Other
notable changes include more situations where alternative options cannot be
addressed using a single CEP application and would require a separate CEP
application. Examples of where a new separate CEP application is required
include alternative substantially different routes of synthesis (even when the
impurity profile of the final substance is equivalent) or multiple
manufacturing sites for the final substance which do not belong to the same
group, or use of a material from more than one source where the TSE risk is
different for the different sources.
Applicants
are strongly encouraged to read the revised guideline as some of the changes
may impact their regulatory strategy for CEP applications they intend to submit
during 2019.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
No comments:
Post a comment
Pharmaceutical Microbiology Resources