One big change the regulations introduce is to the relationship between manufacturers and NBs. Right now, NBs are more of an industry partner in helping manufacturers getting through the submissions process. That role is changing to more of an end-to-end product/process regulatory agent and an extension of the CA market surveillance.
As for what to expect, we know that vigilance and post-market complaints will continue to be one of the main sources of review, a leading metric of overall QMS effectiveness.
There are also changes to reporting timelines and electronic reporting. Manufacturers need to review their PMS procedures to make sure they clearly establish responsibility for providing this additional data and support. Manufacturers need to create procedures to deal with these requirements if they haven’t already, and of course always be prepared for an audit.
