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Please note that this is not European Medicines Agency official website. Though we are committed to posting updated information on the GCP principles from all over the world, we do not guarantee its correctness or state-of-the-art.

If you seek official comments on GCP or other clinical trials related questions, please forward your requests to the official Medicines Agency website in your country.

Clinical Research News

Applying for a Paediatric investigation plan (PIP): review of the EMA guidelines
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

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