Philippines Generic Drug Registration Process
The Philippines is the third-largest pharmaceutical market in ASEAN after Thailand and Indonesia. In 2019, total generic drug sales were in the Philippines were PHP82.3 billion, and accounts for 63% of prescription sales and estimate to reach PHP110 Billion by 2024.
The highest cost of medicines in the Philippines among other ASEAN countries is one driving factor for more generic drugs purchase than branded medicines. Foreign pharmaceutical companies account for over 75% of the Philippines’ pharmaceutical market.
Top key factors for the generic drug market growth in the Philippines
- Fast-growing population.
- Progressive government investment in the health care sector, and growing per capita expenditure on pharmaceuticals.
- 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 medicines.
- Supportive government initiative to increase access and demand for affordable and quality medicines. Example Universal Health Care Policy, BnB project (Botika ng Barangays), Cheaper Medicine Act 2007, etc.
Prevalence of the diseases
- Increase in prevalence of both communicable and non-communicable diseases.
- Increase incidence of HIV cases each day.
- Tuberculosis is one of the top ten leading causes of death.
- Increasing malaria and dengue diseases.
- Non-communicable diseases account for around 70% of deaths. Example 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. The FDA ensures the safety, quality, efficacy, purity of products by implementing the national regulatory framework harmonizing with the international guidelines.
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Generic drugs in the Philippines
Generic products are products that are bioequivalent or essentially similar to reference drugs. These drugs 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 class 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) before 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.
Requirements for generic drug application
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 depend 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
To register 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 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.
Bioequivalence (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 five years, and 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.
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