Scope and Coverage
- Applies to all herbal medicines regulated by the Department of Health (DOH) through the Bureau of Food and Drugs (BFAD).
- Excludes preparations that are fresh plant materials without processing beyond drying, packaging, and storage.
- Non-herbal products fall under other applicable drug regulations.
Definitions
- "Plant Material": Any fresh or dried part of a plant including juices and oils used for further processing or as is.
- "Herbal Medicines": Finished medicinal products containing active plant materials with therapeutic claims for diagnosis or treatment in humans or animals.
- Excludes drug preparations combining plant materials with chemically defined conventional drug substances.
- Definition of common, scientific, and official names provided for clarity in labeling and documentation.
Policies and Guidelines
- Only licensed establishments (manufacturers, traders, importers, distributors) can apply for herbal medicine registration.
- Herbal medicines must be registered with BFAD before manufacture, importation, sale, distribution, advertisement, or transfer.
Registration Requirements
- Submission of notarized application and Form No. 8.
- Brand name clearance to prevent duplicate or confusing names, including rules for imported products.
- Certificate of agreement among involved establishments.
- Complete list of active and inactive ingredients with scientific and common names.
- Certification of plant specimen authenticity by recognized taxonomists or Philippine National Museum.
- Detailed physical description and quality standards of the finished product per Annex A.
- Certificate of analysis and comprehensive manufacturing and quality control reports.
- Stability studies under specified temperature and humidity conditions to support shelf-life claims.
- Detailed labeling requirements including therapeutic claims, dosage, precautions, batch and registration numbers, and storage.
- Samples of commercial presentation must be submitted for laboratory analysis.
- Evidence of safety and efficacy data including toxicity studies, pharmacologic and clinical trials as applicable.
- Special provisions for imported herbal medicines including authenticated Certificate of Pharmaceutical Product.
- Renewal requirements outlined.
Registration Procedure
- Licensed establishments file formal application with complete documentation and samples.
- BFAD evaluates documents and conducts laboratory tests.
- Final approval or denial based on evaluation results.
- Payment of non-refundable registration and laboratory fees (initial and renewal, generic and branded rates specified).
Prohibited Acts and Sanctions
- Prohibited acts and penalties under R.A. 3720 and E.O. 175 apply as appropriate.
Repealing Clause
- Inconsistent orders, circulars, rules, or regulations are repealed or modified accordingly.
Effectivity
- The regulations take effect fifteen days after publication in two newspapers of general circulation.
Annex A: Standards for Identity, Purity, and Quality
- Authentication of plant materials through herbarium specimens.
- Herbal medicines must be free from extraneous matter and meet pharmacopoeial standards or equivalent.
- Required tests include organoleptic description, ash content, extractives, moisture content, heavy metals, pesticide residues, microbial limits, aflatoxin levels, chemical identification (TLC, HPLC, etc.), and bioassays.
- Finished product quality tests include moisture, pH, microbial limits, and testing for synthetic substances.
- Specific tests for various dosage forms such as tablets, capsules, liquids, ointments, and suppositories.
- Galenical products must comply with national pharmacopeias.
Annex C: Packaging Requirements
- Detailed information on materials used for plastic containers and special packaging.
- Toxicity and technical tests must substantiate safety claims, especially for parenteral and ophthalmic preparations.
- Compliance with official standards and thorough documentation required.