建立评估仿制药申请中非活性成分的全球框架-Dorsey.pdf

1、Building a Global Framework for Assessing Inactive Ingredients in Generic Drug ApplicationsPamela G.Dorsey,M.S.,Ph.D.Senior PharmacologistDivision of Bioequivalence III,Office of BioequivalenceCDER|US FDASBIA Generic Drug Forum April 9-10,2024fda.gov/cdersbiafda.gov/cdersbia2This presentation reflec

2、ts the views of the author and should not be construed to represent FDAs views or policies.Disclaimerfda.gov/cdersbiafda.gov/cdersbia3 Background Polling fellow Cluster participants Case Studies and Considerations DiscussionOverviewfda.gov/cdersbiafda.gov/cdersbia4Backgroundfda.gov/cdersbiafda.gov/c

3、dersbia5Assures the safety of inactive ingredients within drug products.Evaluation occurs during review of:Inactive Ingredient Controlled Correspondences(CCs)Abbreviated New Drug Applications(ANDAs)Evaluation in all populations the drug is indicated for(i.e.,adult and pediatric).Maximum daily exposu

4、re(MDE)for inactive ingredients calculated utilizing the maximum daily dose(MDD)from the reference listed drug(RLD)label.MDE for proposed inactive ingredient compared to amounts for the same inactive ingredient in approved NDAs or ANDAs.Applicants may submit clinical or toxicological data to use as

5、justification for a proposed inactive ingredient MDE in an ANDA submission.Inactive Ingredient Evaluationfda.gov/cdersbiafda.gov/cdersbia6 What are the practices for other regulatory jurisdictions?Are there commonalities or areas for alignment?Inactive Ingredient Evaluation Continuedfda.gov/cdersbia

6、fda.gov/cdersbia7Polling Fellow Cluster Membersfda.gov/cdersbiafda.gov/cdersbia8Comprised of membership from:US FDA Health Canada European Medicines Agency(EMA)Ministry of Health(Israel)Medicines and Healthcare products Regulatory Agency(UK)Swissmedic(Switzerland)Therapeutic Goods Administration(Aus