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B ridging Update in KOREA

B ridging Update in KOREA. In-Jin Jang, MD Seoul National University College of Medicine and Hospital. Bridging Concept and Regulatory Changes in Korea. Major regulatory changes. since 1999. Adoption of the Bridging Concept : effective since June 2001

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B ridging Update in KOREA

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  1. Bridging Update in KOREA In-Jin Jang, MD Seoul National University College of Medicine and Hospital

  2. Bridging Concept and Regulatory Changes in Korea

  3. Major regulatory changes since 1999 • Adoption of the Bridging Concept : effective since June 2001 • Separation of IND from NDA : Participation in international study enabled since December 2002

  4. Bridging Concept • “Bridging Data” = “Korean Data” • “Bridging Study” = “A trial conducted in Korean” “Bridging Data” means data on the results of trials conducted in Koreans living home and abroad, which are excerpted or selected from the clinical data package or obtained from the bridging study. “Bridging Study” means a trial conducted in Koreans in Korea for the purpose of obtaining bridging data in case it is difficult to apply the foreign clinical data as it is because there is a difference in an ethnic factor relating to the safety and efficacy of a drug.

  5. New Product Approval New Product Candidate At least ONE Bridging Study in KOREAN (Global or Local) 7 waiver categories Bridging Exemption

  6. Bridging Waiver Category • Orphan drugs • Drugs for life-threatening diseases • Diagnostic reagents • No systemiceffect • Proven ethnic insensitivity • New drugs being developed inside or outside of Korea that are intended to conduct clinical trials in Korea • Other drugs givenwaiver by KFDA

  7. Status of Bridging Waiver (2000- Sep.2003)

  8. Status of Bridging Waiver(2000-Sep.2003)-continued

  9. Bridging Experience

  10. Increased Number of Clinical Trials KFDA database

  11. Increased Number of Multinational Clinical Trials (Dec. 2002 ~ Sep. 2003) KFDA database • Approved drugs for label change; • 29 protocol, 21 drugs • 28 Phase III & 1 Phase II studies • Unapproved new drugs; • Potential bridging data generation • 39 protocols, 20 compounds • 22 Phase III, 6 Phase II & 1 Phase I studies

  12. KFDA database 140 120 100 80 days 60 40 20 1998 1999 2000 2001 2002 2003 year Reduced KFDA Review Time

  13. Recent Bridging Studies (Sep. 2002 ~ Jul. 2003) KFDA database • Nine products (10 protocols) got IND’s for bridging studies • Phase III; 6 protocols • Antibiotic, Antiepileptic, Antirheumatic (Biological), Osteoporosis Rx., Lipid lowering drug, Anticoagulant • Phase I; 4 protocols • Antihistamine, CV biological drug, Lipid lowering drug, Antibiotic • Seven protocols from domestic sponsors for product licensing-in from Japan and Italy (1)

  14. Approved products by PK bridging • * Ten more drugs are under PK bridging study • - Five in review or reporting process • - Five in study or protocol development process

  15. Acceptability of Asian Data • Asian; Same ethnicity ? • Mutual recognition of Asian data ? • Statistics • Statistically meaningful sample size ? • Multinational study; subgroup analysis ? • Many study design issues • Similarity ? What metric? • Titration drug • Placebo • Need more scientific and flexible design & review • Bayesian, Mixed effect modeling, Simulation, Pharmacogenomics, etc. Bridging Issues in Korea

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