According to Iqvia’s recent report, “2025 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech,” 2025 promises to be an important year for the pharmaceutical and biotech industry on the safety and regulatory compliance front.
The paper gathers the views of a number of experts on expected developments in the fields of pharmacovigilance, medical information and lifecycle management highlighting some trends that will affect the industry as early as this year.
Integration of AI
One of the key elements analyzed by the report, of course, is the gradual implementation of artificial intelligence also in the management of regulatory compliance: while in the short term it may create several management problems, in the long term the integration of new technologies will enable the development of patient-centric solutions.
Iqvia experts especially insist on one point: AI will support human interaction-especially in medical information-but it is not intended to replace it. It will indeed facilitate the handling of large volumes of simple requests but leave human teams more time to focus on more complex issues and improve customer engagement.
According to Marcela Miño, global head, life-cycle management & regulatory affairs at the commercial analytics and healthcare intelligence company, AI will greatly improve the process of CMC (chemistry, manufacturing, and controls) variations, significantly speeding up the timelines required for regulatory submissions. Indeed, thanks to automated analysis tools, it will be possible to analyze the potential impact of variations and identify when changes need to be submitted to regulatory authorities.
Ana Pedro Jesuíno (associate director, marketed product safety in Iqvia) also predicts increased automation in pharmacovigilance, particularly through technologies such as automated data collection, processing, and initial reporting of adverse events, which will reduce human error and speed up reporting times. Post-approval life-cycle management, including label updates and registration renewals, should also progressively benefit from AI and data analytics tools, which will enable faster, more accurate and secure management of regulatory data.
In 2025, AI will continue to enhance, rather than replace, human interaction in Medical Information.
Simon Johns, director, medical information and marketed product safety, Iqvia
Regulatory authority initiatives
The document reflects a growing commitment by regulatory authorities to harmonize submission procedures, particularly through the increasing use of the electronic Common Technical Document (eCTD), the electronic version of the document that enables submission and review of the technical information required to obtain marketing authorization for new medicines.
In addition, a number of initiatives are noted, such as the Accumulus project and the Fda’s PRISM that are facilitating greater information exchange via cloud platforms, accelerating approvals especially in emerging markets.
The accumulus project is an initiative started by a nonprofit technology organization founded in 2020 and supported by ten big-pharma companies-Amgen, Astellas, Bristol Myers Squibb, GSK, Janssen, Lilly, Pfizer, Roche, Sanofi, andTakeda.
Its goal is to create a cloud-based platform for real-time information exchange between pharmaceutical companies and regulatory authorities throughout the product development and management cycle. Among its initiatives is sharing the “Fast healthcare interoperability resources implementation guide,” a global standard for pharmaceutical quality data exchange.
The PRISM (Post-licensure rapid immunization safety monitoring system), on the other hand, is the system developed by the Fda aimed at rapidly monitoring the safety of vaccines post-authorization, which now also leverages cloud technologies and advanced analytics to ensure more effective and timely monitoring of adverse events.
According to Patrick Brady, global head, therapeutic innovation & regulatory science at Iqvia, regulatory authorities are beginning to outline preliminary guidance on the use of artificial intelligence in pharmaceutical development, which often precedes the publication of guidelines. Should they be issued in the near future, they will likely cover a risk-based approach, with a focus on transparency and the ability to clearly explain how AI is used in various processes.
The strategic role of Qppv
The increasing use of multichannel platforms for medical information will require particular attention to ensure regulatory compliance.
Simon Johns explains that companies will have to maintain“appropriate guardrails”so that AI platforms use only approved content and handle confidential data with full respect for privacy.
A key element of compliance in the near future will be the “Qualified persons for pharmacovigilance (Qppv).” According to Ana Pedro Jesuíno, the Qppv will play a key role in ensuring that companies meet local requirements while complying with global procedures, serving as a liaison between companies and local regulatory authorities.