PCPI, the country’s largest association of Filipino-owned pharmaceutical companies, explained in a press statement that the initiative will accelerate approvals for manufacturers covered under the government’s Strategic Investment Priority Plan, Tatak Pinoy enterprises, and other priority programs—while maintaining strict standards for safety, quality, and efficacy.
With about 90 member companies, including industry giant Unilab Inc., PCPI said the Green Lane is a critical reform that recognizes the role of local manufacturers in ensuring timely access to essential medicines.
Prioritizing local manufacturers
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 pharmaceutical manufacturers, particularly those producing essential and critical medicines.
The proposed framework includes streamlined review timelines, clearer documentation requirements, and closer coordination between regulators and manufacturers, without compromising regulatory rigor.
PCPI said it 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 (DOH), the Anti-Red Tape Authority (ARTA), and other stakeholders.
Boost to jobs, access to medicines
“PCPI strongly applauds the FDA’s proactive regulatory reforms, which strike a balance between efficiency and unwavering safety standards,” said PCPI president Dr. Lloyd Balajadia.
He said the initiative is expected to generate economic value, create jobs, and enable faster delivery of life-saving medicines to patients.
“This draws from proven regulatory models in countries such as Singapore, India, and China,” Balajadia added.
According to PCPI, institutionalizing the Green Lane is a significant step toward strengthening the domestic pharmaceutical industry and building a more resilient, self-reliant medicines supply chain.
Lessons from recent crises
PCPI underscored the importance of local pharmaceutical manufacturing in maintaining a stable medicine supply, particularly during public health emergencies.
The COVID-19 pandemic, global supply chain disruptions, and ongoing geopolitical tensions, the group said, have exposed 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.”
Aligned with national priorities
The chamber noted that the Green Lane initiative is aligned with the Universal Health Care Law and the Philippine Pharmaceutical Industry Roadmap, which aim to reduce import dependence, enhance national health security, promote sustainable industrial growth, and generate quality employment. —Ed: Corrie S. Narisma
