Regulatory Blog

USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format

SFDA's Guidance on Data Requirements for the Renewal of Marketing Authorizations Drug Products

India MoH's - Draft Proposal for adding QR Codes for important SCHEDULE H2 Drugs

South Africa SAPHRA - Post-marketing Reporting of Adverse Drug Reaction

Philippines FDA - Guidelines on Abridged and Verification Review Pathways for New Drug Registration

Ireland's HPRA -Guide to Performance Studies Conducted in Ireland

USFDA Guidance on Technical Performance Assessment of Quantitative Imaging in Radiological Device

ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation

USFDA Guidance - Assessment of the UI of a Drug-Device Combination - Pre-ANDA or ANDA Communication

Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT

Guidance documents for Therapeutic Products

Swissmedic - Guidance on known Active Pharmaceutical Substance & Time limits for Authorisation

USFDA's Guidance of Electromagnetic Compatibility (EMC) of Medical Devices

EMA- New Guidance on Complex Clinical Trials