Philippines FDA: Guidelines on the Unified Licensing Requirements
USFDA Guidance : GDUFA III User Fees & 4 Generic Drug related Guidances
SAPHRA (ECTD & Human Medicines Unit): Variation Communication Guideline
USFDA Guide: Review of DMF in Advance of Certain ANDA Submissions & Facility Readiness-Under GDUFA
USFDA Guidance: Size, Shape, & Other Physical Attributes of Generic Tablets and Capsules
Swissmedic Guidance: Medicinal Product Name HMV4
Canada Guidance: Regulatory Enrolment Process (REP)
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
UK MHRA: European Commission Decision Reliance Procedure (EC DRP) Extension
EMA Guidance: Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources
MHRA Guidance: Good Clinical Practice for Clinical Trials
USFDA Guidance: Clinical Investigations of Medical Products Involving Children
USFDA Guidance: Distribution of Approved Naloxone Products -Immediately-in-Effect
Artificial Intelligence in Regulatory Affairs
UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
USFDA Guide: Updated eCTD 4.0 - TECHNICAL CONFORMANCE GUIDE,
Swissmedic Guidance: eDok Submission Update
ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES
Indian Pharmacopoeia Commission (IPC) Joins Pharmacopoeial Discussion Group for Global Expansion
USFDA: Annual Summary Reporting Requirements -Right to Try Act -Final Rule