BOSTON, MA --(Marketwired - February 16, 2016) - Pharmaceutical labeling is a constantly evolving and complex discipline for all labeling professionals. Not only are there emerging new regulations that pharmaceutical and generic pharmaceutical companies need to comply with, but when submitting their labels to FDA or EMA there are always different items to document per regulation they are adhering to. Labeling professionals are constantly working to coordinate a more robust End-to-End Labeling process while adhering to new guidances such as the Pregnancy & Lactation Labeling Rule (PLLR) and new guidances with submitting Combination Product labeling.
Gerrit Nijveldt, Senior Director, Regulatory Affairs -- Labeling at Sanofi, recently spoke with marcus evans regarding the differences in regional and local labeling requirements that may have an impact in the development process of the drug and label:
How does the labeling review process differ in the US and EU? Are there any similarities?
GN: There are lot of differences and similarities when reviewing a label in the US and EU. The main difference is due to how the dossier is reviewed from a regulatory perspective. FDA performs their own data analysis and this can lead to surprising labeling statements. Both have detailed regulations and guidances that need to be followed in order to develop the label.
Another difference is the timing. In the EU, there are set milestones where you get labeling comments and you know when that happens. In the US, the main comments on labeling will be closer to the PDUFA date of the submission.
How does using a Development Core Data sheet affect the value and clinical development process?
GN: Labeling is finalized at the end of the line of the development process as it is one of the last documents that goes in the dossier. But when developing the drug, you have to think during this process with the end in mind, i.e. the label. You need to know early on what and how the company would like to present the data in the label and that will determine how to do your clinical program -- of course in consultation with agencies. It is important to determine in the early stage of development what you want to state in the label and what data is needed to support that.
When developing a Target Product Profile (TPP) that meets FDA requirements, how do you know how much information is enough? Are there any challenges when developing a TPP? How do you overcome these?
GN: The TPP develops over time and more information will be added. However, some information cannot be added because you need the final data in order to do so and you will only have that data close to or at submission time. What the company feels comfortable to share with the FDA is different per company. However, if you have a specific question regarding the PI, you need to add the labeling text. The question related to labeling needs to be specific with what you are asking and it should not be answered by FDA with just a simple "Yes/No/we will see." Asking the agencies if the studies will support the label will result in the answer that it will be a review issue.
Join Gerrit at the 4
View the conference agenda to see who will be joining Gerrit on our speaker panel.
About marcus evans
marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decision-makers. Our global reach is utilized to attract over 30,000 speakers annually, ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines.
For more information, please contact
Tyler Kelch
Digital Marketing Manager, marcus evans
312.894.6310
Tylerke@marcusevansch.com
