Published in: European Pharmaceutical Review
Published on: April 29, 2022
From the Article:
The problem is, “no internationally harmonised guidance on E&L assessment and control exists” that specifically outlines the identification, qualification and reporting thresholds for E&Ls in multiple therapeutic modalities and dosage forms, including addressing safety assessment, the International Council for Harmonisation (ICH) highlighted in 2020. This, ICH noted, creates uncertainty for industry and regulators that could result in regulatory and patient-access delays.
In October 2021, the Product Quality Research Institute (PQRI) Parenteral and Ophthalmic Drug Products (PODP) L&E Working Group submitted recommendations for E&Ls in parenteral drug products (PDP) to the US Food and Drug Administration (FDA). These recommendations, the culmination of more than a decade of work by the group’s members and collaborators, are now available for the industry.