The New Regulations: Will They Hurt Your Business?
By Ambrish Mathur, VP strategic development, ArisGlobal
Accurate and timely safety/ pharmacovigilance (PV) reporting is required to avoid embarrassing Warning Letters and potentially huge fines and penalties. Recently, the reporting format was revised, and the new structure, E2B(R3), has been finalized and is targeted for adoption in Europe in 2016. Also, the FDA has recently issued regulations requiring mandatory electronic reporting of ICSRs (individual case safety reports) for drugs, devices, and vaccines, effective in 2015. Marketing authorization holders (MAHs) need to start planning for these changes now or face the risk of not being in compliance when the new rules go into effect. The following are some key business issues you need to be aware of as you plan for these mandates.
Compliance to the new standard will require a significant investment in your drug safety/PV department. Your adverse event data capture, management, and submission process will need both business- and system-level changes. The need to collect and process additional data related to safety issues may require changes and training at various collection and processing points, including all your local safety offices and external partners. You also need to assess the impact of the changes on other departments that provide or process safety-related data, such as clinical-trial data management and regulatory affairs.
Another challenge concerns how your company’s products are identified in the new format. Companies now have to maintain their product master data to comply with the Identification of Medicinal Products (IDMP) standard. The IDMP is used to identify all regulated products through the product life cycle (premarket to postmarket). European regulations mandate MAHs to adopt the IDMP terminology by 2016, with the FDA and the rest of the world indicating their adoption mandate will follow soon thereafter.
While submitting ICSRs is a primary safety/PV function, maintaining product data and implementing product dictionaries such as IDMP is typically managed by your regulatory affairs function. As the IDMP terminology will be needed for the new-format ICSR creation, the two departments will need to work collaboratively to plan an appropriate level of interface.
Industry experts estimate that a complete IDMP assessment and solution implementation for a large pharma could take 12 to 21 months, depending on their current processes and data-store configuration. Research has shown that barely 20 percent of pharmaceutical companies have fully implemented a strategy for managing their information to meet the new IDMP guidelines.
While assessing how you will ensure compliance to both E2B(R3) and IDMP, each responsible department has an opportunity to improve efficiencies. You can implement these optimizations in conjunction with deploying/updating a technology solution, providing added business value from the projects, and maximizing use of already planned budget expenditures.
On the data center/IT front, this may be a good opportunity to assess any system upgrades, integrations, or replacements you may have been putting off (e.g., transition to SaaS and/or cloud-based computing).
The linkage between the submission and product identification standards offers that final justification to include a shared repository of product information in your budget. For your regulatory affairs function, this is your opportunity to affect those product master data management strategies that may have been on the back burner.
The challenges in reaching compliance with the new requirements should not be underestimated, and you need to start developing a clear action plan across business lines and regions now if you want the best ROI.
Begin by appointing a planning and oversight committee spanning safety/ PV, regulatory affairs, and IT to ensure appropriate collaboration and harmonization across projects. If applicable, a phased approach that addresses the FDA medical device and vaccines electronic reporting requirements in 2015 can provide an interim step, leading to the 2016 readiness for IDMP and for drug ICSR reporting using the new format.
Perhaps this is the ideal time to explore and introduce global operational efficiencies while implementing these new compliant solutions. This is the time to rethink — and perhaps further optimize — your affected business processes and ensure this is a strategic business effort, not just regulation-mandated new resource investment and IT spending.