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)
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.