REGULATORY AND ETHICAL REQUIREMENTS FOR HERBAL MEDICINE

Transcription

1 REGULATORY AND ETHICAL REQUIREMENTS FOR HERBAL MEDICINE Hary Wahyu T. National Agency of Drug and Food Control Republic of Indonesia 13 TH FERCAP International Conference Sanur Beach Hotel, Sanur, Bali

2 Outline : Introduction Evidences Regulatory Framework Risk on Clinical Trial

3 INTRODUCTION (1) Traditional medicine: - Spesific for some countries - It is sometimes accompanied by other traditional practice(s), e.g accupuncture, bekam (using chop), massage or others - Sometimes used as complementary or alternative medicine ASEAN Harmonization on TM - Under AEC and Socio Culture pillars - Harmonization on standards and technical requirements

4 INTRODUCTION (2) has a long history the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness Ref : General guidelines for methodologies on research and evaluation of traditional medicine. Geneva, World Health Organization, 2000 (document WHO/EDM/TRM/2000.)

5 INTRODUCTION (3) Single ingredient or in combination Derive from plants, animal, natural mineral Generation to generation According to Indonesia norms Contain no chemical(s) By regulation Should get approval prior to marketing through pre market evaluation

6 INTRODUCTION (4) SIMILARITIES WITH DRUG Raw materials sould be identified Provide pharmacological effect Supported by evidence(s) Comply with Standards and Technical requirements, such as stability, GMP, GLP, GCP and stability guideline VS

7 INTRODUCTION (5) Herbal Traditional herbal Non traditional herbal Traditional health use Traditional treatment Non traditional history New non traditional claim Traditional Claim Non Traditional Claim

8 INTRODUCTION (6) Clearly identified, e.g : Location of plantation Content of compounds and its quantity Method of preparation (e.g method of extraction)

9 EVIDENCE(S) FOR CLAIM Non Traditional Claim History of Use Scientific data Empirical data Classical text Classical literature Pharmacopoeia Preclinical data Clinical data Phase I Phase II clinical data Phase III clinical data Phase IV clinical data (if needed)

10 Regulatory Framework for Product Placement (1) Listing or Registration Registration

11 Regulatory Framework for Product Placement (2) Adm data Full dossier submission prior to marketing Safety data Efficacy data Quality data Strong post market control Pre market evaluation activities mostly done after the products in the market

12 Regulatory Framework for Clinical Trial (1) Clinical Trial Authorization (CTA) Evaluate clinical trial documents and clinical trial product documents Clinical trial document : Protocol, investigator brochure, Informed Consent, Investigator s GCP certificate Regulator approval to conduct clinical trial and to import trial product (if needed)

13 Regulatory Framework for Clinical Trial (2) Official inspection by regulator to check the complience of related parties to GCP To check documents, facilities, records, and any other resources related to the clinical trial The objectives are to have quality and integrity data and to protect human subjects that participate in the clinical trial Can be unannounced or announced GCP inspection GCP INSPECTION

14 The Need of CTA and GCP Inspection Adequat protocol CT conduct comply to GCP The data(s) meet quality and integrity requirements - Willing to have valid and credible clinical data - Protection to the subject and investigator CT conduct non comply to GCP The data(s) don t meet the quality and integrity requirements it will bring to the false evaluation decision in the registration process

15 Clinical Trial Risk 1. Risk on the subjects Invetigational product exposure Need review Design Drug quality CT conduct Threaten subject s safety 2. Risk from unreliable results Safety and efficacy profil?? Threatened people s safety Need review Bias evaluation result Design CT conduct 3. Non comply to GMP for IP Threatened subject s safety

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