By John DiLoreto, Executive Director of the Bulk Pharmaceuticals Task Force
The Bulk Pharmaceuticals Task Force (BPTF) hosted its annual Spring Meeting here at the Society for Chemical Manufacturers and Affiliates (SOCMA) headquarters to discuss key issues and challenges facing the pharmaceutical industry and hear from industry experts.
BPTF’s Annual Meeting featured speaker was Dave Skanchy, Director of the Drug Master File (DMF) Review Staff at the Food and Drug Administration (FDA), who addressed many of the issues BPTF members are having with various aspects of DMF submissions.
BPTF members also discussed proposed China tariffs, Generic Drug User Fee Act II implementation, atypical actives, Canada’s Health Risk Classification Guide, ICH Q12 and quality metrics, among others.
BPTF Chair Chuck Stankovic kicked off the afternoon with speakers from Europe’s Active Pharmaceutical Ingredient Committee (APIC), who discussed issues of particular interest to their companies and common concerns with FDA’s implementation of GDUFA II. Jennifer Abril, SOCMA President and CEO, also shared highlights on the association’s new direction and partnership with BPTF.
“Our members continue to work to create a proactive dialogue around quality compliance, regulatory issues and advocacy on behalf of active pharmaceutical ingredient manufacturers,” said BPTF Executive Director John DiLoreto. “We constantly look for ways to expand BPTF as an industry leader, and we are actively engaged with SOCMA staff and industry stakeholders to provide resources and address current policy challenges.”
As the Task Force looks ahead into 2019, a main priority will be to successfully convey to FDA the challenges and impact GDUFA II has on the industry. BPTF is working to strengthen its partnership with the agency, as well as a develop a list of standards and outcomes of what needs to be changed.
BPTF is an industry trade organization representing manufacturers of active pharmaceutical ingredients (APIs), intermediates and excipients. Created as an affiliate organization of SOCMA in response to industry demands, BPTF addresses regulatory and plant operations issues related to current Good Manufacturing Practices (cGMP) compliance.