As a medical writing services provider that works with clients in varying stages of their document preparation, we come across a range of obstacles with CCDS projects. One main challenge is the lack of expertise from even the most seasoned and well-versed medical writers. Often, they are more familiar with the previously acceptable and less stringent labeling regulations.
Below are the most common reasons why Pharmaceutical companies rely on third-party CCDS Support:
- General lack of expertise and scarce internal resources
- Difficulties with document gathering and organization
- Comprehension of the literature search process
- Internal process is too inefficient for continued compliance
The overall efforts required to create or update CCDS documents in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) can vary greatly due to the current regulatory situation of the company. Members of Regulatory Affairs teams often are not familiar enough with their own portfolio to be able to write a comprehensive and compliant CCDS internally.
There are generally two triggers that lead to pharmaceutical companies updating their CCDS. The first is due to a regulatory labelling recommendation or mandate from the health authorities. While the effort required to remediate the labelling discrepancies can vary, there are certain steps your safety team must take to account for the possible CCDS implications of the recommendation. While a labelling mandate is straightforward and requires all companies to adjust the labelling of their product, it may not necessitate an update to the CCDS. After a health authority recommendation or mandate, your internal safety team must evaluate whether the internal CCDS should be updated.
The second most common way a CCDS update is set into motion stems from the internal review system from a manufacturer’s pharmacovigilance team. Most teams run systematic literature and case reviews of adverse drug reactions at a varying cadence with the goal of identifying any safety concerns. If the internal team believes there is a safety concern, then the CCDS will be updated first, followed by updates to the product’s labelling.