The ICH E20 draft Guideline on Adaptive Design for Clinical Trials has reached Step 2b of the ICH Process and entered the Step 3 public consultation period. The EU deadline for comments is 30 November 2025.
A revised version of Ph. Eur. chapter 3.2.1. Glass containers for pharmaceutical use has been published in Pharmeuropa 37.3. The comment deadline is 30 September 2025.
The ICH is currently working on two new Efficacy Guidelines: E21 on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials and E22 on General Considerations for Patient Preference Studies.
An FDA inspection revealed serious CGMP violations related to sampling, testing, and quality oversight at a U.S.-based drug manufacturer, underscoring the critical importance of scientifically sound sampling strategies.
The European Medicines Agency (EMA) has added new entries to its Product-specific bioequivalence guidance section, publishing updated guidelines for individual products.
In Pharmacopeial Forum 51(4), the USP has published a major revision of General Chapter <1039> Chemometrics for public comment. The update reflects the rapid evolution of the field, particularly driven by developments in machine learning and AI.
In the Pharmacopeial Forum, PF 51(4), a proposal for a new USP General Chapter <318> Nuclear Magnetic Resonance Spectroscopy Monomer Ratio Determination for LactideGlycolide Polymers has been published for public comment. Developed by the Excipients Test Methods Expert Committee, the chapter introduces a validated proton NMR method to quantify the monomer ratio in ring-opening copolymers of DL- or L-lactide and glycolide.
In Pharmacopeial Forum 51(4), the USP proposes a new General Chapter <1221> Ongoing Procedure Performance Verification. As Stage 3 of the Analytical Procedure Life Cycle (<1220>), the chapter introduces a risk-based approach to ensure consistent method performance during routine use. The draft is open for public comment until 30 September 2025.
The requirements for an audit trail can now be found almost everywhere in the relevant pharmaceutical regulations. Six experts from industry and regulatory authorities answer an extensive catalog of questions from various topic areas. Questions 1 and 2: From an inspector's perspective, what are the minimum requirements for the content of an audit trail and must an audit trail be printable?
The FDA published the final Guidance for Industry Conducting Remote Regulatory Assessments - Questions and Answers. The final guidance describes how FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products.