FDA the FDA Gatmaitan – Medrano

Food and Drug Administration Formerly the Bureau of Food and Drugs (BFAD) Has several functions and powers acting as a regulatory board for all food and drugs marketed. It was reorganized under the Republic Act 9711.

The Functions of the FDA…  Can be classified into 4 major groups:  The collection and quality, efficacy and SAFETY testing of health products samples.  Collection of data on adverse events and possibly harmful products (largely reactionary)  The recommendation of standards in the storage, distribution and manufacture of drugs.  The conduction of research on food and drug products.

So… Testing Data Analysis StandardsResearch FDA

Specific provisions o To administer the effective implementation of R.A and of the rules and regulations issued pursuant to the same ; o To assume primary jurisdiction in the collection of samples of health products ; o To analyze and inspect health products in connection with the implementation of R.A. 9711; o To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;

Specific provisions o To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality ; o To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person;

Specific provisions o To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not registered with the FDA Provided, o After due process, to order the ban, recall, and/or withdrawal of any health product found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization;

Specific provisions o To strengthen the post market surveillance system in monitoring health products as defined in R.A and incidents of adverse events involving such products; o To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products; o To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA;

Specific provisions o To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in R.A. 9711; o To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director- general for confiscated goods in strategic areas of the country especially at major ports of entry; and o To exercise such other powers and perform such other functions that may be necessary to carry out its duties and responsibilities under R.A.9711.

A food/dietary supplement… Is a processed food product intended to supplement the diet vitaminmineral Amino acid Herb/ other botanicals Food supplement

A food/dietary supplement… conforms to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements.

Herbal medicines are… finished, labeled, medicinal products that contain as active ingredient/s aerial or underground part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations.

Herbal medicines are… JuicesGums Oils Isolated plant constituents Plant matter

Herbal medicines are…  recognized in the Philippine National Formulary ;  intended for use in the treatment or cure, mitigation, of disease symptoms, injury or bodily defect for use in man ;  other than food, intended to affect the structure of any function of the body of man;  put into finishes, ready to use form by means of formulation, dosage or dosage directions;

How are locally manufactured drugs approved? ApplicationSafety tests Quality Control Paying of Registration Fees

Step 1: Application (A.O. 42) The application contains all the following:  Full list and amount of all ingredients used  Technical specification of all the ingredients used as component.  Description of the finished drug product.  Labels, labelling materials, package insert, brochures and other advertising materials  Sufficient sample for laboratory analysis.

Step 2: Safety Tests  Oral LD 50 in Rats  Pharmacologic studies  in vitro-depending on tissue uses; on dogs, cats and turtles  in vivo-on-dogs and cats.  Mutagenicity studies  in vitro  in vivo  Date on safety and efficacy  Dosage formulation

Step 3: Quality Control  Test for the presence of synthetic drugs  Test for the presence of heavy metals  Test for alcohol content (<10%)  Analysis for Impurities  Characteristics of the drug in tablet form, suspension form, ointment and suppository preparations.

Step 4: Payment  Drug preparation containing only one active ingredient shall be charged a fee of fifty pesos (P50.00)  Those containing more than one active ingredients shall be charged a fee of one hundred pesos (P100.00)

Administrative Acts of the FDA  EO 51 – Milk Code  IRR of EO 51 - Revised Implementing Rules & Regulations of Milk Code  EO 302 – Philippine Pharmacopoeia  RA Expanded Senior Citizens Act of 2003  RA 9211 – Tobacco regulation Act of 2003  IRR of RA 9211 – Inter-Agency Committee - Tobacco

Rationale of Renaming BFAD RA No  The Bureau of Food and Drugs (BFAD) was renamed as the Food and Drug Administration (FDA) to strengthen and rationalize its regulatory capacity thru  The establishment of adequate testing laboratories and field offices,  Upgrading its equipment  Augmenting its human resource complement  And by giving authority to retain its income