Navigating Pharmaceutical Regulations in the Philippines: Trends, Challenges, and Registration Process

 

The medical device market in the Philippines is undergoing significant changes driven by regulatory updates, market demands, and the ongoing impact of the COVID-19 pandemic. This article delves into the current landscape, key drivers, and future outlook of the medical device industry in the Philippines, drawing insights from the 19th Government Affairs and Regulatory Affairs (GARA) conference held in 2023.

 

Pharmaceutical Landscape in the Philippines

In 2024, the projected revenue in the Philippine pharmaceutical market is expected to reach USD 2.68 billion. Approximately 90% of sales are supplied through retail outlets, primarily pharmacies, with the remaining coming from hospitals. Pharmaceutical products in the Philippines are largely imported from the United States, India, and Germany. Ethical products or prescription drugs account for about 70% of the market, followed by over-the-counter medicines.

 

 

Drug Category with Top Demands

 The largest market within this market is Oncology Drugs, with a projected market volume of US$274.60M in 2024. Looking ahead, the revenue is expected to exhibit an annual growth rate (CAGR 2024-2029) of 2.39%, resulting in a market volume of US$2.327B by 2029.

 

Market Growth and Opportunities

The Philippine medical device market is expected to grow at a compound annual growth rate (CAGR) of 9% in Peso terms, reaching $884.3 million by the end of 2024. This growth is driven by the modernization of hospitals, rising prevalence of chronic diseases, and significant government funding for healthcare infrastructure. The Department of Health (DOH) has allocated over PHP 23 billion for the Health Facilities Enhancement Program (HFEP) in 2023, aiming to upgrade health facilities and services across the country.

 

Key Market Drivers

1. Healthcare Infrastructure Development: The demand for medical devices is primarily driven by private hospitals expanding through the acquisition of existing facilities and construction of new ones. There is a significant need for diagnostic imaging products, cardiac devices, dialysis machines, and other specialized equipment.
2. COVID-19 Impact: The pandemic has led to a behavioral shift, increasing the usage of surgical masks, gloves, and other consumables. This has positively impacted the consumables market, with a surge in demand for personal protective equipment (PPE) and diagnostic machines such as RT-PCR machines.
3. Aging Population: The elderly population in the Philippines is expected to reach 5.6% by 2025 and 6.3% by 2030, driving the need for medical devices catering to chronic conditions associated with aging.

Future Projections

The future outlook for the Philippine medical device market is promising, with anticipated growth in various segments. The share of distributors in the equipment market is expected to increase to 46.5% by 2025. Key segments poised for growth include diagnostic equipment, dialysis devices, cancer therapy equipment, and hospital furniture. The implementation of Universal Health Care by the government will further support market expansion, ensuring broader access to medical services and devices.

 

Key Segments Covered

1. Diagnostic Equipment: With the rising prevalence of chronic diseases and the need for early detection, diagnostic equipment remains a critical segment. Innovations in imaging technologies and portable diagnostic devices are expected to drive growth.
2. Dialysis Devices: The increasing incidence of kidney diseases necessitates advanced dialysis devices, which are essential for improving patient outcomes and quality of life.
3. Cancer Therapy Equipment: The growing cancer burden in the Philippines highlights the need for state-of-the-art cancer therapy equipment. This includes radiotherapy machines, chemotherapy delivery systems, and supportive care devices.
4. Hospital Furniture: The ongoing expansion and modernization of healthcare facilities require high-quality hospital furniture that meets the evolving needs of patients and healthcare providers.

 

Philippines Ophthalmology Market

The ophthalmology market in the Philippines is another promising segment, driven by increasing cases of eye diseases and conditions such as cataracts, glaucoma, and diabetic retinopathy. The demand for advanced ophthalmic devices, including diagnostic instruments, surgical equipment, and vision care products, is rising. Government initiatives to combat preventable blindness and improve eye care accessibility are further boosting this market.

 

Regulatory Landscape and Challenges

The Philippine Food and Drug Administration (FDA) has been implementing the ASEAN Medical Device Directive (AMDD), which has introduced new regulations and processes for medical device registration. The transition to AMDD has posed several challenges, including bottlenecks due to understaffed FDA centers and confusion over product classification. The FDA has also moved from face-to-face to online submissions, limiting the number of product applications per company per day, and implemented new timelines and fees for different classes of medical devices.

 

Transition Period of AMDD Adaptation (2024)

The adaptation of the AMDD has created several bottlenecks and challenges for registrants. One of the major issues is the understaffing of FDA centers, which has led to delays in the processing and approval of medical device applications. Additionally, there has been significant confusion and the issuance of numerous Notices of Deficiency (NOD) primarily due to issues with product groupings. The complexity of grouping products correctly under the new AMDD guidelines has been a major cause of delays and rejections.

 

Current Regulatory Updates with Significant Impact on the Industry

Recent regulatory updates have had a significant impact on the medical device industry. These include the enforcement of stricter timelines for submission and approval processes, increased fees for registration, and the requirement for more comprehensive documentation. These updates aim to ensure higher standards of safety and efficacy but have also added to the regulatory burden on companies.

 

New Implementation for Upcoming Year (2024)

Looking ahead, several new implementations are expected to take effect in 2024. These include further refinements to the AMDD guidelines, introduction of new submission portals for better tracking and management of applications, and stricter enforcement of compliance measures. These changes are designed to streamline the registration process and improve regulatory oversight, but they will require companies to stay abreast of the latest requirements and adjust their compliance strategies accordingly.

FDA Drug & Food Regulation in the Philippines

1. Drugs Regulatory Process Flow: The process for drug regulation in the Philippines involves several steps, including pre-submission preparation, submission of applications, evaluation, and approval. The FDA evaluates the safety, efficacy, and quality of drugs before granting approval.
2. Drugs Foreign GMP Clearance: For foreign-manufactured drugs, obtaining Good Manufacturing Practice (GMP) clearance is mandatory. The FDA requires comprehensive documentation and evidence of GMP compliance from the manufacturing site. This process ensures that imported drugs meet the same high standards as locally produced ones.
3. Food Regulatory Process Flow: The regulatory process for food products involves registration, compliance with labeling and safety standards, and regular inspections. The FDA ensures that food products are safe for consumption and properly labeled to inform consumers.

The process takes approximately 12 months, depending on the product category being registered. Registration fees vary from USD 113 for generic drugs to USD 583 for new chemical entities.

 

Philippines Government Bidding

The Philippine government conducts public bidding for the procurement of pharmaceutical products to ensure transparency, competitiveness, and cost-effectiveness. Key points include:

• Public Bidding Process: Companies must participate in the bidding process for government contracts, which includes the submission of proposals and compliance with specific requirements.
• Evaluation Criteria: Bids are evaluated based on factors such as cost, quality, and supplier capability.
• Contract Awards: Successful bidders are awarded contracts to supply pharmaceutical products to government healthcare facilities.

MAJOR REQUIREMENTS:

1. Local Representative (Filipino)
2. Business Registration (SEC)
3. Business Permits (Mayor’s Permit)
4. Audited Financial Statement
5. Tax Clearance Certificate

 

Philippines Drug Regulation (Foreign GMP Evidence Evaluation)

The Philippines FDA requires foreign pharmaceutical manufacturers to provide evidence of Good Manufacturing Practice (GMP) compliance as part of the drug registration process. This evaluation includes:

• GMP Certificates: Submission of valid GMP certificates from recognized regulatory authorities.
• Site Inspections: FDA may conduct site inspections or accept inspection reports from trusted international agencies.
• Quality Assurance: Ensuring that manufacturing processes meet international standards for safety, efficacy, and quality.

For Foreign GMP Evidence Evaluation

1. Letter of Request
2. GMP Evidence
3. Annex B – Request for GMP Evidence Evaluation Form
4. Annex E – Affidavit of Undertaking
5. Assessment Slip

 

Strategies for Quick Market Entry

For companies looking to enter or expand in the Philippine medical device market, understanding the regulatory environment is crucial. Partnering with local representatives who are well-versed in the FDA’s requirements and the AMDD guidelines can streamline the registration process. Additionally, investing in market research to identify high-demand segments and aligning with government initiatives like the HFEP can provide competitive advantages.

 

Why Choose Mursmedic Philippines?

Mursmedic Philippines offers comprehensive services to facilitate the entry and growth of pharmaceutical companies in the Philippine market:

• End-to-End Regulatory Support: Assistance with the entire regulatory process, from document preparation to FDA submissions.
• Logistics and Distribution: Efficient logistics and distribution solutions to ensure timely market access.
• Market Insights and Strategy: In-depth market analysis and strategic planning to optimize market entry and growth.
• Local Expertise: A team of local experts with extensive knowledge of the Philippine pharmaceutical landscape and regulatory environment.

 

Conclusion

 

The pharmaceutical market in the Philippines offers significant opportunities for global pharmaceutical companies. By understanding local regulations, market trends, and existing challenges, companies can optimize their entry strategies and achieve success in this growing market. Mursmedic Group is ready to assist with end-to-end services to facilitate registration, logistics, and inventory management for pharmaceutical companies aiming to operate in the Philippines.