Novel Excipients, DMFs, and Atypical Actives Among Pressing Issues on IPEC-Americas’ Front Burner

Novel excipients, drug master files (DMFs), and atypical actives are among the pressing issues on which the International Pharmaceutical Excipients Council (IPEC) is actively engaged with the major regulatory agencies and standards organizations around the world.

In her opening remarks at the 2018 ExcipientFest conference in San Juan, Puerto Rico at the beginning of May, Dow Global Regulatory Affairs Advocacy Manager Priscilla Zawislak, the current chair of IPEC-Americas and the IPEC Federation, began by thanking the attendees for coming to the island and helping support its recovery from the devastation suffered under Hurricane Maria. She then reviewed what IPEC’s journey has encompassed since the previous year’s ExcipientFest Americas and what the top priorities for the council are going forward.

Zawisklak highlighted the number and depth of the interactions that IPEC has been having with FDA and other agencies around the world, including China, Brazil and Mexico and with the US Pharmacopeia (USP), the European Directorate for the Quality of Medicines (EDQM), and other standards organizations.

She pointed out the increasing number of rules and guidances that have been emerging from FDA recently impacting excipients and IPEC-Americas’ frequent engagement with the agency on them and other initiatives of key concern.

IPEC-Americas close working relationship with FDA was marked by the appointment in February by Center for Drug Evaluation and Research (CDER) Director Janet Woodcock of Office of Executive Programs Lyndsay Hennessey as a point of contact for IPEC-Americas in addressing excipient issues.

“We felt that this is a really important step that FDA has taken,” Zawislak commented, showing “the interest they have in working with IPEC on a lot of different initiatives that we have had going on with them – to try to coordinate some things better and to make sure that things don’t fall through the cracks.”

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