The rapid development of China’s pharmaceutical market has attracted the attention of many international health–tech companies. China has a huge patient population, with a heavy disease burden especially in chronic and severe diseases. However, for most international companies, lack of understanding of China’s regulatory approval process has been a major obstacle to enter the Chinese market. The regulatory process is considered as complicated and time-consuming, involving strict requirements and many regional specific documents. In recent years, the regulatory reforms implemented by NMPA have streamlined the approval process for innovative drugs and medical devices, making it easier for international companies to enter the Chinese market. This has opened up a plethora of opportunities for health-tech companies to collaborate with local partners, conduct clinical trials, and introduce their cutting-edge technologies to address the healthcare needs of the Chinese patients. Here are the common questions that are being discussed recently.
Q1: China’s drug regulatory agency, NMPA(National Medical Products Administration), has undergone significant reforms over the past few years. What direct impact does this have for drug developers and industry?
A: These reforms have been implemented to support the development of innovative drugs and to ensure patient safety. The changes include establishment of a more comprehensive regulatory framework, a transparent drug registration process, and clear timelines for drug developers and sponsors. As a result, the drug industry in China has become more competitive and has attracted increased investment from both domestic and international stakeholders.
Q2: Now China is now a member country of the ICH, does it mean that product developed under ICH guidelines by companies outside of China can be accepted for registration by NMPA?
A: Joining ICH means China now aligns its drug development practices with international standards. Use of overseas clinical data to support drug registration in China becomes feasible, allowing for simultaneous global development of medicines. Furthermore, NMPA’s adherence to ICH technical guidelines for drug registration brings its requirements for non-clinical, clinical, and CMC closer to those of the FDA and EMA. However, it is important to note that alongside the ICH guidelines, the NMPA has also issued additional guidance documents in different areas. It is crucial to assess the gap when planning the development or registration strategy for China.
Q3: Are there any practical suggestions to speed up innovative product development in China?
A: In today’s ever consistent global regulatory framework, including China in the global synchronous development of drugs is the most efficient and beneficial choice.
Under the current Chinese regulatory framework, clinical trial application will be implied approval with 60 workings day timeline, making it possible to include the Chinese population in MRCT to avoid additional bridging and confirmatory clinical trials repeated in China.
Similar to FDA and EMA, NMPA now provides expedited pathways including Breakthrough Therapy Designation, Conditional Approval, Priority Review etc, all of which are designed to accelerate the development and marketing of innovative drugs with unmet medical needs.
Q4: Any suggestions for those products already marketed in the EU or the US market to enter China quickly?
A: For rare disease therapy and pediatric medicine, NMPA now offers regulatory flexibility over the Chinese patient data and short review timeline for market authorization application, and such practice will enable a faster excess to patient and market. In addition, there are special access programs implemented in the Hainan province and Greater Bay Area for product with urgent clinical needs. Such programs will allow products not registered in China but approved by FDA/EMA/PMDA to be used in these regions first, NMPA also encourages using the Chinese patient data from real world studies in these regions under specially access program to support the market authoriztion with NMPA later. The approval of such special access program is delegated at the provical medical product agency, greatly shorten the first launch time.
Published on: Jan 9, 2024