Current Landscape in Regulatory Submissions
This article is a summary of a presentation by Leslie Kowitz, MA, ELS, and Chris Small, MA, ELS, at the 2024 Pacific Coast Conference.
With the advancement of scientific knowledge and technology, we are able to reveal the mechanisms or pathogenesis of diseases that were mysterious to us in the past. Our continuous work on searching for safe and effective treatments is a promise to curing diseases. As a result, small biotechnology and large pharmaceutical companies design more innovative clinical studies and establish advanced manufacturing processes to facilitate drug discovery. On the other hand, medical writers, as a piece of puzzle in the drug development landscape, are given fewer flexible deadlines to author long and complex regulatory documents.
Leslie Kowitz and Chris Small have extensive experiences on editing CMC regulatory documents. They point out a rising expectation of increasing efficiency in medical writing. Given a tight project’s turnaround time, project planning and developing checklists to prioritize tasks become crucial to allocate resources appropriately. Lean writing is one of the key skills that have been broadly advocated in regulatory medical writing. Medical writers need to familiarize themselves with lean authoring to produce work concisely and reduce ambiguity. Additionally, more tools are available to enhance efficiency. Companies should consider adopting these new technologies into training programs to stay on with competitors. Internal tools such as format templates or guidelines should also be developed and internally implemented.
Furthermore, when a document is submitted to the Agency, medical writers need to ensure the information is aligned with regulatory requirements. If the document is sent out to multiple regulatory agencies for review, medical writers should understand the current guideline to provide correct contents. One example is the ICH Q12 Guideline, Technical and Regulatory Consideration for Pharmaceutical Product Lifecycle Management, which is a harmonized guideline to facilitate the management of any post-approval CMC changes.
In the near future, medical writers will face more challenges in the workplace. We need to continue growing our skills and applying knowledge to turn challenges into opportunities.
About the author: Linhui Li, PhD, is an associate medical writer in regulatory at Pliant Therapeutics. She earned her PhD in pharmacology and toxicology from UC Davis and BS in biochemistry from UC Riverside.
