China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are helping multinational drug makers tap into the Chinese pharmaceutical market. Synchrogenix’s China Service Line has compiled a list of seven things to know about the China pharmaceutical industry to help your understanding.
1. CFDA Name Change
China Food and Drug Administration (CFDA) has officially changed its English name to National Medical Product Administration (NMPA). NMPA now falls under the State Administration for Market Regulation (SAMR), a newly established agency at the ministry level, and no longer reports directly to the State Council. The Center for Drug Evaluation (CDE) under NMPA remains without change in function.
2. Important NMPA Announcements
NMPA recently issued two important announcements:
- Updated IND procedures/guidelines and updated GCP guidelines that every company should know before filing an IND with NMPA’s CDE or carrying out clinical trials in China
- 48 foreign-made drugs for urgent unmet medical needs have been listed for public review. These drugs have been approved outside of China but not yet in China. As a result, these drugs can now be approved for registration without clinical trials being conducted in China (the applications must show data consistent in safety and efficacy across races and ethnicities), which will raise potential competition for domestic pharmaceutical companies.
3. Imported Drugs
China’s new policy allows the import of new drugs from abroad more quickly, and at significantly reduced prices. For example, the price of new PD-1/PD-L1 drugs (Opdivo and Keytruda) entering China has been as low as a quarter of their costs in the United States. Seventeen cancer drugs recently entered the Chinese health insurance system and their cost has been covered by the government by greater than 50% on average. Based on these policy changes, most of the windows for Chinese pharma companies to use drug license-in to bring late-stage drug candidates have basically been closed.
4. Generic Drug Approvals
The model for generic drug approval shows that, in general, no more than three pharmaceutical companies can afford a full competition. Approximately 70% of the market sales will be granted to the first bidder who won the bid for a generic drug and the remaining 30% for others. It is expected that more generic drug makers will close throughout 2019.
5. Double Registration Filing
For most Chinese R&D pharmaceutical companies, double registration filing (FDA or EMA first, then China) still offers advantages in terms of approval speed/time and filing cost, due to special policies issued by former CFDA. Many companies have recently opened U.S. branches to speed up their filing.
The new patterns in drug R&D sectors in China is completely subversive, compared with before 2017. The majority of pharmaceutical companies now face a very competitive situation and are forced to develop their own original drug candidates or search for/acquire early stage candidates from abroad; however, the CROs (both clinical and non-clinical) in the industry benefit most from this change.
7. eCTD System
An electronic common technical document (eCTD) system under installment in CDE/NMPA is expected to start working and accept e-submissions during the first quarter of 2019.
The global regulatory environment continues to evolve toward increasing compliance requirements, scrutiny, and enforcement. Synchrogenix’s experts have access to the most comprehensive, accurate and reliable market and regulatory intelligence available, including:
• Global regulations
• Agency trends and new markets
• Regulatory changes and updates