|The pharma industry is bracing for
big changes in the regulatory landscape
this year. Are you ready?
The pharmaceutical industry has realized steady worldwide revenue growth over the past 15 years, but there is an array of impending technological, regulatory, socioeconomic, and political changes on the horizon that may significantly impact pharma companies’ bottom lines.[i] In a new white paper titled “Five Pharma Trends that Will Have the Biggest Impact in 2017,”
Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics industries, outlined the most critical issues affecting the pharmaceutical industry in 2017. The following are several of the exigencies she points to as this year’s major pharma forces.
Ushering In the eCTD Era
The FDA has mandated that the transfer of all regulatory information to the agency must now be done in the electronic common technical document (eCTD) format. As of May 5, 2017, the required eCTD format will apply to all New Drug Applications (NDA), ANDA (Abbreviated NDAs), Biologics License Applications (BLA), and drug master file (DMF) submissions. This will be a significant—and potentially costly—shift for companies that have relied on paper-based systems to generate CTDs in the past and then outsourced their submission output and filing activities. Electronic tools that may have once seemed to be luxuries only the largest pharmaceutical companies could afford are quickly becoming essential components of conducting everyday business.
The firms that can rely on a proven enterprise document management system (EDMS) that is compatible with an eCTD publishing tool will have optimal control over their CTDs and therefore will be in the best position to meet FDA demands in the age of electronic-only information transmission. To help companies reach that level of excellence and work out any kinks prior to the submission of their final eCTDs, the Center for Drug Evaluation and Research (CDER) invites pharmaceutical companies to submit sample eCTDs
to get feedback that can help resolve potential technical issues.
TMF Inspection Readiness is More Crucial Than Ever
It is widely known that a well-maintained electronic trial master file (eTMF) dramatically improves a company’s overall performance and makes it easier to manage clinical trials. The most beneficial side effect of good eTMF management, however, is that it keeps a pharmaceutical company in the good graces of regulatory inspectors. While fewer than half of clinical operations were using the eTMF format as recently as 2012, that number increased to nearly 70 percent by 2015. This upsurge, in tandem with electronically oriented policy shifts in other related areas, is indicative that the proliferation of effective eTMF management systems will continue to increase. [ii]
Increasing Focus on Supplier Quality Management
At the 2016 InformEx expo, a pharmaceutical technical lead of The British Standards Institute (BSI) told a group of fine and specialty chemical industry experts that regulatory agencies will now be delving more deeply into pharmaceutical companies’ supply chains than ever before.[iii]
As reliance on suppliers, vendors, and other external agents continues to surge in the industry—and as dual- and multi-sourcing becomes a more popular means of mitigating risk—it is becoming progressively more essential for sponsor companies to appropriately and thoroughly oversee their third-party vendors and partners. To establish compliant supplier management programs, pharma organizations need quality systems that provide maximum visibility into vendor activities. A centralized, integrated software solution for managing suppliers
and monitoring and tracking their status and input can be an indispensable tool for improving communication with external parties and maintain supplier compliance.
Potential Changes to Regulatory Standards
In his first month in office, President Donald Trump told a gathering of pharmaceutical executives that he plans to lead an initiative to “get rid of a tremendous number of regulations” and institute trade policies that will be more beneficial to U.S. drug manufacturers.[iv]
In another move that sent shockwaves through FDA-influenced industries, the president signed an executive order requiring the revocation of two existing regulations each time a new regulation is enacted.[v]
Whether or not these overtures will realistically have long-lasting effects is yet to be determined, but pharmaceutical companies and other organizations in related industries are anxiously anticipating any sweeping ramifications these regulatory pivots or any other legislative upheavals may cause.
Regardless of whether the changes to global regulations are broad paradigm shifts or merely minor, incremental policy changes, pharmaceutical companies are likely to continue to gravitate to solutions that are geared toward facilitating compliance with the most current and far-reaching regulations (such as FDA, MHRA, EMA, and MHLW rules), guidelines (including EU Annex 11 and ICH), and standards (ISO, GxP, and EU GMP). Whatever regulatory policies are ultimately instituted, compliance will always be the pharmaceutical industry’s foremost goal.
Do you agree that these are the main trends that will have the biggest impact on the pharmaceutical industry in 2017? What other trends do you expect to see this year? How is your organization planning to meet the new challenges 2017 will inevitably bring? Share your comments below.
James Jardineis a Marketing Communications Specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.