CTR

Question 1

Tell me about the CTR

Answer 1

Clinical Trial Regulation 536/2014
* This replaced the Clinical Trial Directive – 2001/20/EC
* Common system of authorisations for CTs
* Guidelines (e.g. format of authorisations)
* Inspections of IMP Manufacture
* Inspection of GCP, GLP Clinical data and records
* Batch Release by a QP as per 2001/83/EC (was 75/319/EC)… Transitional arrangements for
* those performing the role
* Adverse reaction reporting
* Testing of comparator medicines/importation testing… to be in accordance with
* authorisations
* Includes low interventional trials
* CTA applications to go through a central EU portal
* Some relaxations for radiopharmaceuticals used in trials and for hospitals preparing IMPs