PMDA Issues New Safety Guidance for Bioequivalence Studies in Japan
What happened
The Pharmaceuticals and Medical Devices Agency published new safety guidance for bioequivalence studies in Japan. This advice addresses the safety of healthy adult participants in these studies, particularly for products related to psychiatric and neurological symptoms. The guidance fills a gap because existing rules did not cover the development of generic drugs, providing a general approach based on prior consultations. It covers general advice on safety management systems and handling specific safety risks.
From raps.org
Why it matters
The guidance is a response to increased product development and addresses safety concerns raised by sponsors. Since Eli Lilly and Company's drug products require formal regulatory approval from the Pharmaceuticals and Medical Devices Agency, these changes affect the path to commercialization in Japan.
From raps.org
Who's involved
- Pharmaceuticals and Medical Devices AgencyRegulatory agency responsible for publishing safety guidance in Japan.
- Eli Lilly and CompanyCompany whose drug products require formal regulatory approval from the Pharmaceuticals and Medical Devices Agency.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Eli Lilly and CompanySpeculative
Eli Lilly and Company could face increased compliance costs and development time for drug products in Japan.
Keep exploring
The entities involved
-
Japanese
language spoken in East Asia
-
Pharmaceuticals and Medical Devices Agency
administrative agency in Japan