On 26 May 2023, the European Medicines Agency (EMA) published the Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b and the Template to submit comments on ICH E6 (R3) Guideline for Good Clinical Practice.
The draft is released for public consultation on 26 May 2023 and comments will be collected till 26 September 2023.
The template in the excel format can be downloaded here.
According to the EMA, any comments and the identity of the sender will be published unless a specific justified objection is received.
When completed, this form should be sent to the European Medicines Agency electronically, to the following address:
© European Medicines Agency, 2023.