMs injection; (6) developing evaluation standards for classic TCMs formula; (7) harnessing diverse data to improve pharmacovigilance of TCMs; (8) evaluating the value of integrative medicine in clinical practice with scientific research; (9) advancing the regulatory capacity to encourage innovation in TCMs; and (10) advancing a vision of collaboration for RS development in TCMs.

Conclusions: RS for TCMs in China encompasses revolution of operational procedures, advancement in science and technology, and cross-disciplinary collaborations. Such experiences could be integrated in the communications among drug regulatory authorities to promote standardized and scientific regulation of traditional medicines.

Keywords: China; Drug Regulatory Authority; National Medical Products Administration; Regulatory Science; TCM; Traditional medicine.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
The process of advancing RS for TCMs in China

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References

1. Gispen-de Wied CC, Leufkens HGM. From molecule to market access: drug regulatory science as an upcoming discipline. Eur J Pharmacol. 2013;719(1–3):9–15. - PubMed
1. US Food and Drug Administration. Advancing regulatory science at FDA: a strategic plan. 2011. https://www.fda.gov/media/81109/download. Accessed 30 Jun 2020.
1. European Medicines Agency. Regulatory Science Strategy to 2025. 2019. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/e.... Accessed 30 Jun 2020.
1. Japanese Pharmaceuticals and Medical Devices Agency. Outline of regulatory science. https://www.pmda.go.jp/english/rs-sb-std/rs/0003.html. Accessed 30 Jun 2020.
1. The Center People’s Government of the PRC. NMPA has initiated the “Action Plan on Regulatory Science in China. http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm. Accessed 30 Jun 2020 (Chinese).

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[1] Gispen-de Wied CC, Leufkens HGM. From molecule to market access: drug regulatory science as an upcoming discipline. Eur J Pharmacol. 2013;719(1–3):9–15. - PubMed

[2] Gispen-de Wied CC, Leufkens HGM. From molecule to market access: drug regulatory science as an upcoming discipline. Eur J Pharmacol. 2013;719(1–3):9–15. - PubMed

[3] US Food and Drug Administration. Advancing regulatory science at FDA: a strategic plan. 2011. https://www.fda.gov/media/81109/download. Accessed 30 Jun 2020.

[4] US Food and Drug Administration. Advancing regulatory science at FDA: a strategic plan. 2011. https://www.fda.gov/media/81109/download. Accessed 30 Jun 2020.

[5] European Medicines Agency. Regulatory Science Strategy to 2025. 2019. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/e.... Accessed 30 Jun 2020.

[6] European Medicines Agency. Regulatory Science Strategy to 2025. 2019. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/e.... Accessed 30 Jun 2020.

[7] Japanese Pharmaceuticals and Medical Devices Agency. Outline of regulatory science. https://www.pmda.go.jp/english/rs-sb-std/rs/0003.html. Accessed 30 Jun 2020.

[8] Japanese Pharmaceuticals and Medical Devices Agency. Outline of regulatory science. https://www.pmda.go.jp/english/rs-sb-std/rs/0003.html. Accessed 30 Jun 2020.

[9] The Center People’s Government of the PRC. NMPA has initiated the “Action Plan on Regulatory Science in China. http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm. Accessed 30 Jun 2020 (Chinese).

[10] The Center People’s Government of the PRC. NMPA has initiated the “Action Plan on Regulatory Science in China. http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm. Accessed 30 Jun 2020 (Chinese).

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Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

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Applying regulatory science in traditional chinese medicines for improving public safety and facilitating innovation in China: a scoping review and regulatory implications

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Affiliations

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Conflict of interest statement

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