Swissmedic Guidance: Requesting Product Certificates (CPP)
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
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
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