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ICH’s 2003 Vision of a Harmonized Quality Regulatory Approach that Fosters Innovation Continued to Take Form in 2023 and 2024

The ICH goal of evolving its quality guideline series to keep pace with and provide support for technological innovation has continued to be realized in 2023 and 2024.

The goal is not a new one for ICH but was clearly articulated back in 2003 in an overarching “Quality Vision” calling for the development of “a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.”

● PART I: Analytics Guidelines Q14 and Q2(R2)
● PART II: Viral Safety Guideline Q5A(R2)
● PART III: ICH Q1/Q5C Revision and Stability Evaluation
● PART IV: The Role of the New CGT Discussion Group
● PART V: ICH’s M4Q(R2) on the Quality Component of the CTD

The Challenges of Evolving Pharma from a Compliance to a Risk-Based Control Strategy Mindset Are Drawing Conference Spotlight

The challenges of and drivers for evolving the pharmaceutical industry from a compliance-oriented mindset to one based on a control strategy embodying the risk management principles of ICH Q9(R1) are at the forefront of the industry/regulator dialogue at public forums, as the complexities of processes, products, and big data handling continue to expand.

PART I: Critical Thinking in Risk Management and Data Governance
PART II: Quality Culture/Oversight in Aseptic Operations
PART III: Takeda’s Annex 1-Based Global CCS Program
PART IV: QRM Tools in Root Cause Analysis
PART V: Annex 1 Revisions and the CCS Implications

CMC Innovation Support Programs Advance at EMA and FDA, with Distributed and Continuous Manufacturing on Front Burner

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: Distributed/POC Manufacturing and the CMC/Quality Regulatory Paradigm

Implementing ICH Q9(R1) Will Entail a Heightened Focus on Integrating Knowledge into Risk-Based Decision-Making

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

Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food, Chemical, and Environmental Legislation

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

IPEC is Helping Marshal Expertise Across Stakeholders to Forestall a Potential Titanium Dioxide Ban in Pharmaceuticals

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 Continues to Refine Its Strategies for Keeping Pace with and Supporting the Rapidly Advancing Biotechnology in the MAb, Vaccine and CGT Arenas

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

Government/Industry/Academia Collaborative Efforts to De-Risk and Accelerate Manufacturing Innovation Draw Strength from Pandemic Learnings

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