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Lifesciences Compliance Services in Philippines
Philippine market provides huge opportunities for enhancement of Lifesciences products. This facilitates manufacturers of Lifesciences product to thrive and expand with excellence in Philippines market.
Philippines
Artixio as the trusted regulatory partner in Philippines helps in 100% regulatory compliance with the FDA Philippines. We focus on resolving regulatory concerns directly with the FDA Philippines for a hassle-free product approval and seamless regulatory process. Over the years we have supported products in Philippines with our experienced local professional in Philippines. We are committed in providing remarkable services to navigate through the challenges in Philippine compliance.
Regulatory Authorities in Philippines
The main regulatory authority governing in Philippines is the Food and Drug Administration (FDA) Philippines which was earlier known as the Bureau of Foods and Drugs. The FDA Philippines works under the Department of Health. Some other regulatory authorities are working too, such as Hong Kong’s Centre for Food Safety (CFS) which operates under the Hong Kong Food and Environmental Hygiene Department (FEHD) for regulation of beauty products and cosmetics, and the Bureau of Animal Industry (BAI) under the Philippine Department of Agriculture which regulates animal care and veterinary products.
The following table depicts the regulatory bodies responsible for which category of products:
| Industry | Regulatory Body | Responsibilities |
|---|---|---|
| Pharmaceuticals | FDA (Philippines) | Grants drug approval and market access. Ensures safety and efficacy of drug. |
| Medical Devices | FDA (Philippines) | Regulates the Medical devices in the Philippian market. |
| Wellness products | CFS | Confirms the quality and ensures the safety and efficacy of wellness products. |
| Cosmetics | FDA (Philippines) | Ensures the quality, standards, purity of cosmetics in Philippian market. |
| Animal care and Veterinary products | BAI | Regulates the veterinary products in the Philippian market by confirming its safety, efficacy and quality. |
Ensure Seamless Regulatory Compliance in Philippines with Artixio
We provide end-to-end support to make your product reach heights of success in Philippines. We have a specialized team with local expertise that provides support for pharmaceuticals, medical devices, wellness products, animal care and veterinary products. We closely work with the FDA Philippines to address compliance doubts and queries, to guarantee a smooth hassle-free regulatory process that ultimately leads to a speedy product approval.
Service Category
- Regulatory Affairs
- Market access
- Pharmaco-vigilance
- Quality Assurance
Pre-registration services
- Regulatory Intelligence
- Market assessment
- Technical and medical writing
- Local Agent Appointment
- Document Review
- Risk Management
- Pre-submission to FDA (Philippines)
- IND
- NDA
- Dossier Gap Analysis
- Technical Due Diligence
Registration services
- Product registration in Philippines
- Submission of registered documents
- to FDA (Philippines)
- HA liaison and legal
- Medical and Technical Writing
- Labelling and Artwork
- ECTD/CTD preparation and submission to FDA (Philippines)
- Compliance check
Post-registration services
- Compliance monitoring
- Post-marketing surveillance in Philippines
- Product Recall Management
- Lifecycle Maintenace
- Line extensions
- Importer/ Distributer Assistance in Philippines
Why Artixio?
Successful approvals and ongoing product lifecycle maintenance for 200+ products.
Diverse products experience across complex products categories and therapeutic areas.
Strong regional expertise, experts with 15-35 years of experience.
Proven experience in end-to-end product value chain from concept to commercialization.
TFDA experience in navigating through complex, often ambiguous regulations.
Intelligence driven, global regulatory services supported by Dvarka.
ISO 9001:2015 quality standards governed services.
Customer focused, flexible services and solutions.
Flexible business model including project based, managed services and FTE staffing model.
Hybrid-Local-Centralized support across all PMDA functions.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Industries We Serve in the Philippines
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
Which is the reference drug authority in the Philippines?
The Philippine FDA is the main drug authority in Philippine who oversees the approval and ensures the safety, efficacy and quality of pharmaceuticals, cosmetics and medical devices. However, the animal care and veterinary products industry is overlooked by BAI while the wellness products are administered by CFS in Philippine.
These authorities ensure the smooth working of regulations by the pharmaceuticals, medical devices, wellness products, animal care and veterinary industries.
How do we manage adverse drug reporting with regulatory authorities in the Philippine?
The adverse drug reporting in Philippine is regulated by the Philippine FDA’s Centre for Drug Regulation and Research (CDRR). It has its online portal for reporting of adverse drug reactions known as the MedWatch program. The FDA’s form number 1576 is specifically designed for ADR reporting. It should be filled out electronically and submitted online or through email.
What is the fees structure for pharmaceuticals, medical devices, wellness products, animal care and veterinary products in the Philippine FDA?
The fee’s structure varies from product to product depending upon the product and its category. Generally, the fees range from 10k-50k for pharmaceuticals, 5k-40k for medical devices.5k-10k for cosmetics, wellness products and animal care products.
What is the general timeline for regulatory approval for pharmaceuticals, medical devices, wellness products, animal care and veterinary products
The general timeline for the regulatory approval for pharmaceuticals, medical devices, wellness products, animal care and veterinary products is generally from few months to a year depending upon the product complexity such as pharmaceuticals may take longer time than nutraceuticals for their approval.
What is the process for foreign manufacturers to launch their product in the Philippine market?
The foreign manufacturers need to appoint a local representative in the Philippine market for their products approval. The local agents are generally known as Authorized Representative (AR). The foreign manufacturer needs to submit carry the complete process through the AR. The AR is responsible for the filing the product approval application, submitting the necessary documents, ensuring regulatory compliance of the product, etc. He is also held responsible for the safety monitoring of the product after its approval.
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