EMA Guidance: Proposed Amendments - Variations Categories and Procedures
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
EMA Guidance: Procedural Advice on Paediatric Applications
EMA Guidance: IRIS Guide for Applicants
ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
USFDA Guidance: Platform Technology Designation Program for Drug Development
Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
EDQM Guidance: Content of the Dossier for Sterile Substances
Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use
South Africa (SAPHRA): Reliance Guideline
Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product
EMA Guidance: EudraVigilance Registration Documents
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)
Switzerland's SwissMedic: Guidance for requesting Product Certificates (CPP)
Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling