Drug Registration Process In Japan

Drug Registration Process In Japan

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.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering your drug in Japan. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared on the basis of relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of drug registration.