If you’ve only recently taken an interest in the healthcare sector in China, you may be confused by some of the acronyms you see floating around, and wonder why there seem to be multiple agencies doing the same jobs. You’ll be pleased to hear that the confusion in some English language publications mainly results from a change of name and that, in fact, the situation is much simpler than it looks.
On 1 September 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association). While the two are not exactly the same (with some reorganisation having taken place), from the perspective of foreign companies wanting to work with Chinese CROs, little has changed. There’s only one major difference that’s likely to affect you: the submissions process can now be carried out entirely in electronic form.
Why the change of format?
With more and more foreign healthcare companies taking an interest in China, medical device registration risked becoming increasingly slow and cumbersome. By late 2017, it was obvious that it would need to be overhauled. The Chinese government took the problem seriously and made it a priority as part of their wider effort to reduce hurdles for prospective foreign investors.
Through the new body, which answers directly to the Ministry of Health, applications should move a lot faster. The shift to an electronic format makes it easier to streamline the process and keep track of applications as they move through the system. In the event that not enough information is submitted or the information appears to be incorrect, you should be contacted about this and have the opportunity to fix it before the final submission is made. This should reduce the number of rejections, saving everybody time and trouble.
The rebranding and restructuring of the CFDA represents the latest step in China’s approach to upgrading its clinical research regulations. This is happening in parallel with a massive investment in healthcare infrastructure right across the country, the aim being to make dramatic improvements in the quality of healthcare available to Chinese citizens, and in what China is able to contribute to the sector internationally. Determined to become a top player in the development of healthcare technologies, the country is trying to facilitate easier engagement with foreign companies to encourage investment and joint ventures.
The NMPA is specifically charged with establishing and improving the quality of new medicines and medical devices, and with establishing a framework that attracts further research and development. In setting out to achieve this, it has prioritised both the speeding up of the applications process and increasing transparency within the system. There has also been a process in tightening up standards so that in China clinical trial quality is as high as that found in countries such as the UK, the US and Canada.
Simplifying access for foreign companies
During its review of the previous system, the NMPA identified two major concerns among foreign drug companies, both of which have now been addressed. Firstly, it dropped the requirement that for any new device or drug to be marketed in China clinical trials must have been conducted there: some forms of data from outside the country are now eligible for use in applications. Secondly, it reduced the bureaucracy facing foreign companies and made it possible for them to apply for their products to be approved for use in China, even if they did not have prior approval in another country. It remains necessary for foreign companies to submit applications in both Chinese and their native language, but this is seen as vital because it makes it easier to identify any language errors and ensure accuracy.
The NMPA has two internal departments for dealing with medical devices: one for pre-market approval and one for post-market approval. It no longer deals with food safety as its predecessor did, so is able to focus its efforts more heavily on these areas. Overseen by the State Administration for Market Regulation, it benefits from a broader focus on consistency and a zero-tolerance approach to corruption, which is intended to keep quality high.
By making these changes during the development of the NMPA, China has significantly enhanced its ability to comply with international standards and thus speed up the work it can do with other countries. This is particularly notable in relation to its priority review system, which now makes rapid international engagement possible where new products need to be developed and reviewed urgently in order to meet high-priority emerging healthcare needs.
Better organised and more efficient than its predecessor, the NMPA is shaping up to be everything that healthcare developers had hoped for. For users who previously had satisfactory experiences with the CFDA it may not seem very different, but a positive experience is now the norm.