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IPQ Inside the global regulatory dialogue

Excipient Regulatory Approaches Globally Differ Widely in Registration, GMP, DMF, and Application Submission Expectations

Jun 17th, 2016

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An analysis of the way excipients are handled by regulators around the world reveals significant differences in the registration/licensing and GMP requirements as well as both the form and content of what needs to be submitted to support drug applications. 

Regulatory agencies differ markedly in the specificity of their requirements for excipients, and whether and how their regulatory processes incorporate registration, master files, specific manufacturing/monograph standards, and approved ingredient lists.

In an IPEC-Americas workshop on “global regulatory strategies” that preceded the ExcipientFest conference held in Baltimore, Maryland in late April, a panel of industry experts explored the similarities and differences in the way excipients are being handled by eleven of the major countries/regions around the world.

Leading the review were four key players in the IPEC-Americas organization: ● Dow Corning Healthcare Global Regulatory Compliance Manager Kathy Ulman ● Lubrizol LifeSciences Global Regulatory Affairs and Strategies Manager Meera Raghuram ● Ashland Pharmaceuticals and Nutrition Global Regulatory Affairs Manager Priscilla Zawislak, and ● Colorcon Global Regulatory Affairs Director Dave Schoneker.

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