Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Singapore HSA MedDev: Regulatory Guidelines for Laboratory Developed Tests (LDTs)
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
Irelands HPRA MD Guide: Performance Studies Conducted in Ireland
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
MHRA Guidance: Licensing of Biosimilar Products
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA