Since May 2025, the scope of CDP has been expanded with the implementation of Step 2 of the Policy 0070 resumption, including:
- All new Initial Marketing Authorization Applications (no longer limited to new active substances and COVID treatments).
- Line extensions and major Type II clinical variations (extension of indications).
- Negative opinions and withdrawn applications.
- Excluding all biosimilars, hybrids, and generics.
For legacy procedures approved while the policy was suspended, publication is managed “upon request” via Access-to-Documents. Requests related to legacy clinical data will trigger a CDP procedure.
At Asphalion, we understand the challenges this presents 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 Commercially Confidential Information justifications
- Publishing and submission activities
Trust Asphalion to help you simplify and optimize your CDP processes, ensuring compliance and efficiency at every step.
Contact us at: [email protected] for further information
