FEDERAL COMMISSION FOR THE PROTECTION AGAINST SANITARY RISKS

1. FEDERAL COMMISSION FOR THE PROTECTION AGAINST SANITARY RISKS MEXICO Dr. Federico Meixueiro Director of Evaluation Medicaments February 2003.

2. FEDERAL COMMISSION FOR THE PROTECTION AGAINST SANITARY RISKS Evaluation and authorizations Import Export Registration (Products) Licences (Factories, stores) Drugs Pesticides fertilizers Devices Allopathic Herbal, homeophatic & alternative

3. DRUG REGISTRATION LICENCE OF DRUG FACTORY IN MEXICO. SPECIFIC REQUIREMENTS OF GMP (NOM 059)

4. DRUG REGISTRATION RAW MATERIAL QUALITY • Raw material manufacture’s certificate of analysis • Drug manufacture’s certificate of analysis according pharmacopoeia or validated methods.

5. DRUG REGISTRATION VALIDATION OF RAW MATERIAL MANUFACTURERS Problem: Different manufacturers = different raw material • impurities • degradation products • interchangeability? • Validation of manufacturers: • Of the plant and process: GMP (WHO?, FDA?, CANADA?, NOM 059?) • Of the analytical methods: GLP • Identity and purity of the raw material: certificate of analysis • Sharing validated manufacturers

6. DRUG REGISTRATION • DRUG QUALITY • Description of production process • Analytical controls of the process. • Accelerated stabilities: 3 batch's, 3 months, stress conditions (OMN 073). • Primary packing: material certificate, hermeticity test. • Certificate of analysis of the finished product

7. DRUG REGISTRATION • EFFICACY AND SAFETY • Preclinical information. • Clinical Information (at least fase III) • Labelling (OMN 072), prescribing information • Interchangeability test for “interchangeable generics” • Free sale certificate and GMP certificate if imported drug. • National clinical investigation if no FSC available

8. DRUG REGISTRATION • FUTURE • Stability tests of raw material • New regulation for stability tests of drugs (ICH – harmonized) • Interchangeability test for all generics • Renewal of sanitary registration every 5 ys.

9. POST- DRUG REGISTRATION ASSESSMENT • GMP verification • Pharmacovigilance

10. DRUG REGISTRATION • OTC DRUGS • At present: • Identical procedure • Future: • Official criteria for classification of OTC drugs • Recognition of trilateral criteria?

11. DRUG REGISTRATION MEXICAN CRITERIA FOR OTC DRUGS • Safety shown by phase 4 clinical investigation and pharmacovigilance • Intended to treat self-diagnosis ailments • Automonitoring of therapeutic response • For symptomatic of benign illnesses • No antibiotics • Labelling for rational use

12. DRUG REGISTRATION SPECIAL MEALS FOR MEDICAL PURPOSE At present: Requirements of registration as medicines Future: New regulation (similar to EMEA).

13. HERBAL MEDICINES Products manufactured with vegetal materials… in pharmaceutical form,whose therapeutic efficacy and safety have been scientifically proven.

14. HERBAL REMEDY • Made with medicinal plants or derivatives • Pharmaceutical form • Intended for symptomatic improvement according with traditional or popular knowledge • Substances with known pharmacological effects and/or therapeutic claims are not allowed.

15. DIETARY SUPPLEMENT Products containing plants or their extracts, traditional foods, dehydrated or concentrated fruits, added or not with vitamins or minerals, may be presented in pharmaceutical formand whose purpose is to increase total dietetic ingestion, to complement it or to replace some of its components.

16. SUBSTANCES FORBIDDEN IN HERBAL PRODUCTS Herbal medicines, herbal remedies and dietary supplements are not allowed to contain: • Narcotics or synthetical psychotropic substances. • Allopathic drugs. • Procaine, ephedrine, yohimbine, Larrea divaricata (creosote bush), germanium and any harmful substances. • Animal or human hormones.

17. PURPOSE

18. REQUIREMENTS