The Challenge
Ensuring the timely and accurate submission of ICSRs allows pharmaceutical companies to showcase their dedication to pharmacovigilance and meet regulatory standards. Furthermore, exchanging ICSRs with License Partners aids these companies in tracking their drug safety profiles, assessing risk vs. benefit through Safety Signals, and formulating risk management and minimization strategies. However, a range of challenges must be addressed before companies can effectively leverage ICSR Submission/Exchange.
Complex Regulatory Requirements: ICSRs must adhere to the constantly evolving stringent regulatory standards set by Health Authorities such as the EMA, FDA, Health Canada, PMDA, MHRA, MFDA, CFDA, and TGA.
Quality Issues: Manual submissions can severely compromise the quality and accuracy of ICSR submissions, potentially leading to regulatory discrepancies and instances of non-compliance.
Time Consuming: When MAH receives cases in the ICSR format from Health Authorities like the MHRA or license partners, and there is no gateway system in place, the process becomes notably cumbersome and lengthy. A common procedure followed by many companies is:
- ICSRs are emailed (as attachments) to designated mailboxes or individual email addresses.
- A responsible team oversees this mailbox. Upon receipt of an email, the ICSR is extracted, and the email is archived.
- The extracted ICSR is then forwarded to the Safety System as E2B R3 files.
UltraGATE Benefits
- Ensures accurate and timely ICSR reporting.
- Reduces resource expenditure (both in terms of personnel and finances) by 70-80% for the submission team.
- Facilitates swift onboarding with pre-established and validated strategies that comply with most Health Authorities.
