Around the world, the eCTD is becoming the mandated submission format for drug applications as the move away from paper is environmentally important and facilitates the submission review for both health authorities and sponsors. FDA, EMA, Health Canada, PMDA, CFDA (adoption).
Our expertise lies in:
EMA require public disclosure on the EMA website of clinical data from Marketing Authorisation Applications submitted after January 1st 2015 (Policy 70), including EPARs, variations, and referenced data previously submitted. These documents must be anonymised to prevent disclosure of patient’s protected personal data (PPD), and the Sponsor can request redaction of any commercially confidential information (CCI).
RApport can support your redaction requirements by:
Providing guidance on the policy and its implications.
Support the development of your redaction strategy.
Drafting the Justification Table for CCI proposed redactions, and the PPD Anonymisation Report describing actions taken and residual risk.
Conducting the redaction of the clinical package.
Supporting your interactions with the EMA.