- CCRs reporting and risk assessment :
For new changes impacting licenses registered in China, it is needed to evaluate the reporting level of the change in China as well as to make a risk assessment versus the local regulations/context => Need to work in interactions with the regCMC global team and the RA local team to perform both the Reporting level and Risk assessments at the same time.
In the frame of the global Licence Conformance exercise, the complete list of Cat 3 gaps for Imovax Polio and Act-Hib is available => Make the risk assessment for each cat. 3 gaps
- Regulatory intelligence :
Several new guidelines are expected to be released soon => Need to review them and evaluate the potential impacts
- Writing of CMC China specific dossiers and maintenance of document inventories:
In some cases, a specific CTD dossier is needed for China in order to take into account specific data that would be needed to support the change or reformulate the information to make them more acceptable by CDE… => Write the Chinese specific CMC dossiers based on the dossiers submitted in the CoO and information provided by the PFPs.
Some doc inventories are available for all product registered and marketed in China in order to be able to know at any time the reference of the documents registered in China and of the ones under evaluation. They also track and highlight the sections that are specific to China => Keep those doc inventories up-to-date