The Philippines is the third-largest pharmaceutical market in ASEAN after Thailand and Indonesia. In 2019, total generic drug sales were PHP82.3 billion accounting for 63% of prescription sales and estimated to reach PHP110 Billion by 2024.
The highest cost of medicines in the Philippines among ASEAN countries driving the purchase of more generic medicines than branded medicines. Foreign pharmaceutical companies account for over 75% of the Philippines’ pharmaceutical market.
Key factors for the pharmaceuticals market growth
- Fast-growing population and progressive government investment healthcare.
- Increasing pharmaceutical imports and expected to reach $1.4 bn in the future.
- Increasing sales of generic drugs. Around 60% of pharmaceutical sales are of generic drugs while 40% of branded drugs.
- Supportive government initiatives increasing access and demand for affordable and quality medicines e.g Universal Health Care Policy, BnB project (Botika ng Barangays), Cheaper Medicine Act 2007, etc.
- Growing per capita expenditure on pharmaceuticals.
Prevalence of the diseases
- High prevalence of both communicable and non-communicable diseases.
- Increasing incidence of HIV cases each day.
- Tuberculosis is one of the top ten leading causes of death.
- An increasing number of cases of malaria and dengue fever (around 100,000 cases of Dengue fever per year).
- Non-communicable diseases accounting for around 70% of all deaths e.g cardiovascular disease, lung cancer, breast and cervical cancer, diabetes.
Regulatory for Generic drugs in the Philippines
The Food and Drug Administration (FDA) under the Department of Health regulates the pharmaceuticals in the Philippines and ensures the safety, quality, efficacy, purity of products through effective implementation of the national regulatory framework harmonizing with the international guidelines.
To register your generic drug in the Philippines you need to know the following
- What are various application categories for generic drug registration?
- How can foreign manufacturers register their generic drugs in the Philippines?
- How about BA/BE studies?
- Is the foreign bioequivalence data acceptable in the Philippines?
- What are the requirements to register your generic drug in the Philippines?
- How about the manufacturing site accreditation, or other such requirements?
- What are the timelines and costs involved in generic drug registration?
- What is the post-approval process such as importation and license to import?
Get Details on Regulatory, Requirements, and Process for Registering Generic Drugs in the Philippines.
Credevo has prepared a report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.
What would you get by downloading this report?
- Details on the regulations, requirements, and process to register the generic drugs in the Philippines.
- Free assessment by Credevo to review your generic products and available data to know the applicable regulations.
Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in the Philippines. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the Philippines regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.
Generic drugs in Philippines
Generic products are considered to be bioequivalent or essentially similar to reference drugs. These are drugs that are not covered by patent protection and are pharmaceutically equivalent but may or may not be therapeutically equivalent, and labeled solely by their international non-proprietary name or generic name.
Generic drugs in the Philippines are classified depending on the dispensing category as follows
- Prescription and
- Non-prescription products
So, the requirements differ based on the drug category. One needs to identify to which category does the drug belongs before initiating any process of registration.
License to Operate (LTO)
Before applying for product registration in the Philippines, a local company may require a License to Operate (LTO) issued by the Food and Drug Administration (FDA) prior to engaging in any activity of manufacture, importation, exportation, distribution, market, promotion, or advertisement of health products.
For more details on the applicability of LTO for generic drug registration, application details, and validity of LTO, click here.
Generic drug application requirements
Department of the Health Republic of Philippines adopted ACTD and Common Technical Requirements (ACTR) for pharmaceutical product registrations in 2013.
The requirements for generic drug registration is based on the dispensing category of the products.
Click here for more details on application requirements for each category of generic drugs and detailed format requirements.
Foreign GMP clearance
For registering your generic drug in the Philippines, you need to know whether the manufacturers need to prove GMP clearance. In the Philippines, the standard of GMP is the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
For more details on foreign manufacturers, GMP requirements, and manufacturing site inspections, click here.
The review period basically depends on the requirement for inspection, fulfillment of required documents, category of generic drugs and many other such factors.
Download the report for detailed information on registering the generic drug in the Philippines with the fee, cost and timelines for registration.
BE studies conducted overseas
All BE studies conducted overseas need to follow the ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies. For registering the generic drug in the Philippines, you need to know whether you need to submit the BA/BE studies.
- The process starts with the submission of an electronic copy application by the applicant using. A hard copy of the integrated application form is required.
- Once an applicant submits the application dossier, the FDA through the Center for Drug Regulation and Research (CDRR) evaluates the documents and determines if the product meets the requirements of safety, efficacy, and quality. If the product meets these standards, a Certificate of Product Registration (CPR) is issued.
- Depending on the conditions of deficiencies, a Notice of Deficiency (NOD) or Letter of Disapproval (LOD) may be issued.
For detailed process can be found in the “The Report on Generic drug registration in the Philippines“
CPR is valid for 5 years, an applicant can apply for renewal 120 days before the expiration of CPR.
The processing fee depends on the type of product and whether the drug product is manufactured locally or manufactured overseas and imported.