Bulk Pharmaceuticals Task Force (BPTF) advocacy reflects an active role in a continuing dialogue with the Food and Drug Administration (FDA) and other regulatory authorities on issues related to drug safety and quality. This advocacy requires engagement with multiple stakeholders and a multi-faceted approach:
Below are examples of BPTF advocacy:
Food and Drug Administration Comments
Following is a listing of recent comments submitted to FDA on behalf of BPTF member companies:
U.S. Pharmacopeial Convention (USP) Comments
European Medicines Agency (EMA) Comments
European Commission (EC) Comments
Templates Prepared by BPTF for Industry Use
SOCMA-EFCG White Paper
Priorities Moving Forward - What Lies Ahead?
The Bulk Pharmaceuticals Task Force will continue to develop industry positions and interact with governmental agencies on emerging regulations, legislation and guidelines impacting drug safety and to discuss interpretations of regulations that may impact member companies. BPTF sponsors and conducts programs of interest to the members and provides networking opportunities for mutual assistance and education.
A key area of interest to BPTF members is the implementation of GDUFA. It will be important to continue to monitor FDA implementation activities to ensure goals established in GDUFA will be met and to provide assistance to member companies in meeting the requirements of the current five-year program. In addition, BPTF intends to make its collective voice heard during the upcoming reauthorization process to identify and champion those aspects of GDUFA that require change and improvement, and ensure that industry obtains appropriate value for its investment in this user fee program.