China's reform of the regulatory system for medical products and its impact

• 来源期刊: 国家科学评论（英文版）
• 年，卷（期）: 2019,（1）
• 页码范围: 1
• 页数: 1页
• 语种: 英文
• DOI: 10.1093/nsr/nwz001

摘要

On 9 August 2015,the State Council of the People's Republic of China issued'The Opinions on Reforming Review and Approval Process for Drugs and Medical Devices' (GUOFA [2015] No.44).This important policy document not only provides the guideline for creating a more scientific and efficient regulatory process for drugs and medical devices,but also initiates the reform of the administration system for medical products in China.In October 2017,the general office of the Communist Party of China Central Committee and the general office of the State Council jointly announced'Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices',which systematically gives specific provisions for the reform of China's drug and medical-device regulatory system.Since 2017,the China Food and DrugAdministration (CFDA) has become a member of the International Council for Harmonization (ICH) and has begun to bring international standards into the drug regulatory process in China.After 3 years of efforts,tremendous progress has been made in the development of innovative drugs:the number of new drug applications (NDAs) is increasing;many new drugs are launched to the market;more and more Chinese medical products meet the international standards;and the pharmaceutical industry makes more contributions to the economic growth in China.