The Philippines – Regulatory Affairs
Within the ASEAN region, the Philippines is the third most attractive Pharma market. Overall, the Filipino Pharma market is still relatively dependent on foreign manufacturers, meaning that there is plenty of opportunity for foreign companies seeking to enter this growing market.
Regulatory Body - Food and Drug Administration of the Philippines
The regulatory bodies in the Philippines responsible for the registrations of drug products and medical devices is called the Food and Drug Administration of the Philippines (FDA).
Pharma Prescription Drugs
To be distributed in the Philippines, companies must first obtain a license to operate and a certificate of product registration from the FDA. After obtaining a license to operate, companies must apply for a certificate of product registration to have their products examined and registered with the FDA. However, the requirements for application for the certificate of product registration vary depending on the status of the product as a new drug or a generic.
Consumer Healthcare Drugs/OTC
OTC drugs and prescription drugs for distribution are subject to similar registration processes. Companies must still receive a licence to operate before applying for a certificate of product registration. However, for many OTC preparations and household remedy products, the application dossier is amended and much shorter than for prescription drugs. With our long-term experience and network with the DAV, we can offer a relatively fast registration process for Consumer Healthcare & OTC drugs in the Philippines.
Medical Devices
In the Philippines, medical devices are divided into four type – Classes A, B, C, and D based on their level of risk. The rules for device classifications are quite specific and can vary greatly depending on different criteria. All medical devices imported into the Philippines are required to register for a Certificate of Medical Device Notification (CMDN) if they are Class A devices, or a Certificate of Medical Device Registration (CMDR) if they are Class B to D. The registration processes for obtaining the certificate vary depending on the class of the medical device.
Food Supplements/Nutraceuticals
Food supplements and nutraceuticals in the Philippines are regulated by the FDA. All companies seeking to import and manufacture food products including supplements in the Philippines must first obtain a License to Operate (LTO). For importers, they must have a certificate of distributorship and must also have accurate stability and safety data.
Cosmetics and Derma
Similar to other medical devices or drug products, all cosmetic companies in the Philippines must obtain a License to Operate from the FDA prior to engaging in manufacturing, importing, distribution and sale of cosmetics. Unlike other medical products, cosmetics only require an application for a Notification of Cosmetic Product from the FDA, which is simpler than applications for the Certificate of Product Registration.
Photo by Mara Rivera on Unsplash
Frequently Asked Questions from clients – Regulatory Affairs
- FAQ - Prescription Products
- FAQ - OTC Products
- FAQ - Medical Devices
- FAQ - FS and Neutraceuticals
- FAQ - Cosmetics and Derma
- Will my existing BE studies be accepted in the Philippines?
- What are the important things to take understand with regards to
trademarks by the FDA? - Can my home company act as a MAH in the Philippines?
- What is the difference in climate zone for stability studies in the Philippines vs. Europe and Latin America?
- Is the fast track registration process possible for my products in the Philippines and what to be aware of?
- What are the pharma/prescription drug registration costs and time in the Philippines?
- How many trademarks should be suggested to the FDA and why?
- How can my own company be MAH in the Philippines for my products?
- What are the Consumer Healthcare Drugs/OTC registration costs and time in the Philippines?
- How to register Herbal and Phyto OTC drugs through FDA via fast track process and why to prepare the market entry strategy before?
- What do I need to know about climate zone for stability studies in the Philippines?
- Is a fast track registration process available in the Philippines and what to make sure of?
- What is the difference between Medical Device registration and definition in the Philippines vs. Europe, North America and throughout Latin America?
- Is my product considered a Medical Device by the laws of the FDA?
- What are the important differences in trademark registration in the Philippines with regards to the FDA for Medical Devices?
- Are local clinical trials necessary in the Philippines?
- Can my company act as a MAH in the Philippines?
- Climate zone for stability studies in the Philippines
- Is a fast track registration process available in the Philippines and what to be aware of?
- How difficult is the registration of Medical Devices in the Philippines?
- What are the Medical Devices registration costs and time in the Philippines?
- To which class of Medical Devices does my product belong?
- How to register claims on the pack for Food Supplements in the Philippines with the FDA?
- Why trademark registration in the Philippines can be a very difficult task with the FDA?
- Can my company act as a MAH in the Philippines for Food Supplements?
- What Climate zone for stability studies do I need for Food Supplements in the Philippines?
- How difficult is the registration of Food Supplements/Nutraceuticals in the Philippines?
- What are the Food Supplements/Nutraceuticals registration costs and time in the Philippines?
- How to register claims in the Philippines for Cosmetics with the FDA?
- Why is the trademark registration for Cosmetics and Derma products a big topic in the Philippines?
- Can my company act as a MAH in the Philippines or do I need a local partner for registration?
- What are the important topics about climate zone for stability studies in the Philippines?
- How difficult is the registration of Cosmetics in the Philippines?
- What are the Cosmetics registration costs and time in the Philippines?