China is a highly attractive clinical trial destination, and continues to see increased interest from CROs and drug development companies. China has a well-established tradition of developing medicines from basic research and the demands for modern pharmaceuticals is growing. Data gathered from clinicaltrials.gov indicated that in 2014, China had conducted 846 clinical trials, and an upward trajectory is expected to continue. For example, the number of registered interventional studies in China has increased almost 90% between 2008 and 2013.
On May 27th, 2015, The China Food and Drug Administration (CFDA) issued a new fee structure that dramatically increases the drug registration fees in China. Although the drugs and medical device registration fee for clinical trials is applied in many countries such as Australia and the United States, China has a significant shortfall of resources to meet the increasing number of new drug registrations. Currently, CFDA is estimated to only have 120 reviewers.
By the end of 2014, China had backlogged 18,597 applications – which is an increase of 30% from the previous year. China plans on decreasing this figure through increasing staff numbers, reducing redundancies and provide lucid guidance to companies.
The previous clinical trial and drug registration fee for a local product was introduced in 1995 and amounted to 6,000RMB. In comparison to countries such as the United States, Australia and Japan, China maintains a significantly lower fee. The fees vary depending on the drug category. Fees have significantly risen across the board, but remain lower for local products.
For example, the new drug registration fee for a local product has risen by 1682% and amounts to 624,000RMB – approximately $100,000 USD – from 35,000RMB. Whereas, the fee to register a new imported drug has increased by 2041% amounting to 969,900RMB – approximately $159,400 USD – as opposed to paying 45,300RMB.
Although the fees will affect companies who are wanting to register a new drug In China, the change may provide a positive impact towards the Chinese clinical trial industry. The increased revenue for CFDA could strengthen the agency as well as China’s regional regulators and can lead to a decrease in review times. As a result of this, China will be able to invest further training in investigators, site coordinators and reviewers. Furthermore, the new cost requirements will expedite the approval process within CFDA as they look to appoint more officers in CFDA.
With the fee increase in new drug registration, companies and pharma’s must proceed with more caution as to who they collaborate with in China when conducting clinical trials. This is against a backdrop of already high costs of conducting clinical trials in China as companies often have to spend additional funds on training investigators and personnel, translation and shipping. In order to reduce their risk and ensure the successful implementation of a clinical trial, it is vital to select a full service CRO that has a strong on the ground presence in China. The selected CRO must possess a positive reputation, investigator networks in addition having extensive working experience in China.