intuslegerechemia https://validator.w3.org/feed/docs/rss2.html US FDA: Data Integrity for In Vivo Bioavailability and Bioequivalence Studies US FDA: Handling and Retention of Bioavailability (BA) and Bioequivalence (BE) Testing Samples EMA has published a draft reflection paper on the use of Real-World Data in Non-Interventional Studies Real-world evidence provided by EMA Home The EMA updates Q&A document concerning centralized procedures EU-GMP Chapter VII: is a “Chain of Contracts” allowed? EMA Draft Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle MRA between Swissmedic AND FDA The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process The FDA announced the availability of the Questions and Answers Draft Guidance on Remote Regulatory Assessments The Indian Ministry of Health revises the GMP standards Updates to Water Monographs in European Pharmacopoeia (Ph. Eur. 12.3) The 2026 EU GMP Annex 15 revision for Active Substances Evidence-based Classification Reviews (EBRs) on Herbal Medicines Good Distribution Practice (GDP) in the US: FDA update Drug Supply Chain Security Act (DSCSA) implementation SwissMedic Publishes Q&A Document on interpretation of GMP Annex 1 The ICH Q2(R2) and new Q14 Guidelines reached Step 4 and were adopted by the ICH Assembly Regulatory Members APIC has released an updated FAQ on data integrity. APIC: Updated ICH Q7 “How to do”- document US FDA: Carcinogenic Potency Categorization Approach for Nitrosamine Impurities New draft of FDA Guidance on Artificial Intelligence EDQM publishes revised Ph. Eur. Water Monographs for public comment EMA/CHMP has published the new draft revision of the “Guideline on the chemistry of active substances” Swissmedic has issued an updated version of the Technical Interpretation “Responsible Person: Requirements” Revisions of the chapters “’Balances <41>” and “Weighing on an Analytical Scale <1251>” have been published on the website of the Pharmacopeial Forum of the USP for comments GMP implementation regulations for veterinary products published in the Official Journal FDA Issues New draft Guidance on GMP for Medical Gases FDA Moves to Streamline Approach to Biosimilars EDQM updates e-submission requirements for CEP applications Transport route profiling qualification: USP–NF PF 51(5) Draft Proposal Revision of Good Manufacturing Practice (GMP) Guidelines Glass Containers for Pharmaceutical Use Revision of the EU GMP Guide Annex 11 “Computerised Systems” – Presentation of Concept Paper APIC: New Update of the ICH Q7 “How to do” Document EMA updated Q&As on QP Declaration Microbiological quality – EDQM is asking for comments on the revised chapters 5.1.6. ICH Q1 guideline update – What’s Changing in Stability Testing APIC updated the Nitrosamine Risk Management Guidance EMA/CMDh updated Q&A document on nitrosamines Swissmedic has issued an updated version of the Guideline for Conducting Inspections EMA interprets and comments on the role of the QP in supply chain traceability EMA has published “Overview of recommendations for the uses of herbal medicinal products in the paediatric population” FDA Guidance on the Identification of Medicinal Products — Implementation and Use New Definition of Pharmaceutical Grade Plastic Packaging Materials EDQM publishes draft General Chapter “Quality of Data” for Comments USP proposes to modify the glass classifications in General Chapter <660> and to create additional flexibility for packaging and storage requirements in specified monographs PIC/S: PUBLISHED NEW DOCUMENTS FOR GDP INSPECTIONS New Code of Conduct for QPs developed by EQPA Declaration of Herbal Substances and Herbal Preparations in HMPs