Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 

illustrative image

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, in Excel format (not PDF), to the following address:

 iche6_r3@ema.europa.eu                    

© European Medicines Agency, 2023.

 

Clinical Research News

Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 
ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
The study of the new investigational drug for acute myeloid leukemia and myelodysplastic syndrome
Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers
Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults
A new study of Dexpramipexole in adolescents and adults with severe Eosinophilic Asthma

即将进行的临床试验

Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 

All jobs

赞助者和合作者

医疗条件

药物干预

3
订阅