The European Medicines Agency (EMA) published its 2017 work plan for Good Clinical Practice (GCP) inspections.
The plan involves cooperating with the US Food and Drug Administration (FDA) to avoid duplication of inspections. Other aims include the development and documents such as EMA GCP inspection procedures and guidelines to be aligned to the new Clinical Trials Regulation, and training and support for inspectors with a focus on bioequivalence studies.
Also on the agenda for this year are continued work on the preparation of a guidance document on the use of electronic and data capture systems in clinical trials, and clarification of inspectors’ expectations on processes and procedures in connection with data protection.
The plan says that to save resources, duplication of inspections should be avoided and increased inspection coverage will be ensured for MAA submitted to both, the Agency and the US FDA. EMA will also look to assist other countries in the development of GCP inspection roles, including Albania, Macedonia, Montenegro, Serbia, Turkey, Bosnia and Herzegovina and Kosovo.
To read the plan, please click here.