The Big Picture in Safety, Part 1 of 4: Compliance Isn’t New in Life Sciences. Or Is It? Managing Safety in a Rapidly Changing Regulatory Environment
Oct 04, 2016
Pharmacovigilance plays a critical role across the business, and an increased focus on safety in a global context means companies need to think about their approach to pharmacovigilance management systems across four key pillars: regulatory compliance, productivity, quality management, and total cost of ownership. This four-part series takes a closer look at the importance and opportunities in each of those critical and interdependent areas.
The life sciences industry faces an increasingly stringent set of compliance regulations and requirements pertaining to pharmacovigilance across the United States, Europe, and Japan. Are these requirements that are coming faster, from more sources, having a greater impact on a company’s systems and processes? Are they driving up cost where the budgets don’t have the wiggle room to absorb it?
How can companies gain the agility they need to comply without massive systems’ overhaul efforts?
There is a clear move toward electronic submission of individual case safety reports as regulators recognize the importance of accelerating the exchange of safety information.
From November 2017, the European Medicines Agency (EMA) will require marketing authorization holders (MAHs) to submit electronic individual case safety reports (ICSRs) of suspected adverse events to the EudraVigilance database in the E2B(R3) format for regulatory reporting. The US Food and Drug Administration (FDA) similarly will be requiring companies to report in the E2B (3R) format as of the third quarter 2018. While not yet a mandatory requirement, as of April 2016, Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) began accepting E2B(R3) formatted files.
On a much wider scale, Identification of Medicinal Products (IDMP) regulatory initiatives are ramping up, with finalization expected from early- to mid-2017.
Having a comprehensive platform that is able to meet current requirements and that can anticipate and navigate the regulatory changes ahead will be critical for life sciences companies. All too often, companies lack a broad overview of their critical safety data because information is kept in multiple and disparate databases — including from global affiliates — without the benefit and efficiency of a common repository.
Furthermore, companies can’t simply rely on safety cases that are reported to them, but rather need to assess additional data – through literature searches and even from social media sources – meaning companies need a solution that can help them address domestic and global pharmacovigilance, clinical safety and risk management programs.
The risk of losing key insights from important safety data, including from non-ICSR sources, could have potentially severe regulatory implications. In many markets – including the United States, Europe and Japan – these could include citation and sanctioning resulting in heavy fines and suspension of marketing authorization. Sometimes, it has even led to withdrawal or recall of a product, dealing a huge blow to the company’s reputation and bottom line.
Life sciences companies need to take a more holistic approach to their solutions and processes for regulatory compliance pertaining to pharmacovigilance.
Contact ArisGlobal to learn about the recently launched TotalSafety 7.3, an innovative upgrade featuring technical and usability enhancements to the company’s leanest and fastest integrated suite of safety products.