Understanding the regulations for drug registration in Japan is critical as the process requires strategies and a systematic approach to minimize the timelines and make an efficient registration process.
Here are some of the critical points that need to be clear before registering the drug in Japan
- Which is the preferred language for submission?
- How about accepting overseas clinical trial data by the PMDA?
- What would be the process for the overseas manufacturer?
- What are the timelines & costs involved in the drug registration?
- Are there any faster review & approval process? and many more
Get Details on Regulatory, Requirements, and Process for Registering Pharmaceuticals in Japan.
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