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

The Philippine Chamber of Pharmaceutical Industry (PCPI), which unites Filipino-owned pharmaceutical corporations 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 speed up regulatory processes for health establishments and products covered under the federal government’s Strategic Investment Priority Plan, Tatak Pinoy enterprises, and other national development priorities. PCPI is the largest association of local pharmaceutical corporations, with a membership of about 90 corporations, 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 ascertain a regulatory pathway that prioritizes applications from qualified local manufacturers, particularly those producing essential and significant medicines. The framework is designed to supply 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 comparable to Singapore, India, and China.”

In line with Dr. Balajadia, the Green Lane marks a major step toward strengthening the Philippine pharmaceutical industry and constructing a more resilient, self-reliant medicines supply chain. “It recognizes the critical role of local manufacturers in ensuring the regular availability of reasonably priced, high-quality medicines for Filipino patients,” he added.

PCPI noted that local pharmaceutical corporations play an important 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 energetic pharmaceutical ingredients (APIs).

“Local manufacturers are sometimes the primary to answer 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 present FDA leadership’s understanding of the realities and capabilities of the domestic pharmaceutical sector, noting that local manufacturers possess the technical expertise to supply a wide selection of medicines. The Green Lane initiative, the group said, will further position the Philippines as a competitive pharmaceutical manufacturing hub within the region.

PCPI urged the swift finalization of the Green Lane guidelines through continued consultations and energetic stakeholder engagement, constructing on ongoing collaborative efforts to advance regulatory reforms that profit each public health and industry development.

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