EU MDCG: Revised Device Surveillance Guidance
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
EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies
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
UK MHRA: "AI Airlock" The Regulatory Sandbox for AIaMD
EMA Guidance: EudraVigilance Registration Documents
Australia TGA: Regulation of Software based Medical Devices
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
USFDA Med Dev: Guidance on Remanufacturing of Medical Devices
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)
USFDA MD Guidance: Enforcement Policies for Tests During a Section 564 Declared Emergency & for Certain In Vitro Diagnostic Devices
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Australia TGA: Regulatory requirements for in-house IVDs