Bridging Update in KOREA.ppt

Bridging Concept and Regulatory Changes in Korea Major regulatory changes Adoption of the Bridging Concept : effective since June 2001 Separation of IND from NDA : Participation in international study enabled since December 2002 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. Bridging Waiver Category Status of Bridging Waiver (2000- Sep.2003) Status of Bridging Waiver(2000-Sep.2003)-continued Bridging Experience Increased Number of Clinical Trials Increased Number of Multinational Clinical Trials (Dec. 2002 ~ Sep. 2003) Recent Bridging Studies (Sep. 2002 ~ Jul. 2003) Approved products by PK bridging Bridging Issues in Korea * * Bridging Update in KOREA In-Jin Jang, MD Seoul National University College of Medicine and Hospital since 1999 New Product Approval New Product Candidate 7 waiver categories At least ONE Bridging Study in KOREAN (Global or Local) Bridging Exemption Orphan drugs Drugs for life-threatening diseases Diagnostic reagents No systemic effect Proven ethnic insensitivity New drugs being developed inside or outside of Korea that are intended to conduct clinical trials in Korea Other drugs given waiver by KFDA Product Name (Company) Waiver Category Cancidas (MSD) Vfend (Pfizer) TS1 (Che-il, Taiho) Iresa (AstraGeneca) Crixivan (MSD) AIDS, Cancer, or Life-threatening disease Asperogilosis / Cancer / HIV Zyvox (Pharmacia) Tamiflu (Roche) Arixtra (Sanofi-Synthelabo) Invanz (MSD) No ethnic difference A