PCPI backs FDA plan to institutionalize Green Lane for medicines

The Philippine Chamber of Pharmaceutical Industry (PCPI) has expressed support for the Food and Drug Administration’s (FDA) move to institutionalize a “Green Lane” that would accelerate regulatory processes for health establishments and products aligned with national development priorities.

PCPI, the country’s largest association of local pharmaceutical companies with around 90 members, including Unilab Inc., said the initiative would help promote innovation, affordability and self-reliance in medicines. The chamber represents Filipino-owned pharmaceutical firms and has backed the expansion of the Green Lane through policy dialogues, public-private partnerships and regulatory engagements with the FDA, the Department of Health, the Anti-Red Tape Authority and other stakeholders.

“PCPI strongly applauds the FDA’s proactive regulatory reforms, which strike a balance between efficiency and unwavering safety standards,” PCPI President Dr. Lloyd Balajadia said. “This initiative will generate economic value, create more jobs, and help deliver life-saving medicines to patients faster—drawing from proven regulatory models in countries such as Singapore, India, and China.”

Balajadia said the Green Lane marks a key step toward strengthening the local pharmaceutical industry and building a more resilient and self-reliant medicines supply chain. “It recognizes the critical role of local manufacturers in ensuring the steady availability of affordable, high-quality medicines for Filipino patients,” he added.

Under the leadership of FDA Director General Atty. Paolo S. Teston, the Green Lane initiative aims to establish a regulatory pathway that prioritizes applications from qualified local manufacturers, particularly those producing essential and critical medicines. The framework is designed to provide streamlined review timelines, clearer documentation requirements and closer coordination between regulators and manufacturers, while maintaining the FDA’s standards on safety, quality and efficacy.

PCPI said local pharmaceutical companies play a vital role in maintaining a stable medicine supply, especially during public health emergencies. The COVID-19 pandemic, global supply chain disruptions and geopolitical tensions have highlighted the risks of heavy reliance on imported medicines and active pharmaceutical ingredients.

“Local manufacturers are often the first to respond to sudden spikes in demand for essential medicines,” PCPI said. “An institutionalized Green Lane will allow them to bring products to market faster, while remaining fully compliant with stringent regulatory requirements.”

The chamber also noted that the initiative aligns with national priorities under the Universal Health Care Law and the Philippine Pharmaceutical Industry Roadmap, supporting efforts to reduce import dependence, improve health security, promote sustainable industrial growth and generate employment.

PCPI welcomed what it described as the FDA leadership’s understanding of the domestic pharmaceutical sector’s capabilities, saying the Green Lane could help position the Philippines as a competitive pharmaceutical manufacturing hub in the region.

The group urged the swift finalization of the Green Lane guidelines through continued consultations and stakeholder engagement to advance regulatory reforms that benefit both public health and industry development.