Taiwan FDA has Amended the Regulations for Good Clinical Practice in Consideration of ICH E6(R2)

The changes are with the consideration of the ICH E6(R2), key changes are:
Article 23: sponsor’s subsidies and payments provided to subjects;
Article 30: qualifications and abilities of the investigator
Article 37: responsibilities of the investigator
Article 54: sponsor’s appointment of personnel
Article 55, sponsor’s implementation of an electronic data processing system.
Article 73: about the responsibility of the sponsor for monitoring plans.

For more information, please refer to

Share on Linkedin Send to Email

Questions? Request more information from our specialists!

Contact Us

More News