West's Regulatory Affairs Team

April 07, 2016

Recent Changes to West’s Elastomer Formulation DMF

West has recently converted its Elastomer Formulation Drug Master Files (DMFs) to an electronic (eCTD) format.
This change is the result of West’s direct collaboration with the U.S. Food and Drug Administration (FDA) and Health Canada to improve the agency review process of our customers’ pharmaceutical applications. Moving forward, West customers will notice a few changes in their Letters of Authorization/Access (LOAs). Since this is a conversion from paper to CTD format, the critical content of our regulatory files has not changed.

LOAs for FDA DMFs will reference new DMF numbers

West submitted new eCTD Elastomer Formulation DMFs to the Center for Drug Evaluation and Review (CDER) and the Center for Biologics Evaluation and Review (CBER), and a new, non-electronic CTD document to the Center for Devices and Radiologic  Health (CDRH).

All LOA requests for the FDA will now reference these new DMF numbers.

FDA Review Center Paper DMF No. New DMF No.
CBER DMF# 1998 STN 016769
CDER DMF# 1546 DMF 030048
CDRH MAF# 323 MAF 2694

Validity of historical FDA DMF LOAs

West customers currently using LOAs to reference our existing US DMFs (#1546, #1998, and #323) can continue to do so. These DMFs are still active files, they will be maintained for the foreseeable future, and the FDA still considers LOAs for these files to be valid. Customers can continue to reference historical LOAs to West’s DMFs and the FDA is authorized to review the information in support of their drug applications.

New LOA requests will only be issued to the new DMFs in eCTD format per West’s agreement with the FDA.

The Health Canada DMF number has not changed

The Formulation DMF (1976-001) held with Health Canada has also been converted to eCTD format; however Health Canada has opted to maintain the same file number. All LOAs for historical paper and electronic DMF are valid per West’s agreement with Health Canada.