How the NMPA is Changing
the Chinese Pharmaceutical Industry
China is currently recognized as the world second largest pharmaceutical market. However, the regulatory policies have been very challenging for many large foreign pharmaceutical enterprises, as well as innovative local companies. Some of the reasons for those challenges are:
- Complicated and long review processes compared to most major countries.
- Limited clinical trial quality checks with no enforcement mechanism, which caused issues when compared with international standards.
- Lack of people in regulatory bodies which caused a 20000+ backlog and long queue time for approval.