The document summarizes the drug approval process and relevant laws in the Philippines. It describes the 5 phases of clinical trials required to approve a drug, from pre-clinical testing to post-marketing surveillance. It also outlines the country's PNDF framework for ensuring drug quality, rational use, and self-reliance. Key laws discussed include the 1988 Generic Drugs Act promoting generic drug use, the 1997 Traditional and Alternative Medicine Act, and the 2002 Dangerous Drugs Act strengthening penalties for drug crimes.

1. Drug Approval Process & Other Relevant Laws April 25, 2009 Pia C. Campo, RPh

2. Drug Approval Process Pre-clinical studies – in-vitro & in-vivo; determine efficacy, toxicity, and pharmacokinetics of the drug 5 Phases of Clinical trials Phase 0 – human microdosing studies Phase I – test w/healthy humans  safety, p’kinetics, p’dynamics, tolerability of the drug Phase II – IIA (assess dosing) & IIB (assess efficacy & toxicity) Phase III – multicenter trials, large group, patient w/disease Phase IV – post-marketing surveillance trial

3. PNDP Framework (P-Q-R-S-T) PEOPLE EMPOWERMENT QUALITY ASSURANCE RATIONAL DRUG USE SELF-RELIANCE IN DRUG MANUFACTURING TAILORED PROCUREMENT

4. From Rational Drug Use (RDU) to HTA Early 90s: EO 49 Align procurement w/PNDF Problems w/RDU: Weak regulatory implementation, marketing, & comm. strategy Aggressive industry marketing Restricted decision-making opportunities for doctors Middle 90’s: Evidence-based Medicine  Health Technology Assessment (HTA) Generics Act of 1988 Generic prescribing Generic substitution Creation of National Drug Committee  PNDF: Essential Drug List

5. Consequences: Clinical practice guidelines Increasing use & importance of dis/incentives for prescribers (public & private sectors) Middle 90’s: Evidence-based Medicine HEALTH TECHONOLOGY ASSESSMENT (HTA) PRACTICE

6. Relevant Laws RA 6675: Generic Drugs Act (1988) RA 8423: Traditional and Alternative Medicine Act (1997) RA 9165: Dangerous Drugs Act of 2002

7. RA 6675: Generic Drugs Act (1988) Generic name for essential drugs and promotional incentives Exclusive use of generic name in the manufacture, marketing, and sales of drugs and medicines Generic prescribing (brand name optional) Generic substitution Drug label: name and country of manufacture, dates of manufacture and expiration Medical, dental, veterinary: public & private sectors Cheap Medicines Act contains a contested provision w/c has been withdrawn: generic name only in prescribing drugs.

8. RA 8423: Traditional & Alternative Medicine Act (TAMA 1997) Improve delivery of quality & delivery of health services Traditional and alternative health care & delivery system Indigenous societies: use of traditional medicine  acknowledgment & financial share

9. RA 8423: Traditional & Alternative Medicine Act (TAMA 1997) Biomedicine Scientifcally accepted Allopathy/Western Medicine/Regular Medicine/Conventional Medicine/Mainstream Medicine/Cosmopolitan Medicine Traditional and alternative health care Other than those embodied in biomedicine Traditional medicine Recognized by the people, not necessarily by the scientific community Based on culture, history, heritage, and consciousness

10. RA 8423: Traditional & Alternative Medicine Act (TAMA 1997) Herbal medicines finished, labeled medicinal products active ingredient/s: aerial or underground part/s of plant or other materials, or in combination (crude state or as plant preparations) may contain excipients but not combined with chemically-defined active substances

11. RA 8423: Traditional & Alternative Medicine Act (TAMA 1997) Natural product foods that grow spontaneously (tended or untended) in nature foods prepared from grains, vegetables, fruits, nuts, meats, fish, eggs, honey, raw milk, and the like without the use or addition of additives, preservatives, artificial colors and flavors, or manufactured chemicals of any sort after harvest or slaughter

12. RA 8423: Traditional & Alternative Medicine Act (TAMA 1997) Alternative health care modalities other forms of non-allopathic, occasionally non-indigenous or imported healing methods e.g. chiropractic, acupressure, acupuncture, nutritional therapy, reflexology massage

13. Nursing Implications Do not give to pregnant women. Do not stop prescribed medicine in adults esp. those with maintenance drugs for HPN, high cholesterol, DM.

14. RA 9165: Dangerous Drugs Act (2002) Repealed RA 6425: DDA of 1972 Provisions were added for drug education (focus on schools), rehabilitation Fines and penalty were increased: life imprisonment to death Provisions include how drugs can be reclassified

15. References: Department of Health – Republic of the Philippines. (2006). Health policies and laws . Retrieved April 1, 2008 from http://www.doh.gov.ph/health_policies_laws/republic_act Department of Pharmacology and Experimental Therapeutics –Boston University. (2007). Glossary of terms and symbols used in pharmacology . Retrieved April 1, 2008 from http://www.physpharm.fmd.uwo.ca/psc/resources/frame.ihtml?www=http://www.bumc.bu.edu/www/busm/pharmacology/Programmed/framedGlossary.html Hartigan-Go, K. (2001) Rational drug use: from HTA to Policy the Philippine perspective . Retrieved April 1, 2008 from http://www.philhealth.gov.ph/qa/htaconference2004/download/HTA%20Day%201/PLENARY%20I/3%20RDU%20-%20Philippine%20Experience_GO.pdf McKenry, L. M. and Salerno, E. (1998). Pharmacology in nursing , (20 th ed.). USA: Mosby.