SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
USFDA Guidance: Review of Drug Master Files in Advance of Certain ANDA Submissions
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
UK MHRA Guidance: Pre-submission Advice & Support
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Malaysia’s NPRA: Guidance for Bioequivalence Inspection
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
USFDA Guidance: Amendments to Abbreviated New Drug Applications (ANDAs) Under GDUFA
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)