Digital technologies will help safeguard drug and vaccine supplies during health emergencies according to the European Medicines Agency (EMA), which says efforts to foster manufacturing innovation are on track.
The regulator discussed digitization in a progress report on the European Medicines Agencies Network Strategy (EMANS)—European Union’s (EU’s) plan for ensuring the availability of medicines during health threats. Encouraging the use of digital manufacturing tech is a core aim, according to Tony Humphreys, regulatory science adviser at the EMA.
“Digitalization within pharmaceutical manufacturing leads to more robust and flexible processes enhancing continuity of supply of effective and safe medicines,” he points out. “Regulatory facilitation of these novel manufacturing technologies unlocks the potential for increased productivity, improved compliance, enhanced systems connectivity, and actionable insights into the production processes that are essential to ensure continuity of supply in a globalized operational environment.”
Quality innovation group
In the three years since EMANS’ launch industry use of innovative technologies has increased, according to the authors of the report. They cite the good practice guide on shortage prevention—introduced in February 2023 under EMANS—as an important step, explaining that more drug firms now use digital technology to track products through supply chains than ever before.
Likewise, the EMA’s quality innovation group (QIG), a discussion forum for industry and regulators established under EMANS, has had a positive impact on manufacturing innovation, continue the authors.
“The topics discussed reflected the priority topics identified through a stakeholders’ survey in 2022. These included continuous manufacturing (CM), decentralized manufacturing (DM), Pharma 4.0, AI, and digitalization, they write. “Following the meetings, reports have been written highlighting the challenges raised by industry, possible solutions and the actions that QIG will take to help address these challenges.”
The report also points to the EMA’s collaboration with the U.S. FDA on an aligned regulatory framework that supports innovation in manufacturing as an important EMANS achievement: “In 2023 following an FDA visit at the EMA it has been agreed that FDA and QIG will work closely to advance and align regulatory thinking in the area of advanced manufacturing.”
Action plan
The idea is to develop an action plan and agree on priority topics for joint guidance development as well as on a timetable for regular product-related information exchanges and collaborative advice assessments.
For Zaïde Frias, head of the EMA’s Digital Business Transformation Taskforce, such collaborations, along with initiatives like the EU Network Training Center Learning Management System (NTC), create an environment that supports innovation.
“Digitalization of EU regulatory network operations is essential to bring efficiencies today but also prepare foundations for the future,” she explains. “We are investing in experimentation with emerging technologies, including artificial intelligence, while building essential capabilities that underpin the optimization of our regulatory work.
“The EU NTC is another key part of the response towards ensuring sustainable capacity and capabilities in the EU regulatory system. It represents the joining of forces to build a network of trainers and learners ready to tackle the regulatory challenges of today and tomorrow.”
