Legal basis and adopted statutory policy
- Sections 3(a) and (b) and 26(a) of Republic Act No. 3720 (Food, Drug and Cosmetic Act) provide the legal basis for requiring regulation of herbal medicines.
- E.O. 175 (vesting the Bureau of Food and Drugs with authority to administer and enforce laws pertaining thereto) amends R.A. 3720 through Sections 4 and 19 and supports the BFAD regulatory role.
- The order requires compliance with statutory rules on food, drugs, and cosmetics in the herbal medicines context by adopting the prohibited acts and sanctions in R.A. 3720 as amended by E.O. 175 as applicable.
Purpose and regulatory mandate
- The DOH, through the Bureau of Food and Drugs (BFAD), ensures the safety, efficacy and good quality of Herbal Medicines.
- The order implements registration requirements so herbal medicines placed in commerce meet defined quality, safety, and labeling standards.
- The order establishes controls to prevent circulation of unregistered herbal medicines and to manage product identification through brand name clearance.
Definitions and coverage of “herbal medicine”
- “Plant Material” means fresh or dried aerial or underground parts of a plant (including leaves, flowers, fruits, seeds, stems, wood, bark, roots, rhizomes, and other plant parts), whether whole, fragmented, or powdered, including juices, gums, fatty oils, essential oils, and any other substance derived from the plant for use as is or for further processing (for galenicals or pharmaceutical dosage forms).
- “Herbal Medicines” are finished, labeled medicinal products containing as active ingredient(s) aerial or underground plant parts or any other plant material, or combinations thereof, in crude state or as plant preparations, and may contain excipients.
- Herbal medicines must have specific therapeutic claim(s) and must be intended for diagnosis, alleviation, cure, or treatment of disease, promotion of health, or intended to affect or modify structure or any function of the body of humans or animals.
- Drug preparations that combine plant material with chemically defined therapeutically active substances, including chemically defined isolated constituents used in conventional/western medicines, are not treated as herbal medicines under the herbal medicine registration framework.
- “Common Name” means the generally accepted local name of the plant as recognized in ethno-botanical or other relevant literature.
- “Scientific Name” means the binomial nomenclature (genus and species) and the author name, based on systematic classification, with the genus capitalized and both terms underlined or italicized.
- “Official Name” refers to the scientific name, common/local name, and the part of the active plant material used in the herbal medicine preparation (e.g., “vitex negundo L. Lagundi Leaf”), including the Official Title as stated in the Philippine Pharmacopoeia.
Scope and exempted categories
- Registration and compliance rules apply to all herbal medicines except where the order provides specific exclusions.
- Medicines that do not fall within the definition of herbal medicines are governed by other regulations promulgated for drugs in general.
- Herbal preparations that are fresh plant material or have not undergone any process or treatment other than essential to proper drying, packaging, and storage fall outside the herbal medicine registration coverage.
Core prohibitions and registration eligibility
- Only a licensed establishment for herbal medicines may apply for registration of a herbal medicine product.
- Licensed herbal medicine establishments allowed to apply include the manufacturer, trader, importer, or distributor of the product.
- No person shall manufacture, import, export, distribute, sell, offer for sale, advertise, or transfer any herbal medicines that are not registered with BFAD.
Registration requirements and product evidence
- Registration requires a notarized letter of application and a duly accomplished Form No. 8.
- A Certificate of Brand Name Clearance is required when applicable.
- Every proposed brand name for an herbal medicine must be submitted for name clearance prior to registration filing to prevent similarity with previously registered products across Food, Drugs and Devices, Cosmetics, or Household Hazardous Substances.
- No imported herbal medicine—whether patented and/or registered in other countries—shall receive a brand name clearance certificate if the proposed brand name is identical or similar to any brand name registered with BFAD.
- Brand name application, evaluation, processing, and approval follow Bureau Circular No. 21 series of 1999 (Guidelines for evaluation of brand names for products registered with BFAD) and Bureau Circular No. 8 series of 2003 (Clarification on use of BFAD registered brand names).
- Registration requires a duly notarized certificate of agreement executed between the manufacturer, trader, importer, and/or distributor.
- Registration requires a list of all active plant material(s) and inactive ingredients with specified content:
- A complete list of ingredients (active and inactive) with the corresponding amount per unit dose expressed in the metric system.
- A statement of active ingredient(s) using scientific name with the common/local name printed below the scientific name, with the specific plant part(s) stated after the common name.
- Inclusion of ingredients used in manufacture that may not be present in the finished product (e.g., alcohol), and if alcohol is present in the formulation, it must be expressed in percentage (%).
- Registration requires authenticity certification of plant raw materials:
- A certification as to authenticity of the plant specimen must be obtained from the Philippine National Museum or any BFAD-recognized taxonomist.
- For imported products, authenticity must be obtained from the authorized government agency in the country of origin, with the Philippine Consulate authenticating the document.
- Registration requires physical description and quality/testing data for the finished product:
- Organoleptic and macroscopic description (appearance, texture, color, odor, taste).
- Moisture content.
- pH (if applicable).
- Alcohol content (if applicable).
- Annex A provides standards and limits for specific tests.
- Registration requires a certificate of analysis of submitted samples, showing identity, quality, and safety of each batch sample.
- Registration requires a complete report describing manufacturing methods, facilities, and quality control procedures in manufacture, processing, and packaging, including all in-process quality control procedures and facilities/equipment used.
- Registration requires complete quality control procedures for the finished product, including:
- Manufacturer-conducted quality control tests and establishment of specifications/limits where BFAD has not set standards.
- Detailed test procedures, including sample preparation methods, ensuring quality and batch-to-batch uniformity.
- Data demonstrating absence of synthetic substances and microbial contaminants.
- A defined identification method and, where possible, quantification of plant material; if identification of an active principle is not possible, identification must rely on a characteristic substance/mixture such as a “chromatographic fingerprint” to ensure consistent quality.
- Compliance with general requirements for the particular dosage form.
- Registration requires stability studies to support claimed shelf-life under recommended conditions:
- Room temperature: 30°C ± 20°C and 75% RH ± 5% RH.
- Elevated temperature: 40°C ± 20°C and 75% RH ± 5% RH.
- Cool temperature: 8–15°C.
- Registration requires labeling and labeling materials that comply with detailed formatting and mandatory information rules:
- Label information must be written in English or both English and Filipino, clearly and prominently printed, and sufficiently legible to show color contrast, position, and spacing.
- Mandatory labeling includes: official name and brand name (if any); dosage form and dosage strength; therapeutic claim/pharmacologic category; complete name and address of manufacturer, trader and/or distributor/importer; net content; Rx symbol for prescription product; formulation; indications; contraindications, precautions, warnings where applicable; mode of administration/direction for use; batch and/or lot number; date of manufacture and expiry/expiration date; registration number; and storage conditions.
- For (Rx products), the label must reflect that the Food, Drugs and Devices and Cosmetics Act prohibits dispensing without prescription.
- The principal display panel must contain required items 11.1.4.1 to 11.1.4.6 and conform to presentation in the sample label in Annex B.
- Information outside the principal display panel must contain required items 11.1.4.7 to 11.1.4.15 and may include relevant graphics/illustrations identifying plant material so long as they do not obscure or cover pertinent information.
- Other information may appear on inserts/leaflets or secondary packaging.
- Formulation must state active ingredient(s) with scientific name, common/local name, part used, and corresponding amount/potency in the metric system; alcohol content must be shown in percentage (%).
- The official name must appear inside an outlined box as illustrated in Annex B.
- Registration requires sufficient samples in market/commercial presentation with batch/lot numbers matching submitted certificate of analysis for BFAD laboratory analysis.
- Registration requires evidence of safety and efficacy established before the herbal medicine is made public:
- Acute Lethal Dose 50 (LD50), no-adverse effect level/dose, and toxidrome.
- Pharmacologic effects in animals in vivo and in vitro.
- Bioassay where applicable.
- Non-mutagenicity including Ames test and micronucleus test.
- Sub-chronic toxicity for products intended for more than ten (10) days over ninety (90) days.
- Chronic toxicity for products intended for more than thirty (30) days), with mice for at least nine (9) months, and rats for twelve (12) months or equivalent to lifespan.
- For initial registration, at least fifty percent (50%) of the required chronic toxicity test duration must be submitted.
- For galenical products: Phase I clinical trial.
- For pharmaceutical dosage form products: Phases I, II, III clinical trials.
- No herbal medicine shall be registered if:
- There is a valid report of adverse drug reaction on use of the plant material determined by BFAD.
- There is a valid report of abuse or dependence potential on use of plant material.
- The product contains chemically defined therapeutically active substance(s), including chemically defined isolated constituent(s) of plants used in conventional/western medicine.
- For herbal medicines validated by NIRPROMP of PCHRD-DOST: a Memorandum of Agreement (MOA) must be submitted between NIRPROMP and the applicant.
- Herbal medicines validated by other competent research centers (local or international) must undergo accreditation/approval by the appropriate BFAD committee.
- Imported herbal medicine registration requires:
- A Certificate of Pharmaceutical Product (CPP) issued by the government health agency or appropriate agency in the country of origin and authenticated by the Philippine Consulate.
- No registration unless the product is freely sold in the country of origin; if not freely sold in the country of manufacture, two separate CPPs must be submitted: one from the country of manufacture and one from a country where the product is freely sold.
- Renewal registration of herbal medicines follows Annex D requirements.
Registration process, evaluation, and fees
- A duly licensed herbal medicine establishment files a formal application for registration; the establishment may be the manufacturer, trader, or importer-distributor.
- The applicant must submit data and representative samples supporting registration and must fully disclose all information regarding the product.
- BFAD evaluates submitted documents and samples through:
- Product Services Division evaluation of documents.
- Verification of quality conformance of sample products with BFAD-set standards at the Laboratory Services Division or any laboratory accredited by BFAD.
- BFAD issues the final action on the application for registration, either approval or denial, based on evaluation results.
- Registration fees are non-refundable and are charged for each application:
- Initial registration (for one (1) year):
- Generic: Php 2,000.00
- Branded: Php 3,000.00
- Renewal registration (for five (5) years):
- Generic: Php 7,500.00
- Branded: Php 10,000.00
- Initial registration (for one (1) year):
- Initial registration may be valid for 2, 3, 4, or 5 years upon payment of corresponding fees.
- Renewal registration is for five-year duration starting on the date of expiration of the CPR.
- Cost of laboratory analysis is computed based on the test requirements of the specific product.
Prohibited acts, sanctions, and compliance consequences
- The prohibited acts and sanctions set out in R.A. 3720 as amended by E.O. 175 are adopted for herbal medicines to the extent applicable.
- Compliance enforcement is therefore governed by the statutory prohibited acts and sanctions framework already embedded in R.A. 3720 and E.O. 175.
Repeals, separability, and effect on inconsistent rules
- All orders, circulars, rules, and regulations, or portions thereof, inconsistent with DOH Administrative Order No. 172, s. 2004 are repealed or modified accordingly.
Annex A: Identity, purity, quality standards
- Herbal medicines must have plant identity supported by herbarium specimen preparation from each source and submitted for authentication to the National Museum or any BFAD-recognized taxonomist.
- All herbal medicines must be free from extraneous matters such as soil, excreta, helminths or parasitic ova, stones, other plants, and/or other plant parts of the same plant not intended for use.
- Tests and standards must comply with the pharmacopoeial requirements; plant materials not in any official pharmacopoeia must follow the Annex A test menu.
- Limits for heavy metals in dried plants for adults are:
- Lead: 10 mg/g (ppm)
- Cadmium: 0.3 mg/g (ppm)
- Mercury: 0.5 mg/g (ppm)
- Arsenic: 0.3 mg/g (ppm)
- Limits for herbal medicines for children are recommended by NIRPROMP based on conditions of growth and development and the pathological conditions for which the herbal medicine is indicated.
- Pesticide residue must conform to limits defined in FAO/WHO Codex Alimentarius.
- Aflatoxin limits must conform to total aflatoxin of 20 mg/kg and aflatoxin B1 of 10 mg/kg by ELISA Method or Liquid Chromatography.
- Microbial limits apply by category of plant material intended handling:
- Untreated plant material under acceptable hygienic conditions for further processing:
- Escherichia coli: Negative
- Moulds propagules: Maximum 10⁵
- Staphylococcus: Negative
- Materials pre-treated (e.g., boiling water for herbal teas/infusions) or for topical dosage forms:
- Aerobic bacteria: Maximum 10⁷ cfu/g
- Yeasts and moulds: Maximum 10⁴ cfu/g
- Escherichia coli: Negative
- Salmonellae: Negative
- Staphylococcus: Negative
- Plant materials for internal use:
- Aerobic bacteria: Maximum 10⁵
- Yeasts and moulds: Maximum 10³
- Escherichia coli: Negative
- Salmonellae: Negative
- Staphylococcus: Negative
- Other Enterobacteria: Maximum 10³
- Untreated plant material under acceptable hygienic conditions for further processing:
- Finished product microbial limits are specified by dosage form:
- Solid products:
- Aerobic bacteria: Maximum 10⁴ cfu/g
- Yeast and moulds: Maximum 10³ cfu/g
- Escherichia coli: Negative
- Salmonellae: Negative
- Staphylococcus: Negative
- Other Enterobacteria: Maximum 10²
- Liquid products:
- Aerobic bacteria: Maximum 10²
- Yeast and moulds: Maximum 10²
- Escherichia coli: Negative
- Salmonellae: Negative
- Staphylococcus: Negative
- Other Enterobacteria: Maximum 10²
- Solid products:
- Annex A requires identification tests, including chemical tests; Thin Layer Chromatography (TLC) profile; and other chromatographic procedures such as HPLC, GC-Mass Spectroscopy, and NMR.
- Annex A requires bioassay methods to demonstrate claimed pharmacological activity.
- Annex A requires tests for synthetic substances as appropriate for claimed indication, enumerating examples including Aspirin, Paracetamol, Dipyrone, Phenylbutazone, Pyrazolone, Corticosteroids, Anabolic steroids, Gonadal Hormones, Ephedrine, Sildenafil, indomethacin, chlorpheniramine, aminopyrine, caffeine, and any other synthetic substance.
- Annex A specifies dosage-form-specific tests:
- Tablet: weight variation; content uniformity; disintegration test; hardness test; friability; microbial test.
- Capsule: weight variation; content uniformity; microbial test.
- Syrup/Liquid: viscosity; pH; microbial test.
- Suspension: suspendability; homogeneity; viscosity; minimum fill; pH; microbial test.
- Ointment/cream/semi-solid: palpability; homogeneity; pH; melting point; allergenicity and primary irritation test; microbial test.
- Suppository/pessary: allergenicity and primary irritation test; microbial test.
- Galenicals, including decoctions, infusions, extracts, tinctures, syrups, lotions, and emulsions must pass all requirements specified in the pharmacopeias official in the country.
Annex C: Packaging requirements
- For liquid and semi-solid products in plastic containers, packaging submissions must include:
- Name of materials, name of manufacturer, chemical structure, and physico-chemical properties.
- Test procedures and limits, including methods on how tests were conducted, limits for each test, and results.
- Studies on plastic to substantiate safe use, including chemical tests, physical tests, and biological tests (cell toxicity, tissue implantation) for parenteral and ophthalmic preparations.
- For products in special packaging materials (including accessories), packaging submissions must include:
- List of different components and maximum allowable content.
- Types of materials used in different parts.
- Nature of polymers.
- Official standards and requirements with compliance.
- Toxicity data.
- Technical properties of materials.
- Detailed construction of non-standardized containers.