When it comes to pharmaceuticals, navigating the post-approval landscape is crucial for market success and compliance. Here’s a concise comparison of regulatory requirements between the US and EU across various change categories.
Specification Changes:
- Relaxing acceptance criteria: US (PAS) vs. EU (Type II)
- Deleting part of a specification: US (PAS) vs. EU (Type II)
- Addition of new test and limits: US (CBE-0) vs. EU (Type II)
Container Closure System Changes:
- Polymer changes in primary packaging: US (PAS) vs. EU (Type IB)
- A change in or addition or deletion of a desiccant: US (Ann. report) vs. EU (Type IA)
- Sterility assurance impacts: US (PAS) vs. EU (Type II)
Labelling Changes:
- New indications and usage: US (PAS) vs. EU (Type II)
- Clinical study section updates: US (PAS) vs. EU (Type IB)
- Claims of superiority to another drug product: US (PAS) vs. EU (Type II)
Miscellaneous Changes:
- Stability protocol addition: US (PAS) vs. EU (Type II)
- Expiration dating period extension: US (Ann. report) vs. EU (Type IB)
- Any change in the process, process parameters, and/or equipment: US (PAS) vs. EU (Type II)
Manufacturing Process Changes:
- Controlled release characteristics: US (PAS) vs. EU (Type II)
- Sterility assurance impacts: US (PAS) vs. EU (Type II)
Manufacturing Site Changes:
- A move to a different manufacturing site for the manufacture or processing of any drug product, in-process material, or drug substance: US (CBE-30) vs. EU (Type IB)
- A move to a different manufacturing site for secondary packaging or labeling: US (Ann. report) vs. EU (Type IA)
Understanding these distinctions ensures smooth regulatory navigation and global compliance. For more details, refer to the attached PDF. If any discrepancies are found, please let us know!
Read also:
- Differences in Filing for Drug Master File in US, Canada and Europe
- Contents of Marketing Authorization Dossier
