Recently, China’s NMPA has started to implement more programs for drug safety. Drug supervision has increased, and the number of crackdowns has jumped dramatically. Last year, there were about 160,000 regulatory investigations of false drug claims, inoperative medical devices, and other problematic issues. This is a significant increase over 2021. China regulators will crack down on poorly run online drug sellers, high-risk drugs, supply chains that do not use the 2-invoice system, purchasing organizations, etc.
In addition, penalties for companies and individuals with these problems will face harsher penalties including stricter penalties, the possibility of shutdowns, and jail time. Personal penalties will also be levied. Increased NMPA surveillance will hopefully lead to a better drug business in China.
Besides the China crackdowns mentioned above, the US Justice Department has also recently cracked down on 4 China drug manufacturers and 8 Chinese individuals who were making the forerunner products for Fentanyl. Last month, Chinese companies and individuals were indicted.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.