Global excipient and pharmaceutical manufacturers are weighing the complexities and consequences of the new “bundling review” requirement put in place by the China Food and Drug Administration (CFDA) in August 2016, which calls for excipient dossiers to be received, reviewed and approved as part of new drug applications.
Prior to the new requirements, an excipient supplier could prepare and submit an import drug license (IDL) for review and approval by a provincial FDA or CFDA. Under the new “bundling review,” the information on the excipient is submitted along with a specific drug application, with the excipient then getting approval for use in similar drug products (having the same route of delivery, the same or lower level of use, and the same supplier/grade of excipient) once the new drug product is approved.
The challenges created by the changing requirements in China were explored at an IPEC-Americas workshop on global excipient regulatory strategies that preceded the ExcipientFest conference held in Providence, Rhode Island, in late April. The workshop focused on the evolving regulatory requirements in Korea and Brazil, along with those in China.
Piggybacking off of a presentation at an IPEC Europe conference in February 2017 given by Colorcon China Regulatory Affairs Manager Colin Li, who is Chair of IPEC China, Colorcon Global Regulatory Affairs Director Dave Schoneker took the IPEC-Americas workshop attendees through the changes to the excipient regulations in China, the excipient dossier requirements for the bundling review published by CFDA in late November, 2016, and the challenges that the new regulatory approach creates for global companies. Schoneker is IPEC-Americas’ Vice-Chair for Science and Regulatory Policy.
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