Variations and Changes – NDAs, ANDAs, DMFs, Marketing Authorisations, Dossiers, ASMF, APIMF, CEPs, WHO Prequalification (FPPs & APIMFs) – Qvents

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3 minutes read Guidelines

Updated on March 17, 2025

Updated on March 17, 2025

USFDA: Changes to an Approved NDA or ANDA
USFDA: Changes to an Approved NDA or ANDA: Questions and Answers Guidance for Industry
USFDA: Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes
USFDA: SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
USFDA: SUPAC-IR – Questions and Answers about SUPAC-IR Guidance
USFDA: SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
USFDA: SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
USFDA: SUPAC: Manufacturing Equipment Addendum
USFDA: Postapproval Changes to Drug Substances
USFDA: CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
USFDA: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
USFDA: PAC-ATLS: Postapproval Changes – Analytical Testing Laboratory Sites
USFDA: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
USFDA: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
EMA, EC ( European Commission) ‘Variations Guidelines’ 2013/C 223/01 (EC) No 1234/2008 of 24 November 2008)
EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Europe: CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 (March 2023)
EMA: Variations including extensions of marketing authorisationsCEP: Notifications, Revisions, Renewals and Sister Files
Europe CMDh – Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) – Variation
Europe CMDh – Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) – Questions & Answers – Variation
CEP / EDQM: Notifications, Revisions, Renewals and Sister Files
CEP / EDQM: Classification of changes; Submit changes; Sister files
CEP / EDQM: Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2)
CEP / EDQM: Management of applications for new Certificates of Suitability, Requests for Revision
CEP / EDQM: Guidance on applications for «sister files» (PA/PH/CEP (09) 141)
CEP / EDQM: Certification Policy Documents & Guidelines
WHO: Amendments to APIMFs;
WHO: Guidance on amendments to an active pharmaceutical ingredient master file (APIMF) submitted in support of a prequalified pharmaceutical product (FPP) or prequalified active pharmaceutical ingredient
WHO: FAQ: Active pharmaceutical ingredient master file (APIMF) amendments
WHO: Variations to FPPs (Finished Pharmaceutical Products); Multisource Generic FPPs: Classification of variations and assessment timelines
WHO: FAQ: Variations to prequalified pharmaceutical products
WHO: TRS 981:Annex 3, WHO guidelines on variations to a prequalified product

Tags : Guidelines, Purified Water, Variations and Changes, Water for Injections, Water system

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