Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product
EMA Guidance: EudraVigilance Registration Documents
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
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)
Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Australia TGA: Clinical Trial Notification (CTN) Form - User Guide