According to the report, the new legislation could create various pitfalls for partnerships and research projects as well as increase the fees for the cost of entry into the Chinese pharma market. The new ordinances come after another extensive cyber-security law, which was set in place last year, stating that data must be hosted on servers on the Chinese mainland.
Merck & Co, developer of Gardasil and Gardasil 9 which recently got approved by Chinese authorities, have earned millions of dollars for their Zhifei Biological Products. It has also spurred two Chinese families into Bloomberg’s ranking of the world richest people.
Though the US stands first in the race in terms of sales and growth, it is highly believed that China would reach the peak in the pharma market by 2022. At present, since there has been a decrease in public health funding, there has been a slight fall in pharmerging countries like Brazil, Russia, India and China (BRIC). But it is believed that the condition of these pharmerging countries will improve in the next five years .
Patients and Beijing residents are currently benefitting from the new electronic health cards issued by Beijing through the WeChat app; the program is facilitated by Tencent and Sinosoft Technology which is aimed to improve the healthcare services by 2030 through digital cards.
The two sessions (NPC & CPPCC) this year have received much attention from China and outside China, wherein, the most-watched theme is “reform”. Regarding pharmaceuticals, the event that attracts the highest attention is CFDA reform, followed by policy moves of the TCM issue and bio-medicine, etc. that China has been strongly supporting in recent years.
Explosive growth and groundbreaking digital transformations are underway in China’s enormous healthcare market, and now a Beijing hospital has become the first private healthcare organisation in the nation to achieve Stage 6 on the HIMSS EMRAM scale for its electronic medical record system.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
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