How to Register Drugs and Pharmaceuticals in the Philippines

Under Republic Act No. 9711 (FDA Act of 2009), you can’t manufacture, import, distribute, or sell drugs or pharmaceutical products without meeting safety and efficacy standards mandated by the FDA. Part of these standards is having a License to Operate (LTO) and obtaining a  Certificate of Product Registration (CPR). 

In this guide, we will outline what are the legal requirements, technical dossier structure, and steps on how to register drugs and pharmaceuticals in the Philippines. 

Phase 1: Securing a License to Operate LTO

Before registering a specific drug product, a company must obtain a License to Operate (LTO). Under RA 9711, only establishments with a valid LTO may apply for product registration. It authorities your company to engage in activities involving health products in general. 

1. Identifying Your Business Role

The FDA classifies drug establishments into specific categories based on their function:

• Drug Manufacturer: Entities that produce drugs locally.
• Drug Trader: Entities that own the product and formulation but outsource manufacturing to a third party.
• Drug Distributor (Importer/Exporter/Wholesaler): Entities that import foreign-made drugs for local distribution.

Because foreign companies cannot hold an LTO directly, they often take the “distributor-importer” path that involves setting up their own subsidiary in the Philippines. Alternatively, you can partner with Emerhub and act as your local license holder so you can import without starting a new company. 

2. Appointing a “Qualified Person”

Every licensed drug establishment in the Philippines is required to employ a Philippine Registered Pharmacist as its “Qualified Person.”

This pharmacist is legally responsible for the company’s compliance with Good Manufacturing Practices (GMP) and Good Distribution and Storage Practices (GDSP). They serve as the primary liaison with the FDA and oversee all product registration applications.

3. Physical Office and Warehouse

All licensed establishments must maintain a physical office and a dedicated storage facility (warehouse) that complies with FDA standards. The FDA conducts mandatory physical inspections to verify temperature controls, pest management systems, and security protocols before an LTO is granted.

Phase 2: Obtaining a Certificate of Product Registration (CPR)

A CPR or Marketing Authorization is the FDA’s official approval for your drug products to enter the Philippine market. It confirms that your product has passed the FDA’s evaluation for quality, safety, and efficacy.

After securing an LTO, you must apply for a CPR for each specific drug product. Both over-the-counter (OTC) and prescription drugs require a CPR. There are no exceptions, regardless of whether the product is locally manufactured or imported.

Applications are made via the FDA ePorta (for LTO management)l and eServices systems (product registration, renewals, and post-approval variations). The person-in-charge uploads the dossier, followed by FDA review. 

Requirements for Pharmaceutical Product Registration

One of the reasons many CPR applicants get rejected is due to incomplete or inconsistent information. If rejected, you need to resubmit your documents and wait for your application to be processed all over again. 

As your partner, Emerhub ensures that you have all the needed documents, especially for complex and high-risk pharmaceuticals. 

Four Parts of the ACTD Dossier

Prescription drug submissions must follow the ASEAN Common Technical Dossier (ACTD) format, as mandated under Administrative Order No. 2013-0021. This standardized format is used across all ASEAN member countries and covers administrative, quality, non-clinical, and clinical data sections. It follows four parts: 

• Part I: Administrative Data and Product Information: This section contains the administrative requirements, including:
  • The formal application form.
  • The Certificate of Pharmaceutical Product (CPP) from the country of origin.
  • Product labeling (drafts for inner and outer packaging).
  • The Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).
• Part II: Quality Document (Pharmaceutical Aspects): This section provides technical data regarding the drug’s composition and stability:
  • Detailed manufacturing process descriptions.
  • Manufacturing process validation data.
  • Stability data proving shelf life under Climate Zone IVB conditions (30°C and 75% relative humidity).
  • Specifications and analytical procedures for raw materials and finished products.
• Part III: Non-Clinical Document (Safety): For new chemical entities, this includes reports on animal studies, toxicity, and pharmacology. For generic drugs, applicants may reference existing scientific literature if the product is identical to an innovator drug already approved in the Philippines.
• Part IV: Clinical Document (Efficacy): This section contains clinical trial data proving human efficacy. For generic drug applications, the Bioequivalence (BE) Study is the critical component, demonstrating that the generic version is absorbed at the same rate and extent as the reference innovator drug.

CPR Validity and Renewal

Drug CPRs have varying validity periods depending on product type and registration status. Under FDA Circular No. 2018-012, products under Monitored Release (MR) status are issued a CPR valid for three (3) years. Standard CPRs are generally valid for five (5) years. You must file your renewal at least 3 to 6 months before expiry to avoid gaps in your legal status.

Pathways for Pharmaceutical and Drug Registration

As a foreign company, you have two primary pathways to register your drugs and pharmaceuticals in the Philippines. Keep in mind that foreign entities cannot hold an LTO directly. Each option has distinct implications for ownership, control, and speed to market. 

Option A: Starting a Subsidiary

This involves establishing a local corporation, securing a warehouse, and hiring a dedicated pharmacist. Your local entity owns the LTO and all CPRs directly. This provides maximum long-term control over your portfolio. This route provides full corporate control but requires significant time and capital investment. 

If you take this path, Emerhub can help with incorporating your company. We will handle the entire SEC incorporation process, tax registration, and provide ongoing corporate secretarial and accounting services. We ensure your legal entity is in good standing while you focus on the FDA applications.

Option B: The “Product Holder” Model

This pathway allows you to enter the market without setting up your own company. You partner with a licensed distributor like Emerhub to act as your “License Holder” or “Importer of Record.” Under this model, we provide the necessary LTO, warehouse, and pharmacist to register and hold the products on your behalf. 

This is the fastest way to start the CPR application because you skip the 3-6 month process of setting up a company and obtaining a new LTO. You can minimize the initial overhead and allow for rapid market testing. Our corporate team manages the underlying compliance. 

Explore both your options by talking to our local experts in the Philippines. Fill out the form below!