Risk Communication inNDA (New Drug Application).ppt

Risk Communication inNDA (New Drug Application) Massie Ikeda MD, PhD Chief Medical Reviewer Pharmaceuticals and Medical Devices Agency Standard Disclaimer This is not an official PMDA/MHLW guidance or policy statement. No official support of endorsement by PMDA/MHLW is intended or should be inferred. Today’s TopicsWhy do we need: Clinical trials ? Regulatory body ? Risk communication ? “New Drug” reminds you of??? Newspaper Articles Tough Diseases: HIV, Cancer High-Techs in Medicine Severe Adverse Effects Mega Pharma Companies Clinical Trials Why do we need clinical trials ? Is it OK with animal data only ? Let safe drugs only go into the market？ Are clinical trials dangerous？ Let us leave to the doctors？ Why do we need placebo ? We humans needour own human data.You never want dog or cat food on your dinner menu.The same with your drug. Are you happy withalternative medicine only?You probably need drugs whose data have been scientifically reviewed. Human Experiment Era Today’s TopicsWhy do we need: Clinical trials ? Regulatory body ? Risk communication ? Benchmarking of Drugs: Who does it ? Independent BodyRegulatory Authority PMDA FDA EMEA ICHInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Japan, USA, EU To make common regulations and share data on clinical trials It is not an academic conference Working on drugs but not on devices What is ICH E5 for? For providing good drugs faster to everybody in the world, especially ICH resions. It is not intended to bypass important domestic clinical studies. Importance of ethnic differences Intrinsic PK/PD, genetic analysis (in future), etc. Extrinsic differences in clinical practice, etc. Ethnic Difference in Alcohol Dehydrogenase Importance of ethnic differences Intrinsic PK/PD, genetic analysis (in future),