New Drug Application (NDA) system that accepted only published data in applications for drug licensing
Since 1967, when harm by thalidomide became a critical issue, Japan has had a unique New Drug Application (NDA) system that accepted only published data in applications for drug licensing.
The NDA system constituted the basis of Japan's drug administration, and played an important role in ensuring the safety of medicines in Japan.
However, the system was abolished in 1999.
We requested that the NDA system be re-established, by lobbying, together with other organizations in 1999, but no action has been taken so far.
Topics
- YAKUGAI Ombudsperson
- Tie-up Group
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