The Key to Successfully Navigating Chinese Pharmaceutical Regulations
The Chinese regulatory landscape is very different compared to that of the rest of the world. Can businesses bridge the gap between the East and West?
Dr. Aviral Maheshwari
Vice President at Prescient Healthcare Group
China’s approval process
Unlocking China’s secrets is not just about overcoming cultural reticence; China’s approach to data sharing is very different from that of the West. In the US, for example, data are highly regulated and are centralized; China, by contrast, has much greater variance, with data spread across a number of local and national authorities.
China’s tendency for decentralization has muddied processes such as drug approval, but this is beginning to shift: Prior to 2015, receiving approval for the Phase I clinical trial of a new drug could take 20 months or longer thanks to a shortage of the CFDA staff, which has created a backlog of cases, as well as prioritization being given to domestic generics manufacturers. With the technical review committee expanding from 150 to over 1,000 members, this backlog is now being tackled, but the approval process is still by no means standardized or predictable.
Does the addition of the CFDA staff mean that the approval timeline in China is now comparable to that in the US? Not quite: After the policy reforms of 2015, the approval process for generics in China is expected to take 180-210 days, but the review process can still extend to 13-15 months in some cases.
In China, uncertainty remains a significant hurdle for pharmaceutical companies with regards to launch and marketing timelines, and this uncertainty is more pronounced for multinational companies than it is for domestic manufacturers.
The 70/30 policy
Opportunities offered by China to the rest of the world and vice versa
The interest in opportunities goes two ways, with China looking at the West and considering that what it is capable of offering may answer the needs of the rest of the world.
We previously noted that generics companies from India have better access to APIs in China; other manufacturers around the world may follow suit, as APIs are the one area within the pharmaceutical industry in which China can claim dominance. China is also looking at the West’s medical device market and seeing opportunities that fall squarely in its comfort zone of manufacturing at high speeds and low costs. While HCPs in the West are keen to utilize China’s low-cost, high-quality manufacturing, those in China desire Western R&D expertise. Both sides see potential markets in each other and are exploring ways to deepen relationships.