Guideline on active substance master file procedure
Found 7 free book(s)Guideline on Active Substance Master File Procedure
www.ema.europa.euThe main objective of the Active Substance Master File (ASMF ) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or
STABILITY TESTING OF ACTIVE SUBSTANCES AND …
www.who.intWorking document QAS/06.179 page 2 REGIONAL GUIDELINE FOR THE WHO EASTERN MEDITERRANEAN REGION STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS DRAFT 2.0 19 April 2006 This guideline has been developed during the WHO EMRO Consultation on Regional
CMDv/BPG/012 BEST PRACTICE GUIDE for Informed …
www.hma.eu3. legal framework 4. references and related documents 5. general 6. description of the procedure annex 1: template for letter of access for an application under
Appendix 8 Data Requirements for New Medicine …
www.medsafe.govt.nzcontrol of starting materials, reagents, catalysts, solvents and any isolated intermediates, as well as any subsequent processing (eg, milling) of the bulk substance.
Forced degradation studies – comparison between …
dgra.dePage 1 1. Introduction and scope Forced degradation is an exposure of the drug substance or drug product to different stress conditions (more severe than accelerated conditions) [1] which results in relevant
Guideline on the specifications for provision of an ...
esubmission.ema.europa.euGuideline on specification for veterinary e-submissions Page 3 of 18 Introduction This Guidance Document is intended to assist applicants and regulators with submissions of …
ACTIVE PHARMACEUTICAL INGREDIENTS …
apic.cefic.orgAPIC_eCTD How to Do Page 4 INTRODUCTION eCTD is a topic of increasing interest in the pharmaceutical environment. In the past, the main focus for regulatory authorities was eCTD submissions sent via MAAs.