Top Industry News
- FDA Guidance for Providing Over-the-Counter Monograph Submissions in Electronic Format
- ANSM - European Regulations on Medical Devices and In Vitro Diagnostics: Publication of a “Consensus Statement” for the European Commission
- MHRA Guidance on Good Clinical Practice (GCP) for Clinical Trials
- Mexico Cofepris Submits a Standard for Consultation to Guarantee the Safety and Effectiveness of Medical Devices
- Deficiency Analysis in On-Site Good Manufacturing Practice (GMP) Inspections of Manufacturers for Medicinal Products and Cosmetics by NPRA
- ANVISA - Find Out More: Standard Operating Procedure for Risk Classification of Pending Drug Registration Issues
- FDA Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
- FDA: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
- ANVISA Discover CMED's New Standards Monitoring Panel
- Mexico Cofepris Approves Clinical Trial for Innovative Vaccine Against Melanoma
- MHRA - Medical Devices Given Exceptional Use Authorisations During the COVID-19 Pandemic
- The "Food Standards (Application A1257 – Australian native bee honey – Consequential Amendments) Variation" updates the Australia New Zealand Food Standards Code by including native bee honey in relevant sections, adjusting definitions, labeling requirements, and residue limits for food
- Amendment No. 229: Regulatory amendments to various standards and schedules in the Australia New Zealand Food Standards Code
- IMPORTANT – CTPA's Response to the UK REACH Consultation on ATRm
- IMPORTANT – CTPA Alerts on Non-compliant CPSRs in the UK
- Renew your AICIS Registration for 2024-25
- AICIS-Chemical Added to the Inventory Following Issue of an Assessment Certificate (early listing)