4. Supply of Ingredients

Ingredients Regulation Overview for Ingredient Manufacturers
Philippines

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

All substances, whether active or excipients, employed in processing a finished drug product are defined as raw materials.

4.1.1 Registration requirements

Currently, there are no registration requirements for raw materials used in drug manufacture as their quality and safety are assessed as part of a drug product registration process.

However, a new Administrative Order “Rule and Regulations on the Issuance of Authorization for Registration Applications of Drug Products and Drug Substances by the Food and Drug Administration”, the draft of which was released for comment, will likely introduce the requirement for drug substances to be registered with the FDA:

“For drug substances, the registration application shall be for FDA authorization to allow the production and marketing of the drug substance as a raw material to other pharmaceutical companies. Through the approval of the application, it is ensured that the drug substance is of good quality for use in the manufacture of drug products.”

The draft closed for comment in July 2023, but the order is not yet in force.

4.1.2 Importation

4.1.2.1 Overview of Process

For a foreign manufacturer to supply drug substances in the Philippines, they must authorize a local company holding a License to Operate (LTO) as a Drug Distributor (Importer/Exporter/Wholesaler) to perform the importation. The nominated qualified person of the LTO must be a registered pharmacist. Appointment of an LTO holder requires a Foreign Agency Agreement from the ingredient supplier and provision of their GMP Certificate from the regulatory authority of the country of manufacture.

The LTO holder (or their authorized customs broker/agent) lodges the goods declaration with the Bureau of Customs for the imported products.

New guidelines that have been circulated for comment (“Guidelines for the Importation and Exportation of Finished Drug Products and Raw Materials”) aim to strengthen market control within the distribution chain. If these are implemented, raw materials will require a Clearance for Customs Release (CFCR) from the FDA prior to importation.

4.1.2.2 Documents Required from the Ingredient Supplier

Currently, only the Licence to Operate is required to be presented for the importation of raw materials for drug manufacturing (FDA Memorandum Circular 2013-032), therefore no documents from the ingredient supplier are required.

If the new guidelines are implemented, the ingredient supplier will be required to provide GMP Certification and a Certificate of Analysis for the customs clearance of the imported products.

4.1.3 Change Notification

A change to the API trade name would have no regulatory impact as currently raw materials are not registered with the FDA.

4.2 In Pharmaceutical Products Produced by Filipino Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration requirements

A Certificate of Product Registration must be obtained before the product can be supplied in the Philippines. A LTO is required to make an application for a CPR.

4.2.1.2 Registration Procedure

The LTO holder makes the application for the drug product registration through the eServices Portal (https://eservices.fda.gov.ph/).

The application includes completion of the application form and provision of the documentation relevant to the type of application.

4.2.1.3 Documents to be Provided by Ingredient Supplier

For New Chemical Entities/Generic Prescription Drug Registrations

Documents required depend on the submission procedure for the Part II: Quality- Drug Substance (S) section of the dossier. There are three options available for submission of the required information:

Over the Counter Drug Registration

1. Certificate of Analysis of active raw material(s) from both ingredient supplier and manufacturer of finished product
2. Technical specifications for all raw materials must be included

4.2.1.4 Cost and Timelines

Note: Fees indicated in Philippine peso (1 PHP = approx. 0.016 EUR or 0.017 USD)

4.2.1.5 Renewal Frequency and Cost

An initial registration is valid for three years, although an annual fee is payable for some product classifications. Renewal of registration after this initial term is for a five-year period, with the renewal fee costing 70% of the initial application fee.

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

Change notification is in line with the ASEAN Variation Guideline for Pharmaceutical Products. A change to the API trade name does not meet the requirements for notification to the Philippines FDA, therefore, no regulatory action would be required.

4.3 As Active Substances for Health Supplements (B2B)

4.3.1 Registration

4.3.1.1 Registration Requirements

Before the ingredients can be supplied to the Philippines, they require a Certificate of Product Registration (CPR). The application for a CPR must be made by an importer/distributor with a License to Operate (LTO), which can only be obtained by a Filipino company.

Once a raw material has been registered, it is listed in the FDA Verification Portal, an online database of establishments with a Licence to Operate, and health products with a Certificate of Product Registration (https://verification.fda.gov.ph/Home.php).

If raw materials are imported by an FDA-licensed food establishment for their own use in manufacture, a Certificate of Product Registration is not required. However, the establishment must hold a LTO as an importer and the sources of the raw materials should be notified to the FDA.

4.3.1.2 Registration Procedure

1. Ingredient supplier appoints a local Importer/Distributor with a LTO
2. LTO holder makes the application for Certificate of Product Registration through the electronic registration system by completing the application form and submitting the relevant documentation

4.3.1.3 Documents Required from Ingredient Supplier

1. Clear and complete loose labels or artwork of all packaging sizes, reflecting all sides of the packaging
2. Picture of the product from all angles and in different packing sizes and from at least two different perspectives allowing visual recognition of a product as the same as the one being registered
3. Certification to support the use of logo/seal on Sangkap Pinoy, Halal, Organic, or Kosher food
4. Evidence of agreement between the supplier and appointed distributor in the form of one of the following:
   1. Foreign Agency Agreement
   2. Certificate of Distributorship
   3. Appointment letter
   4. Memorandum of Agreement
5. Evidence of manufacturing quality compliance in the form of:
   1. Certificate of Registration with GMP Compliance
   2. Valid Phytosanitary or Health Certificate
   3. Valid ISO 22000 Certificate
   4. Valid FSSC Certificate
   5. Valid HACCP Certificate
   6. Certificate of Free Sale issued by the regulatory/health authority which must declare that the product is fit for human consumption and/or is freely sold from the country of origin
6. Function of the ingredient - specifications and product information

4.3.1.4 Cost and Timelines

Note: Fees indicated in Philippine peso (1 PHP = approx. 0.016 EUR or 0.017 USD)

4.3.1.5 Renewal Frequency and Cost

See the above table.

4.3.2 Importation

4.3.2.1 Overview of Process

As per the process for Drug Substances, the qualified person of the LTO holder is not required to be a pharmacist. Instead, they must be the company regulatory officer/food safety compliance officer with a qualification in food safety, GMP, or HACCP from a relevant industry/professional organization.

4.3.2.2 Documents Required from the Ingredient Supplier

The LTO and CPR are required to be presented for the importation of raw materials for health supplement manufacturing, therefore no documents from the ingredient supplier are required.

If the raw material is imported by an FDA-licensed manufacturer for their own use, only an LTO is required.

4.3.3 Change Notification

A change to the API trade name would require an amendment to the Certificate of Product Registration. The amendment would be made by the LTO holder and would require the provision of the new labels and authority from the ingredient supplier. Submission of the amendment incurs a fee of 2,500 PHP.

4.4 In Health Supplements Produced by Filipino Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

Health supplements containing vitamins and minerals are classified as medium-risk products. A Certificate of Product Registration is required before they can be supplied. The application for the CPR must be made by a distributor (wholesaler/trader) with a LTO.

4.4.1.2 Registration Procedure

1. The local manufacturer appoints a distributor with an LTO (or holds their own LTO as a distributor).
2. The distributor makes the application for a Certificate of Product Registration through the electronic registration system by completing the application form and submitting the relevant documentation.

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

No documents are required from the ingredient supplier to support the registration.

4.4.1.4 Cost and Timelines

Note: Fees indicated in Philippine peso (1 PHP = approx. 0.016 EUR or 0.017 USD)

4.4.1.5 Renewal Frequency and Cost

See the above table.

4.4.2 Importation

Not applicable to locally manufactured products.

4.4.3 Change Notification

Since no documentation is required from the ingredient supplier for registration, a change to the active substance brand name would have no regulatory impact.

4.5 As Ingredients for Veterinary Products (B2B)

4.5.1 Registration

Raw materials used for manufacturing veterinary drugs are not required to be registered.

4.5.2 Importation

In accordance with the FDA Advisory No. 2022-0591, the process for importation is the same as for raw materials used in the manufacture of human drugs. Only a valid Licence to Operate is required to be presented at the Bureau of Customs for immediate release, therefore no documentation is required from the ingredient manufacturer.

4.5.3 Change Notification

A change to the API trade name would have no regulatory impact as raw materials are not registered with the FDA.

4.6 In Veterinary Product Produced by Filipino Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

Veterinary drugs require a Certificate of Product Registration before supply in the Philippines. Similarly to the human drug registration process, the applicant requires the relevant Licence to Operate as a Drug Establishment (Manufacturer, Trader, Distributor as appropriate).

The requirements for the initial registration of veterinary drugs are distinct from the human drug registration process, with less consideration of the active ingredients.

A checklist details the documents required for application (https://www.fda.gov.ph/wp-content/uploads/2021/05/Initial-Registration-of-Veterinary-Drugs.pdf).

4.6.1.2 Documents Required from Ingredient Supplier

The technical specifications of all raw materials must be included by the applicant.

Certificates of Analysis of all active raw materials are required from both the API supplier and the drug product manufacturer.

4.6.1.3 Cost and Timeframes

The cost for the application is 3,000 PHP/year (approx. 50 EUR/USD) for branded drugs and 2,000 PHP/year for unbranded drugs, with the applicant choosing a 2-year or 5-year validity. The timeframe for assessment of an initial application is 254 calendar days.

4.6.1.4 Renewal Frequency and Cost

For branded drugs, the cost for a renewal application is 10,000 PHP and for unbranded drugs, the fee is 7,500 PHP. The Certificate of Product Registration issued for a renewal application is valid for five years.

4.7 References

1. Draft for Comments - Rules and Regulations on the Issuance of Authorization for Registration Applications of Drug Products and Drug Substances by the Food and Drug Administration

https://www.fda.gov.ph/draft-for-comments-rules-and-regulations-on-the-issuance-of-authorization-for-registration-applications-of-drug-products-and-drug-substances-by-the-food-and-drug-administration/

2. Draft for Comments - Guidelines for the Importation and Exportation of Finished Drug products and Raw Materials

https://www.fda.gov.ph/draft-for-comments-guidelines-for-the-importation-and-exportation-of-finished-drug-products-and-raw-materials/

3. Administrative Order 2020-0017 Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003

https://www.fda.gov.ph/wp-content/uploads/2022/10/Administrative-Order-No.-2020-0017-Guidelines-on-the-Unified-Licensing-Requirements-and-Procedure-of-FDA.pdf

4. Checklist for New Chemical Entities Registration

https://www.fda.gov.ph/wp-content/uploads/2022/03/New-Chemical-Entities-Monitored-Release-Registration-29Mar2022.pdf

5. Checklist for Initial Registration of Prescription Generic Pharmaceutical Products

https://www.fda.gov.ph/wp-content/uploads/2021/05/Initial-Registration-of-Prescription-Generic-Pharmaceutical-Products.pdf

6. Checklist for Initial Registration of Over the Counter Drugs and Household Remedies

https://www.fda.gov.ph/wp-content/uploads/2021/05/Initial-Registration-of-Over-The-Counter-Drugs-and-Household-Remedies.pdf

7. FDA Memorandum Circular 2013-032 Requirements for the Immediate Release of Products Covered by the FDA at the Bureau of Customs

https://www.fda.gov.ph/wp-content/uploads/2021/08/FDA-Memorandum-Circular-No.2013-032.pdf

8. New Schedule of Fees and Charges of the FDA for Licensing, Registration, and Other Authorizations and Regulatory Services. https://www.fda.gov.ph/wp-content/uploads/2018/06/FINAL-ANNEXES-for-AO-on-INCREASE-OF-FEES.pdf

9. Application Process and Requirements for Post-approval Changes of Pharmaceutical Products

https://www.fda.gov.ph/wp-content/uploads/2021/04/FDA-Circular-No.-2014-008.pdf

10. ASEAN Variation Guideline for Pharmaceutical Products Revision 2

https://asean.org/wp-content/uploads/AVG-Revision-2-endorsed-31PPWG.pdf

11. Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf

12. FDA Circular 2020-033 Procedure for the Use of the Modified Electronic Registration System for Raw Materials and Prepackaged Processed Food Products

https://www.fda.gov.ph/wp-content/uploads/2021/03/FDA-Circular-No.2020-033-1-128.pdf

13. FDA Advisory No. 2022-1003 Release of Veterinary Drugs and Products Covered by FDA at the Bureau of Customs

https://www.fda.gov.ph/wp-content/uploads/2022/05/FDA-Advisory-No.2022-1003.pdf