The Philippine Chamber of the Pharmaceutical Industry (PCPI), a major industry group of Filipino-owned pharmaceutical companies, vowed to work closely with the Food and Drug Administration (FDA) and the Anti Red Tape Authority (ARTA) to further improve the competitiveness of the domestic industry. 

At the induction ceremony of the 2024 PCPI directors and officers, the group’s new president Dr. Lloyd Balajadia said they will push for the competitiveness of their industry. 
 

“We at the Philippine Chamber of the Pharmaceutical Industry (PCPI)  look forward to working together with FDA and ARTA to achieve our vision of a globally competitive and sustainable Philippine pharmaceutical industry that provides Filipinos with high-quality and affordable medicines,” said Balajadia. 
 

PCPI was founded in March 2004 by merging the Chamber of Filipino Drug Manufacturers and Distributors, Inc., the Association of Drug Industries of the Philippines, the Filipino Drug Association, and the Association of Philippine Pharmaceutical Manufacturers.
 

For its part, ARTA Secretary Ernesto V. Perez reiterated his commitment to support local pharmaceutical companies by working closely with the FDA and the Department of Health (DOH) to streamline and expedite processes. 
 

“Our aim is to leverage our collective strengths to pave the way for the rise of a Bagong Pilipinas. We are confident that through our unified efforts with FDA and PCPI, we can continue to empower the Philippine pharmaceutical industry to grow and contribute to the local economy,” said Perez. 
 

DA Director-General Dr. Zacate emphasized his goal of ensuring that FDA policies enable and empower the local pharmaceutical industry. “We at FDA are committed to supporting PCPI and the local pharmaceutical companies by ensuring that FDA policies are updated to meet the local pharmaceutical industry needs and that industry-related processes are accessible and efficient,” said Zacate. 
 

The newly inducted officers and board of directors comprise of representatives from Filipino-owned pharmaceutical companies. 
Recently, ARTA and ARTA held a Kapihan Session to address streamlining concerns and discuss ways to improve processes in compliance with the Ease of Doing Business law.

Perez emphasized the law’s intent to cut processing time and costs in the drug and pharma industry.

The concerns discussed during the Kapihan include long processing time for assessments of FDA applications, lack of uniform assessment standards, and e-portal glitches, among others.

On the issues of the slow processing time for assessment of FDA applications, whether new or renewal, and lack of uniform assessment or evaluation, Zacate said that the FDA plans to deputize evaluating bodies from external service providers.

To this, Perez recommended the creation of guidelines on the processes to create uniformed rules in the assessment of these applications apart from updating its Citizen’s Charter. FDA will also be looking into other causes of backlogs in the processes of registrations in the FDA such as the possibility of communication gaps not just between the FDA and its stakeholders but also within the stakeholders themselves.

Another issue raised during the Kapihan was the unresponsiveness of the FDA email and the lack of face-to-face consultation with the FDA, Zacate explained that many of the emails go to their other emails but their active email is the [email protected] email. In response, ARTA recommended FDA to employ strategies to improve email responsiveness, as well as the upgrade system to indicate the status of applications and closely coordinate with concerned stakeholders.

While admitting that there is a current backlog in the FDA’s e-portal, Zacate committed to improving and upgrading the FDA’s e-portal system and update ARTA on its ongoing efforts in relation to this. ARTA recommended that the FDA form partnerships with payment gateways in the country while opening an over-the-counter payment by this month to immediately address this concern.

Other issues raised include the repeal of Administrative Order (AO) 67 or the Revised Rules and Regulations on Registration of Pharmaceutical Products. ARTA recommended the possible harmonization of the amendment on AO 67 and proposed revision of fees and charges. Another one is the non-issuance by FDA of Good Manufacturing Practice (GMP) clearances, inspection schedules, and the Permit to Register (PTR) which were already 50 percent paid in advance. In response to this, the FDA committed to refer the complaint to the appropriate office and update ARTA on the progress of the complaint.