The experience of the pandemic has underscored the criticality of assuring that regulatory processes keep pace with innovation in the manufacturing and control arena and has spurred the efforts that were underway in Europe to assess the issues involved and implement the adaptations needed to address them.
The recognition of these assessment and implementation challenges has led to the recent creation by the EMA of a “Quality Innovation Group” (QIG), tasked with helping ensure that the EU regulatory framework and processes are reliable and predictable for developers and generally align with and foster innovation in the EU. The QIG will aim to support the progression of these new technologies into regulatory submissions and routine manufacturing and control operations throughout the product lifecycle.
During 2022, EMA has clarified the QIG’s mandate and selected eight core members from across the European network of review and inspection experts. The group began meeting during the fall.
The EMA innovation support efforts parallel in structure and function those taking place at FDA through CDER’s Emerging Technology Program (ETP) and CBER’s Advanced Technology Team (CATT), and the agency’s umbrella Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) and Center for the Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals (CAMPB) initiatives. [See IPQ August 28, 2022 and October 17, 2022 for an in-depth review of the FDA innovation support efforts.]
In a similar timeframe, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been repurposing and restructuring to enable a more patient-focused, streamlined approach to support innovation.
â—Ź Part I: Europe’s Focus on CMC Innovation and Agile Regulation
The first part of the story explores the increased attention that CMC innovation and agile regulation has received in Europe since the pandemic began. It begins with insights on the challenges for regulators in keeping pace with innovation and creating agile regulation while maintaining adequate regulatory oversight provided at a November 2020 ISPE Pharma 4.0 conference by two European regulatory veterans who are now serving as consultants, Mark Birse and Bernd Bödecker.
At the January 2022 CASSS WCBP conference, EMA’s Veronika Jekerle shed light on the CMC and GMP innovation trends EMA has been seeing via its Innovation Task Force (ITF) and how the agency has been addressing regulatory and technical issues in its support efforts. At ISPE Europe in April, EMA’s Evdokia Korakianiti provided further insights on the EU vision for innovation, the lack of barriers in current EU legislation, and the new Quality Innovation Group (QIG). Korakianiti also highlighted the collaborative efforts of the International Coalition of Medicines Regulatory Authorities.
â—Ź Part II: Innovation Issues Explored at CASSS CMC Forum in Europe
In this part of the story, the focus turns to the current implementation stage of the Quality Innovation Group. Speaking at the October 2022 CASSS CMC Strategy Forum Europe, EMA’s Robert Bream elaborated on the vision for the QIG, its interactions with other groups/organizations, how the ITF compares with the QIG, outcomes of the QIG stakeholder survey, and the group’s current activity and plans.
Also included is a review at the CASSS forum of the EFPIA responses to the QIG survey by GSK’s Matt Popkin, and an in-depth panel discussion between leaders from regulatory agencies and industry on enabling innovation in products and processes. The dialogue centered around developing timely, science-based, and collaborative guidance to meet the needs of a wide range of stakeholders.
â—Ź Part III: MHRA Support for Manufacturing Innovation
Prior to Brexit, MHRA played a leading role in the European network and in helping define the EU’s long-term strategy around supporting innovation. Part III reviews how MHRA since Brexit has been transforming its own structure and processes to further the deployment of advanced technologies.
MHRA’s James Pound and Ian Rees participated in a June 2022 Medicines Manufacturing Industry Partnership conference, where they had the opportunity to discuss the agency’s restructuring and vision and the contribution of its Innovation Office. In introducing the MMIP conference, Pfizer’s Brian Henry reviewed the role of the MMIP and its recent achievements. This part also highlights some of the UK’s initiatives in support of its 2021 Life Sciences Vision and other recent government strategy efforts.
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