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Cooperate on regulatory policies Ensure internationally harmonized, smoothly functioning approval procedures
and Encouraging the Innovation of Drugs and Medical Devices117.
In the highly regulated health care sector, national regulatory approval procedures ensure the quality of products on the market. They play a critical role in determining if an innovative medical product able to improve diagnosis and treatment will become available to patients. Harmonized quality and approval procedures can facilitate simultaneous product development programs worldwide and ensure quicker availability of products across markets. In addition, smart regulation, well-staffed regulatory authorities, and well-trained personnel help prevent delays in approving much needed new medical products. Better regulatory approval is at the heart of the Chinese government’s reforms.
– MedTech: The NMPA is moving forward with generally positive reforms to medical device supervision by announcing amendments to Order No. 680. Under the NMPA predecessor, testing institutes in 2017 nevertheless “… received insufficient funding, causing serious delays to the registration of medical devices.”118 The amendment allowed for use of alternative testing facilities or self-testing reports, a measure that was warmly welcomed as help for remedying this serious industry concern. However, further clarification of the concepts set out in the amendment is required, e.g., which “qualified” testing institutes are recognized and the criteria that self-testing reports need to meet. Furthermore, implementation of the amendment is not yet complete.
Core challenges:
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Building capacity: In addition to enormous capacity building efforts, the Chinese government and the National Medical Products Administration (NMPA) have taken a number of positive, much needed steps toward creating a more smoothly functioning regulatory process. This includes the Opinion on Deepening the Reform of the Review and Approval System
– Pharma: Initial achievements include an impressive reduction in the former China Food & Drug Administration´s (CFDA’s) drug application 117
State Council, Opinion on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices, www. gov.cn/gongbao/content/2017/content_5232362 (accessed on 17.07.2020).
118
European Union Chamber of Commerce in China (2018), Healthcare Equipment Working Group, pp. 240, https://www.europeanchamber.com.cn/en/ publications-archive/727/Healthcare_Equipment_Working_Group_Position_ Paper_2019_2020. (accessed 29.5.2019).
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