PCPI backs FDA move to institutionalize Green Lanes for health establishments, products

The Philippine Chamber of Pharmaceutical Industry (PCPI), which unites Filipino-owned pharmaceutical companies to champion policies that promote innovation, affordability, and self-reliance in medicines, has expressed strong support for the Food and Drug Administration’s (FDA) efforts to institutionalize a “Green Lane” to accelerate regulatory processes for health establishments and products covered under the government’s Strategic Investment Priority Plan, Tatak Pinoy enterprises, and other national development priorities. PCPI is the biggest association of local pharmaceutical companies, with a membership of about 90 companies, including Unilab Inc., the country’s largest pharmaceutical manufacturer.

Under the leadership of FDA Director General Atty. Paolo S. Teston, the Green Lane initiative seeks 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 fully upholding the FDA’s rigorous standards of safety, quality, and efficacy.

PCPI has actively supported the expansion of the Green Lane through sustained policy dialogues, public-private partnerships, and regulatory engagements with the FDA, the Department of Health, the Anti-Red Tape Authority, and other key stakeholders.

“PCPI strongly applauds the FDA’s proactive regulatory reforms, which strike a balance between efficiency and unwavering safety standards,” said Dr. Lloyd Balajadia, president of PCPI. “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.”

According to Dr. Balajadia, the Green Lane marks a significant step toward strengthening the Philippine pharmaceutical industry and building a more resilient, 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.

PCPI noted that local pharmaceutical companies play a crucial role in maintaining a stable medicine supply, particularly during public health emergencies. The COVID-19 pandemic, global supply chain disruptions, and ongoing geopolitical tensions have underscored the risks of over-reliance on imported medicines and active pharmaceutical ingredients (APIs).

“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 highlighted the Green Lane’s strong alignment with national priorities under the Universal Health Care Law and the Philippine Pharmaceutical Industry Roadmap. By encouraging investment in local manufacturing, the initiative supports broader government goals of reducing import dependence, enhancing national health security, promoting sustainable industrial growth, and generating quality employment.

PCPI expressed appreciation for the current FDA leadership’s understanding of the realities and capabilities of the domestic pharmaceutical sector, noting that local manufacturers possess the technical expertise to produce a wide range of medicines. The Green Lane initiative, the group said, will further position the Philippines as a competitive pharmaceutical manufacturing hub in the region.

PCPI urged the swift finalization of the Green Lane guidelines through continued consultations and active stakeholder engagement, building on ongoing collaborative efforts to advance regulatory reforms that benefit both public health and industry development.