China – a Tale of Confusion

 

The Chinese model is far more stringent than other regulations. Companies are required to:

  • obtain their serial numbers directly from the Chinese authorities
  • report on their use (there are restrictions on how data must be uploaded and presented)
  • aggregate

However, the Chinese regulation was put on hold in February 2016. There have been various announcements as to the availability of a new, revised regulation and new guidelines have been published for discussion. However, no official replacement regulation has been published and the situation is far from clear.

The CFDA is still issuing serial numbers for use, although there is no official guidance on how to obtain serial numbers for newly registered drugs.

Get in touch with us

Contact us
Contact Us

This website uses cookies to give you a more comfortable browsing experience.

The use of cookies is described in our cookie policy.