USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
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
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
UK MHRA: 150-Day Assessment for National Applications
USFDA's Notice: CMC Development & Readiness Pilot Program
DRAP Guidelines: Preparation of Summary of Product Characteristics (SmPC)
SFDA Guidance: Good Regulatory Practice & National Diagnostic Reference Levels
Denmark DMA: Current Danish QRD Template for Granting MA
USFDA Guidances: Preapproval Inspections & Drug Manufacturing Inspections
USFDA Guidances: Topical Generic Drug Products - ANDAs
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
USFDA Guidance: ANDA Submissions – Prior Approval Supplements - Under GDUFA
USFDA Guidance: Comparability Protocols for Postapproval Changes to CMC in an NDA, ANDA, or BLA
EMA Guidance: Scientific Advice and Protocol Assistance
UK MHRA Guidance: How to get a Parallel Import Licence in UK
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev