Regulatory information - Replacement of GCP non-compliant pivotal studies in centralised marketing-authorisation applications not accepted
Move aims to reinforce compliance with good clinical practice
The European Medicines Agency (EMA) will not accept the replacement of a pivotal clinical study that has been found to be non-compliant with good clinical practice (GCP) by another study during the assessment of a centralised marketing-authorisation application. This position, outlined in a paper published today, aims to reinforce the application of GCP during the conduct of clinical trials by applicants.
GCP is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects.
According to European Union (EU) legislation, all clinical trials submitted to a regulatory authority in the EU to support a marketing-authorisation application must be conducted in compliance with GCP.
This ensures that the rights, safety and well-being of the individuals recruited for these trials are protected and that clinical trial data are credible and reliable irrespective of where in the world the trials have been carried out.
EU national regulatory authorities carry out inspections to verify compliance with the GCP standards.EMA may request national competent authorities to verify compliance with the principles of GCP for centrally authorised medicines.
If a study is found to be GCP non-compliant during an inspection carried out during the assessment of a marketing-authorisation application, the applicant may comment on the inspection findings, provide a re-analysis of the data and/or present a justification why, in their view, the data can be relied upon. These considerations will be taken into account by EMA's Committee for Medicinal Products for Human Use (CHMP) during its assessment of the benefits and risks of the medicine.
However, EMA will not allow the replacement of a pivotal study which cannot be relied upon due to GCP non-compliance by another study during the assessment of the application. Applicants can still submit a new application for marketing authorisation for the same medicine supported by appropriate GCP-compliant data from a pivotal study.
EMA reminds all applicants that it is their responsibility to submit data that are compliant with the legal requirements, including GCP.