This blog covers the following topics:
- Regulatory submission guidelines
- A brief checklist for regulatory requirements
- Key takeaways and insights
Table of Contents
Introduction
Today, almost every product we use is subject to regulatory oversight, not limited to medicines. Regulatory duties involve monitoring, market availability and ensuring its safety.
When it comes to pharmaceutical products, the regulations are even more stringent due to their direct impact on public health.
Each drug governed by specific rules, and monitoring activities are bound by strict timelines.
In this blog, we focuses on what cases needed the regulatory submission. In specific for pharmacovigilance case submissions. Let’s dive in!
✍️ Note: This article does not cover the specific list of timelines to follow.
Essential Steps to Consider: A Practical Checklist
Regulatory submission of cases often surrounded by uncertainties, especially which scenarios to follow.
This includes instances like follow-ups, downgrading events and handling cases from the Marketing Authorization Holder (MAH). Having a well-defined checklist can help eliminate confusion and streamline the case processing.
Here’s a helpful checklist to guide you through the process:
- Cases from MAH: Ensure you identify and categorize cases originating from the MAH.
- Agreement Type with MAH: Review the type of agreement in place with the MAH.
- Receipt Dates: Confirm the dates when the cases were received.
- Centralized Processing: Check when the case was received centrally for processing.
- Valid ICSRs: Verify the validity of Individual Case Safety Reports (ICSRs).
- Literature Case Processing: Ensure proper handling and processing of literature cases.
- Follow-up Classification: Determine if the follow-up is significant or non-significant.
This checklist can greatly reduce confusion and ensure smooth regulatory submissions.
“Thanks to our progress and regulatory submissions, we’re ahead of the game; without them, our future would be at risk.”
Conventions in Regulatory Submissions
- Valid ICSRs Only: Only valid Individual Case Safety Reports (ICSRs) require regulatory submission. The submission timeline for a valid ICSR begins once information containing the minimum criteria has been brought to attention.
(“EU Individual Case Safety Report (ICSR)1 Implementation Guide,” n.d., p. 21). - Submission Timelines: Timelines for submission calculated in calendar days, starting from day zero.
(“EU Individual Case Safety Report (ICSR)1 Implementation Guide,” n.d., p. 21). - Reporting Adverse Events: Adverse events, including lack of efficacy and medication errors, must be reported to NCC-PvPI, IPC, or the National Regulatory Authority. (CDSCO, p. 22).
- Compliance with Submission Timelines: Ensure that the Marketing Authorization Holder (MAH) can comply with the submission of valid ICSRs within the specified timelines. (“EU Individual Case Safety Report (ICSR)1 Implementation Guide,” n.d., p. 21).
- Medical Literature Reporting: For ICSRs derived from medical literature, the clock starts (day zero) once awareness of a publication containing the minimum criteria is obtained. (“EU Individual Case Safety Report (ICSR)1 Implementation Guide,” n.d., p. 21).
- MAH Agreements Matter: Agreements with the MAH play a crucial role in determining whether they comply with regulatory timelines for submission.
- Calendar Days Calculation: Calendar days counted from the initial receipt of information by the national or regional pharmacovigilance center, the competent authority, or any personnel of the MAH, including medical representatives and contractors.
- Follow-Up Information: When additional significant information is received for a previously submitted case, the clock for submitting a follow-up report restarts from the date the follow-up information is received.
- Serious to Non-Serious Cases: If a case originally classified as serious becomes non-serious based on new follow-up information, it must still be submitted as an expedited report. The submission time-frame for non-serious cases applies to subsequent follow-ups.
- Nullification or Merging of Cases: If cases are nullified or merged, they require re-submission, even if submitted already.
- Amendments or Significant Information: In cases where new significant information emerges, either through internal review or corrections, re-submission is necessary, accompanied by a follow-up receipt.
Key Takeaways
Only valid ICSRs should be submitted for regulatory purposes in ICSR management.
The first downgrade of serious events requires expedited submission.
Only significant information should be submitted during follow-up reports.
All nullifications and case mergers require regulatory submission.
Every MAH report should be carefully reviewed for compliance with submission agreements.
Concerned about meeting regulatory timelines?
Don’t worry – reach out to Drugvigil for solutions and learn about the services we offer.
Don’t wait any longer – send us an email or give us a call today!”
Conclusion
This comprehensive article aims to provide clarity on conventions that have often caused confusion, particularly for beginners in the field.
If you found this article helpful and informative, please consider sharing it with your colleagues and friends to spread the knowledge.
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