International Pharma Organisations Risk Products Being Withdrawn from Market due to Poor Post-Approval Commitment Planning & Tracking
ISI solution helps life sciences companies close the loop on regulatory submissions management, making it easier to track and meet post-approval marketing commitments
Eschborn, Germany – October 5, 2010- A vital stage in the regulatory information management process is tripping up pharmaceutical organisations with potentially serious results, as a high-profile case in the US has recently shown.
Although most life sciences organisations have stringent practices in place to ensure meticulous attention to detail when submitting regulatory drug applications or amendments for approval, many have found it more difficult to track and deliver against their post-approval regulatory commitments because of the complex administration involved. Yet this is something that the health authorities, including the FDA in the US, are now taking steps to correct, potentially resulting in product licences being rescinded and products withdrawn from the market.
“Regulatory commitment management and planning are key to any regulatory affairs team to ensure their products stay on the market,” comments Adam Sherlock, European MD at ISI Europe, which specialises in the provision of regulatory information management tools and services to the international life sciences industry. “The trouble is, there is so much complexity and work involved in getting a product through the approvals process that it has been too easy to lose sight of commitments made during the application process - and which were a condition of the approval being granted.”
Such pledges may involve a commitment to provide ongoing, updated information and data, or to develop studies and white papers. “Meeting these commitments can be as complex and involved as the regulatory application process itself,” Adam notes. “It involves the input of often diverse, dispersed team members, gathering and providing particular information at specific times. Many project teams disband after approval, too, with the result that much of the responsibility for follow-up falls to regulatory affairs, even when the commitment is for a new clinical trial. The lack of a tracking system to help monitor the commitments made, and ensure that these are met, is a risk, particularly when it comes to health authority inspections and audits.
“Compared with the application process, which has been boosted by the need to embrace electronic submissions, post-approval commitment tracking and planning has been neglected in terms of formal structure and discipline. The good news is that this needn’t be the case, as tools exist to promote, manage and accelerate this process, just as they do for managing and tracking the original application publishing and submission process.”
ISI, which offers a comprehensive range of software solutions and services to help pharma organisations navigate the licence applications publishing and submission process, ensuring complete compliance with national and international format requirements, also provides a robust suite of regulatory information management applications that drive, track and manage post-approval commitments.
“Completing the cycle is vital in maintaining a company’s revenues, by ensuring that products are fully compliant at all times and remain on the market for as long as possible,” Adam concludes. “This is particularly the case today, as there are fewer blockbuster drugs and fewer NCEs, which means that companies need to make the most of their product portfolios. Geographical expansion is also common, meaning companies have even more commitments to monitor and adhere to.
“Not only can our tracking tool be used for notifications of when a commitment is due, but the data in the system could also be used to determine what types of commitments are regularly being made. In this way it enables continuous improvement, for example by ensuring in future that the same types of studies or requests from the health authority are in a more robust original application dossier and not reserved for follow-up actions.”
To find out more about ISI and its regulatory solutions, go to http://www.imagesolutions.com/solutions.html