What To Consider When Submitting An Application To The National Drug Administration of China

It has been widely publicized that there have been sweeping regulatory reforms over the last two years in China.  Five to seven years ago, China was one of the last countries where a foreign company would seek approval; now foreign customers with global plans are actively seeking to do their Phase I trials in China. The regulatory reforms offer huge opportunities for companies with the right strategy, especially, with China being the 2^nd largest pharmaceutical market in world and an aging population and an expanding middle class. 

Companies that are looking to submit to CNDA/CDE need to consider a number of new policies when mapping out their regulatory strategy. Some of the major regulatory reforms include:

• Streamline the clinical trial-start-up and China market access process,
• Addition of accelerated pathways, which shorten review times for both clinical trial and drug approvals,
• Adoption of harmonized, international standards,(e.g. ICH)
• Acceptance of  foreign data to support clinical studies and submissions,

• Removal of the import tax on cancer drugs; and the requirement for batch testing of imported drugs—both moves will lessen burden on foreign manufacturers

In addition to the regulatory reforms, the Chinese government has also made a number of additional changes to facilitate growth of the health industry including:

• Establishment of an intellectual property (IP) office and strengthening of intellectual property protection by drafting a new IP protection regulation, to protect inventors' patents and intellectual property rights.
• Investing a huge amount of capital and formulating policies to encourage the development of the local medical tourism industry, hoping to attract patients from all over the world to come to China
• Announcement recently that the Haian Province will be the first region where foreign approved medications and medical devices can be directly imported without CNDA approval if they address unmet medical needs
• Encouraging the development of digital Health, the application of artificial intelligence in the medical field, and wearable, intelligent medical devices and equipment.

Parexel's clinical and regulatory experts that support clients developing drug and devices in China recommend the three “pre-requisite” areas for a successful strategy.

#1 Have a Global Plan – Understand the regulations in all the major markets to make sure their product meets specific requirements and this regulatory understanding needs to include China which may support simultaneous submissions of marketing applications to multiple regions. At Parexel, we keep abreast of the changing requirements with a capable team of former regulators from agencies around the world, including FDA, MHRA, PMDA and CNDA.

#2 Gather Local Intelligence - Despite a commitment to harmonization and standardization vis-à-vis US, EU, ICH, etc., China still presents a unique challenge for biopharmaceutical companies. Companies need both a deep expertise and a well-researched strategy and need to think about China at the start of product development, not during the middle or end. Although there are limitations on the availability of clinical research sites, there are work-arounds. For example, PAREXEL partners with Chinese universities to conduct Phase 1 studies. By including Chinese subjects starting in Phase I, it is possible to detect ethnic variations early on compared to Western subjects—such as differences in drug metabolism, absorption, distribution, elimination, safety, tolerability and in pharmacodynamic profiles. Collecting this information early is a significant advantage.

#3 Secure Reimbursement - China has a reimbursement system that is fragmented across 34 provinces (Note: 34 provincial-level administrative units: 23 provinces, 4 municipalities (Beijing, Tianjin, Shanghai, Chongqing), 5 autonomous regions (Guangxi, Inner Mongolia, Tibet, Ningxia, Xinjiang) and 2 special administrative regions (Hong Kong, Macau). Working knowledge by region, province, and locality is critical, as drugs that get on national reimbursement list must win pricing/reimbursement in each province. Prioritizing provinces by size and impact is a key to efficient reimbursement efforts. Despite obstacles, we expect companies will be able to price innovative products for a sustainable return on investment because lower prices will be offset by volume.

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