Philippines Food and Drug Administration (Philippines FDA)

1. Overview

The Philippines Food and Drug Administration operates as a regulatory body within the Filipino government’s Department of Health. Its primary responsibility is to ensure the safety, efficacy, and quality of various health products including, drugs, medical devices, food, cosmetics, biologicals, vaccines, in-vitro diagnostic reagents, etc. This mandate also extends to consumer products that may impact consumers’ health.

2. Philippines FDA Medical Device Registration

Manufacturers of Medical Devices are prohibited from importing, exporting, manufacturing, distributing, or marketing their products in the Philippines without prior notification or registration with the Filipino FDA.

The classification of devices in the Philippines is as follows.

For Class A devices, notification is required, leading to the issuance of the Certificate of Medical Device Notification (CMDN). On the other hand, Class B, C, and D devices must undergo registration with the Filipino FDA. Subsequent to this registration, the Certificate of Medical Device Registration (CMDR) will be provided.

Two essential documents are necessary for medical device registration in the Philippines – License to Operate (LTO) and a registration certificate.

Any healthcare-related establishment in the Philippines can apply for the LTO, provided they are engaged in activities such as importing, distributing, wholesaling, manufacturing, trading, etc., within the healthcare sector.

Required documents for obtaining an LTO for a medical device importer/distributor include:

• Business Registration Certificate
• Location Plan
• Contract of Lease for the Space
• Pharmacist Information
• Product Listing
• Floor Plan
• Agreement with the Medical Device Manufacturer for Distribution

The time frame for obtaining the LTO typically ranges from 1 to 3 months.

Once a company possesses an LTO, it can proceed to apply for the registration certificate. The essential documents needed to obtain the medical device registration certificate in the Philippines include:

1. ISO 13485
2. Free Sale Certificate from the Country of Origin
3. Device Description, Features, Indications
4. Instructions for Use
5. Pre-clinical Studies
6. Clinical Studies
7. Shelf Life and Biocompatibility
8. Label
9. Risk Analysis
10. Manufacturing Process

3. Philippines FDA Pharmaceutical Registration

New Drug Products can enter the Philippines through either an Abridged Review or a Verification Review.

The abridged review entails a limited independent assessment of specific sections of the dossier or submission, evaluating its suitability for use under local conditions and regulatory requirements. This is contingent on a prior assessment by a Reference Drug Regulatory Authority (RDRA). There are 14 RDRAs, including the U.S. FDA, the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and Health Canada, among others. This option is available when the RDRA has previously approved the drug product, vaccine, or biological, within 3 years from its approval date.

In the verification review process, the company submits an evaluation that has been approved by at least 2 RDRAs. The local Filipino FDA then validates the submission, ensuring its alignment with the Filipino drug registration requirements approved by the RDRAs.

The documentary requirements for new drugs, vaccines, and biologicals include:

1. Formal request from the applicant
2. Evaluation report from the RDRA/s
3. Valid Certificate of Pharmaceutical Product (CPP)
4. ICH Common Technical Document (CTD) or ASEAN Common Technical Dossier (ACTD) data.
5. Stability studies
6. Proposed Package insert

The Abridged Review and Verification Review processes are expected to have approval times of around 45 working days and 30 working days, respectively.