In her opening remarks, Ms. Marie Antoinette Mariano, Vice Chairperson of the GPCCI Policy and Advocacy Committee, emphasized the importance of close collaboration between regulators and stakeholders as regulatory systems evolve to meet increasing demands for efficiency, transparency, and responsiveness. She highlighted the FDA’s critical role in safeguarding public health while shaping the regulatory environment for industries such as food, pharmaceuticals, cosmetics, and medical devices through policies and processes that promote product safety, quality, and compliance.
The session featured FDA Director General Atty. Paolo S. Teston, who presented updates on the agency’s regulatory modernization agenda, digital transformation initiatives, operational reforms, and efforts to improve service delivery. He also outlined the FDA’s five-year development plan, the continued adoption of risk-based and regulatory reliance approaches, and proposed reforms to the agency’s fee structure.
Key topics discussed during the briefing included:
- FDA performance updates, including the processing of more than 241,000 regulatory applications between May 2025 and May 2026;
- Digitalization initiatives, including enhanced e-services, Link.Biz and QR PH payment integration, and cloud-based systems;
- The implementation of the Electronic Over-the-Counter (EOTC) system;
- Risk-based regulatory approaches and expanded reliance on approvals from recognized international regulatory authorities; and
- Measures to improve access to affordable medicines, including VAT-exempt medicine endorsements and the implementation of the CREATE Act.
The presentation was followed by an interactive Q&A session moderated by Mr. Yves Aguilos, GPCCI Head of Government Affairs and Data Protection Officer. The discussion addressed several issues of importance to the business community, including:
- Criteria and implementation of risk classifications for foreign Good Manufacturing Practice (GMP) inspections and the expanded use of regulatory reliance mechanisms;
- Opportunities to further recognize approvals issued by highly regarded international regulatory authorities, including those within the European Union;
- Challenges in FDA application processing, including duplicate documentary requirements and upload limitations within the e-services platform; and
- Mechanisms for industry stakeholders to provide feedback and recommendations on FDA systems, processes, and reform initiatives.
The dialogue concluded with closing remarks from Mr. Yves Aguilos, who thanked Director General Teston and the FDA team for their openness, responsiveness, and commitment to engaging stakeholders through transparent and meaningful dialogue. He underscored the importance of continued collaboration in advancing regulatory reforms that support both public health objectives and business competitiveness.
The session highlighted the value of sustained engagement between regulators and the private sector in promoting transparent, efficient, and science-based regulatory frameworks. Through open discussion, participants explored operational challenges, reform priorities, and opportunities for stronger collaboration in support of public health, innovation, and economic growth.
GPCCI reaffirmed its commitment to the IMPACT Dialogue Series as a platform for meaningful stakeholder engagement and policy dialogue, with future exchanges planned with key regulatory agencies to promote regulatory coherence, trade facilitation, ease of doing business, and long-term economic competitiveness in the Philippines.
