Understanding the differences in China’s Regulatory market:


In this article, you will find a succint overview of 4 different strategies that pharmaceutical companies can apply if they are pursuing the approval of their drug product in China. 

Although this emerging market is seemingly a great source for increased revenues, it does beg to question if the regulatory hurdles are worth the investment. So, to answer you should have a look at the various pathways.

Thanks to being a rapidly emerging market and the world’s fastest growing pharmaceutical industry China’s market is estimated to reach $175B by 2022. And, ever since China has joined the ICH the regulatory landscape has been under scrutiny and improvements have been made to promote the structural adjustment and technological innovation of the drug and medical device industries, to enhance these industries’ competitiveness, and to meet the clinical demand of the public.

Some of the highlights to mention are the reform of the Administration of Clinical Trials, Accelerated Marketing Review and Approval timelines, improved technical support capacity, and an overall strengthened organization of the drug regsitration process. And above all, overseas clinical data is now also accepted to support your clinical development.

Despite its rapidly evolving life sciences industry it is still a very unique market with many characteristics that requires the adoption of specific clinical development and market access strategies compared to other major markets.

Who is the CFDA?

In China, drug and biological products are regulated by the CFDA, which is a counterpart of the US FDA. The Center for Drug Evaluation regulates both drug and biological products in the country.

What is the usual Market Authorization process in China?

Marketing authorization of a new drug in China mandates that clinical trials with Chinese patients are performed to ensure safety regarding ethnicity issues. In the regular pathway, an applicant has to conduct a phase I PK trial together with randomized trial which should include at least 100 pairs. It should be kept in mind that the overall clinical trial application review and approval process takes about 12 months.

Drug importation?

Drug import approval mandates the availability of a marketing authorization located outside of China and multi-region clinical trials can be started only after the new chemical entity has passed a phase II trial outside of China. This actually prevents China from participating in global trials and the possibility to develop drug simultaneous with overseas countries in some cases.

How is overseas clinical data evaluated in China?

Following the ICH (E5) guideline for ethnic influencing factors, the consistency of the Chinese subgroup with the overall population is analyzed to ensure safe extrapolation of overseas clinical evidence to Chinese patients. It is evaluated for:

  • Data Authenticity: The data of oversea clinical trials are true and reliable, in line with ICH GCP and Drug registration requirements.

  • Efficacy and safety: Overseas clinical data support the effectiveness and safety evaluation of target indications;

  • Ethnicity: No ethnic sensitivity factors that affect effectiveness and safety.


Drug approval in China follows first international new drug application approval

From a high-level perspective we can argue that here are two main drug registration pathways in China:

  • a new drug application

  • an import drug license

For each of these two pathways, two clinical development strategies can be applied where the big difference is that there is either sequential and parallel development of the drug product. Which brings us to the different strategies that can be applied to bring a drug product to the market in China.

For Innovative New Drugs seeking approval in China:

Strategy I: Potential Strategy for imported drugs: Global MRCT that includes China + NDA Path

All for class 1 in China, worldwide new drug (not approved anywhere) 

Organise a MRCT including China Early development Phase I/II can be done anywhere. Phase III studies should include data from China but there is no designated number of people from China. Also, a PK study should be performed. If you can guarantee that there are no ethnicity differences (on case by case basis) then the trial can be executed parallel to the Phase III.

Strategy II: Potential Strategy for importing an IND: Organizing a China-standalone trial + NDA Path

In this case, the company starts from the beginning with a stand-alone trial in China. The major benefit of this approach is the lessened complication but it does require more patients to be included and thus is more constly and time-consuming.

For drugs thast are already approved overseas (class 5.1)

Strategy III: Regular path Class 5.1 Drugs

This strategy is suitable for all Class 5.1 chemical drugs which have been approved in Europe and/or USA for many years and the process is fairly standard in the sense that you apply for a CTA in to get approval to perform  a Phase I and  Phase III in China that serve as confirmative trials (these are realatively smaller in size). The Phsase III + PK studies can be performed in parallel usually unless FDA ethnicity is questioned (which is actually uncommon).

Please note that this strategy differs for drugs treating rare or life-threatening diseases which are already approved overseas and when applicants can conclude and provide the evidence hat there are no ethnic differences.

Strategy IV: Clinical trial waiver in China – directly apply for NDA

Finally, there is also the possibility of applying for a waiver for an independent local Phase III clinical trial. In this case, the China subgroup results (> 100 pairs of Chinese patients in an MRCT study) need to show consistancy with the overall global results. The applicant needs to submit the overseas clinical data in order to apply directly for an NDA in China with the commitment to perform Post-marketing studies to evaluate further efficacy and safety data. If this is not the case, an independent Phase III clinical trial, performed locally in China, needs to be performed.

Blog by Tigermed Group

Source: https://tigermedgrp.com/blog-4-ways-to-seek-approval-for-your-drug-product-in-china/