News in Depth

The advancing CMC innovation support programs at EMA and FDA are highly complementary in focus and structure, with distributed and continuous manufacturing drawing significant up-front attention at both agencies.

On both sides of the Atlantic, a significant effort is underway to deepen the regulator/industry/academia communication needed to realize the potential for technological advancement in the manufacturing and control arena. In this four-part story, IPQ explores the latest advancements in the EMA and FDA innovation support programs and the priorities that are now drawing front-burner attention.

PART I: European Regulatory Network Support for Manufacturing Innovation

PART II: FDA’s Expanding Engagement with Advanced Technologies

PART III: Barriers to CM Adoption Explored at USP/RAPS Workshop

[Part IV will be published later next week.]

Full implementation of the revisions that have been made to ICH’s Q9 guideline on quality risk management (QRM) will entail a heightened focus on how to best integrate knowledge into risk-based decision-making (RBDM) and is expected to be a mid-term rather than short-term project, according to the rapporteur and members of the guideline revision Expert Working Group (EWG).

Part I: Insights from Expert Working Group Members on ICH Q9 Revisions

Part II: Panel Discussion Among PRST Meeting KM/QRM Experts

Part III: Risk-Based Decision-Making

Part IV: Risk Management in Drug Shortage Prevention

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is stressing that food, chemical, and environmental legislation should be developed and implemented with the impact on medicines in mind and that EMA and other regulatory authorities and stakeholders need to be more directly engaged to make sure that the outcomes align with the EU’s healthcare objectives.

PART I: The Need for Pharma Stakeholder Engagement

PART II: EU PFAS Action and Pharma Mitigation Needs

PART III: Industry and EMA on F-gases and Hydrofluorocarbons in Inhalation Products

PART IV: DIA Europe Legislative Session Panel Discussion

PART V: Intensified Industry Dialogue on TiO2 and Nanoparticles Ahead of More EMA Review

The International Pharmaceutical Excipients Council (IPEC) is working with other groups of experts across the stakeholder community to prevent questionable safety concerns raised in Europe about the use of titanium dioxide in foods from resulting in a ban on its use in formulating drug products.

Because of a link between food and pharma legislation in Europe, a January 2022 EU regulation removing titanium dioxide (TiO2) from the list of authorized food additives could result in it not being allowed in pharmaceuticals, unless a second review by the European Medicines Agency – to be completed by April 2024 – provides sufficient justification for its continued use. Industry input to the updated EMA review is due by November 2023.

[To help expand awareness of the TiO2 issue and its implications, IPQ is making the full story openly available. Click here to read the story.]

USP is continuing to evolve and refine its strategies for providing standards that can keep pace with and support the rapid advances in biotechnology taking place across the monoclonal antibody (mAb), vaccine, and the cell and gene therapy (CGT) landscape.

Part I: USP Bio Stakeholder Forum Opening Remarks and Mass Spec Standards for Proteins

Part II: USP's CGT Initiatives

Part III: FDA and Industry Experience with CAR T Potency Testing

Part IV: Update on USP Strategies and Initiatives in the MAb, Vaccine, and CGT Arena

The US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation, as the learnings from the pandemic are further digested. The five-part IPQ story provides a wealth of insights from key leaders and policy makers on the innovation issues at play and how NIIMBL and other organizations are seeking to address them in the US and internationally.

Part I: NIIMBL and its “Going First Together” Mantra

Part II: US Manufacturing Innovation Leaders Weigh In

Part III: The Importance of Process and Facility Innovation in Global Health

Part IV: Charting the Advanced Therapy CMC Pathways and Other NIIMBL Projects

Part V: CBER’s Marks on Taking CGTs to the Next Level

More sensitive and selective methodologies have facilitated the identification and quantification of elemental impurities (EIs) in pharmaceuticals and the movement away from the old heavy metal analytical tests to the newer risk-based assessment strategy of ICH Q3D.

Part I: Role of PQRI/FDA Workshop in Q3D Implementation Dialogue

Part II: Regulatory Experience and Perspectives in Implementing Q3D

Part III: Pharmacopeial Harmonization with ICH Q3D

Part IV: Outcomes of PQRI Study on Variability in Elemental Impurity Analysis

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 three parts of the IPQ story review the progress of these efforts.

Part I: Europe’s Focus on CMC Innovation and Agile Regulation

Part II: Innovation Issues Explored at CASSS CMC Forum in Europe

Part III: MHRA’s “New Era in Regulation”