BPTF advocacy reflects an active role in a continuing dialogue with the Food and Drug Administration and other regulatory authorities on issues related to drug safety and quality. This advocacy requires engagement with multiple stakeholders and a multi-faceted approach:

 

Engagement

•  BPTF  is a key stakeholder in negotiations with FDA to authorize and implement a generic drug user fee program (GDUFA).

• BPTF routinely provides stakeholder input on proposed FDA and EMA regulations and guidances to ensure that member company concerns  are addressed.

• BPTF keeps members aware of current and impending guidances, regulations and legislation related to active pharmaceutical ingredients and excipients.

• BPTF has become a trusted voice for generic API manufacturers and is routinely sought out by the press for important information on news impacting industry members.

• BPTF has developed tools for industry and made them available to assist companies wishing to strengthen their adherence to cGMPs.

 

Advocacy

• BPTF provides Congressional testimony when warranted as important stakeholders in the active pharmaceutical ingredient sector.

• BPTF provides input to other pharma stakeholders and industry regulatory groups to reinforce the need for drug safety throughout the supply chain.

• BPTF has established working relationships with organizations such as Rx-360, IPEC, APIC, European Fine Chemicals Group (EFCG) and The PEW Charitable Trusts to collaborate on drug safety and quality initiatives.

• BPTF is a member of the Coalition for the Rational Implementation of the USP Elemental Impurities Requirements.