Evolving drug regulatory landscape in China: A clinical pharmacology perspective

Author:

Tang Weifeng1,Huang Ying2,Zhou Diansong3,Huang Yao2,Chen Yingxue3,Ren Song1,Li Yan3,Wu Shengqian2,Zhao Xiaoying2,Song Xuyang1,Wang Haidong2,Jin Yuwen2,Yu Hongtao1,Zhang Li3,Li Yunfei2,Boulton David1,Shen Kevin2

Affiliation:

1. Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences R&D, AstraZeneca Gaithersburg Maryland USA

2. AstraZeneca R&D Shanghai China

3. Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences R&D, AstraZeneca Waltham Massachusetts USA

Funder

AstraZeneca

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Reference37 articles.

1. The State Council The People’s Republic of China.http://www.gov.cn/zhengce/content/2015‐08/18/content_10101.htm. Accessed September 19 2020.

2. National Medical Products Administration.Technical guideline of new drug Phase I clinical study application.http://www.cde.org.cn/zdyz.do?method=largePage&id=5861485dbdae74a3(2018). Accessed September 19 2020.

3. Food and Drug Administration.Content and format of Investigational New Drug Applications (INDs) for Phase 1 studies of drugs including well‐characterized therapeutic biotechnology‐derived products.https://www.fda.gov/media/71203/download(1995). Accessed September 19 2020.

4. Food and Drug Administration.Content and format of INDs for Phase 1 studies of drugs including well‐characterized therapeutic biotechnology‐derived products. Questions and Answers.https://www.fda.gov/media/72284/download(2000). Accessed September 19 2020.

5. European Medicines Agency.Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products.https://www.ema.europa.eu/en/documents/scientific‐guideline/guideline‐strategies‐identify‐mitigate‐risks‐first‐human‐early‐clinical‐trials‐investigational_en.pdf(2017). Accessed September 19 2020.

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