Product launch of a pharmaceutical product is not the end of the complex drug development cycle, especially the labeling component. Advanced tools for analytical development and increased availability of (electronically accessible) real-world data related to clinical use, allow us to re-evaluate the effectiveness and safety of a pharmaceutical product. More specifically, new insights of indications are gained: dose regimens, limitation of use, safety information and magnitude of risk of the pharmaceutical product.
In this article several challenges are highlighted which can help the evolution towards standardization of the pharmaceutical product labeling:
- Critical findings associated with labeling compliance are most frequent reported by the Health Authorities. Labeling discrepancies are related to the following categories:
- Change to a warning of the CCDS not implemented nationally
- Information included in national labeling but not in the CCDS
- Communication of a signal/risk (labeling change)
- Minimizing a risk (Risk Management Plan Change).
- When new info becomes available this frequently, it causes the labeling to become inaccurate, false or misleading. Therefore, there must be a comprehensive strategy within each company that identifies roles and responsibilities of different stakeholders and a clear communication plan which captures meaningful and relevant content to progress the signal to the label and beyond.
- A noncompliance risk can occur as it affects ongoing operations in several ways (possible withdrawal of a drug from the market, increased scrutiny from regulators, delays to pending parked application approvals, loss of revenue).
As of today some developments towards standardizing the product labeling process are made:
- Publications of all safety signals discussed during the PRAC meeting.
- CCDS is reviewed at least annually and updated appropriately OR when a trigger event occurs. (Trigger event: safety-related update, product line extension, product quality changes, change in MAH's position on core labeling based on feedback from HA.)
At Modis we can provide you an energetic team of project managers with a lot of experience in the end-to-end labeling process, which can help to make significant movement towards the standardization of the labeling process.