Regulatory Blog

Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form

Health Canada: Guidance on Master Files Procedures & Administrative Requirements

Singapore's HSA: Regulatory Updates for Therapeutic Product Registration

Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port

EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA

UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK

USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling

Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission

USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations

USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs

Switzerland's SwissMedic: Guidance on Authorisation Biosimilar

USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests

South Africa's (SAPHRA): Renewal Of Human Medicines Requirements and Process

Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format

USFDA Guidance: Content of Premarket Submissions for Device Software Functions

EMA Guidance: Paediatric Submissions Via Syncplicity Web Client

MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence

USFDA Guidance: Assessing User Fees Under the GDUFA of 2022

USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives

Philippines FDA: Guidelines on the Application for License to Operate