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When do we need to comply with the new European CTR?

Answer:

According to the European Commission’s website on Medicinal products for human use http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm and the respective document, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_53..., the directive has been effective since April 2014. Air Force 1 High KPU