Changing submission requirements come thick and fast for life sciences companies, putting regulatory departments under continuous pressure to stay one step ahead. There are a number of issues such departments will have to tackle now and in the future — from new electronic Common Technical Document (eCTD) requirements to the adoption of new standards.
By John Verrone, Global Head, Regulatory Publishing and Quality Control, CSC
During the Regulatory Submissions, Information and Document Management Forum, held in Bethesda, Maryland, from February 6 to 8, pharma companies, regulatory authorities and vendors shared their knowledge and experience on several important regulatory submission topics. With so many sessions worth attending, I decided to focus my attention on eCTD-related issues, in particular new requirements relating to the submission of advertising and promotional materials and, in the longer term, developments concerning Regulated Product Submission (RPS), otherwise known as eCTD 4.0.
Be eCTD Ready
The requirement to submit advertising and promotional materials in the eCTD format is fast approaching. Since the U.S. Food and Drug Administration (FDA) issued its guidance in April 2015, the industry has been encouraged to move to the electronic format. As my colleague Karen Stith discussed in her blog, many companies were reluctant to move forward, uncertain how the change would affect them. However, as of May 5, 2017, implementation will become mandatory.
During an Ad/Promo session at the recent Drug Information Association (DIA) meeting, presenters discussed some important factors that companies must take into consideration as they prepare for the ad promo requirements. The first point is to allow time for setup and review of the guidance. New sections in Module 1 and specific variables required in Form 2253 are important to understand, especially when the changes are new for companies.
Speakers also raised the issue of metadata. New submission-level metadata has both fixed and variable fields, and it’s important to understand and have a strategy to avoid validation errors.
While the move to eCTD may seem daunting, greater granularity will let companies manage their promotional materials better in the long run.
The FDA will start piloting eCTD version 4, based on the Health Level 7 (HL7) RPS standard, at the end of next year and expects to accept submissions by 2019. Health Canada is on the same schedule as the FDA, and Japan will pilot in the second half of 2019 and possibly accept submissions in the second quarter of 2020. The European Medicines Agency (EMA) as yet has no schedule. The agency is hampered by lack of a central repository and by ongoing identification of medicinal products (IDMP) efforts limiting its resources.
One of the distinct advantages of RPS is that it will simplify document reuse across the globe. Currently, the FDA can share files across certain applications, but it requires knowing exactly where the file is stored on the agency servers. eCTD 4 will permit referring to documents just by an ID number so that they can be reused anywhere at the agency.
Other benefits of RPS highlighted during the DIA session include standardization and harmonization. The FDA initiated the creation of the standard to create a more flexible submission format that could be used across all its divisions, including medical devices, food additives, veterinary drugs and tobacco.
Another benefit that may take longer to implement is that the RPS standard permits two-way communications, so that negotiations over a label, questions about a submission, and product approval can be sent with an RPS / eCTD 4 message by the agency, permitting better content management of the agency’s response.
As these and other submission developments continue, companies will need to make sure they are properly prepared. This means ensuring that groups beyond the regulatory department are educated about the requirements. The problem is that all too often teams outside of the publishing groups are unfamiliar with the steps required to ensure a quality and error-free submission to the agency.
The type of training or education required will depend on the function. Clearly, regulatory managers require detailed project plans, and their teams need a microlevel understanding of the requirements. Directors, vice presidents and other higher-level executives need a brief, to-the-point overview of the process.
Style guides are another important consideration. Documents need to be consistent and clear across regions, and proper training on how to use the guides is required, including for national and regional teams. For example, is a bracket the same as a parenthesis for your offshore teams? Do they refer to it as a dash or a hyphen, and do they remember what the pound sign meant before becoming known as a hash tag?
Late in the submission process, timelines are tight and publishers must make Herculean efforts to meet demands. If other teams are properly educated and involved in the process, and if milestone points are identified along the way, a smooth and successful project is a far more likely outcome.
Learn more about Business Process Services (BPS) and how good partnership can ease many of the regulatory submission burdens by downloading CSC’s white paper, Regulatory Business Process Services: A Strategic Enabler.