Since May 2025, the CDP scope has been expanded with the implementation of Step 2 of Policy 0070 resumption to include:
- All new Initial Marketing Authorization Applications (no longer restricted to New active substances and Covid treatments)
- Line extensions and major clinical Type II variations (extension of indications)
- Including negative opinions and withdrawn applications
- Excluding all biosimilars, hybrids and generics
For legacy procedures approved while the policy was suspended, the publication is managed “upon request” (via Access-to-documents). Those requests related to legacy clinical data will trigger a CDP procedure.
At Asphalion, we understand your challenges and have the expertise to guide you through CDP – Policy 0070, offering tailored solutions with a deep understanding of the regulatory framework. Our services include:
- Liaison with Health authorities
- Definition of redaction and anonymization strategy
- Execution of anonymization and redaction processes, including Quality Check
- Preparation of Anonymization reports
- Assistance with justifications for Commercially Confidential Information
- Publishing and submission activities
Contact us! [email protected]
