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”

EMA’s “toolbox guidance on scientific elements and regulatory tools to support quality data packages” for priority medicines targeting unmet medical needs, released in April 2022, reflects extensive stakeholder input and will evolve further as experience and learnings from the pandemic are evaluated.

Developed as an outcome of the 2018 joint EMA/FDA workshop on quality support to Priority Medicines (PRIME) and Breakthrough Therapy (BT) designated products, the guidance outlines the tools available in the EU to address the challenges in generating robust quality packages under accelerated conditions. It is applicable to small molecules, biological/biotech products, and advanced therapy medicinal products (ATMPs).

The guidance was drafted, consulted on, and revised throughout the COVID pandemic.

Part I: EMA Perspective on its Toolbox Guidance and OPEN Initiative

Part II: Industry View on Efficiency Tools and CMC Flexibility Learnings from COVID

Part III: Panel Discussion on Effective Tools for the Future

The successful development of mRNA-lipid nanoparticle (LNP) vaccines to address the COVID-19 pandemic has highlighted the power of nanoparticle-based formulations in producing safe and efficacious medicinal products.

Part I: Pfizer/BioNTech Lipid Challenges with mRNA-LNP COVID Vaccine

Part II: FDA’s Novel Excipient Review Pilot Program and Nanomaterials Guidance

Part III: USP’s Draft Guideline and Other Efforts on mRNA Vaccine Quality

Part IV: The EDQM Nanomedicines Dialogue and WHO on Regulating mRNA Vaccine Quality

Part V: Potency Assays for mRNA-LNP Vaccines

An FDA-commissioned study carried out through the National Academies of Sciences, Engineering, and Medicine (NASEM) is helping drive the industry/regulator agenda on advancing innovation in pharmaceutical manufacturing.

PART I: The NASEM Study and FDA Reflections

PART II: Existing Mechanisms to Enable Innovation

PART III: Challenges and Opportunities

PART IV: The Path Forward