The European Medicines Agency (EMA) recently released several new guidelines related to the clinical aspects of pharmaceutical development. Compliance of the trial master file (TMF) to Good clinical practices is the object of the draft guideline EMA/15975/2016, issued by the GCP Inspectors Working Group (GCP IWG) on March 31st, 2017.
The document discusses the main requirements posed by the new “Clinical Trials Regulation” (EU) No 536/2014 and ICH-GCP E6 and that impact the preparation and filing of the TMF, both in the paper and electronic format.
Content and management of the trial as well as archiving of all relevant documentation, audit by the sponsor and inspection by the health authorities of Member States are all taken into consideration in the new EMA’s guideline. The document also clarifies retention times, and expectations in case of digitization and consecutive destruction of paper documentation.
It includes also a revised version of the reflection paper on TMF previously published by EMA, whithin which have been also inserted the comments collected during the public consultation phase (01 February – 30 April 2013).
The European Commission has released on March 24th, 2017 the implementing regulation detailing arrangements for the good clinical practice inspection procedures (C(2017) 1812 final).The document refers to clinical trials conducted in the UE – or referring to in MAA in the EU – and provides detailed information about the timeframe for inspections, the quality system that has to be set in place by Member States to ensure their quality, as well as qualifications, training and experience of the workforce employed as inspectors. Powers of inspectors and recognition of inspection conclusions are also discussed.
Requirements to comply with EMA’s policy on the publication of clinical data are the topic of other two newly published guidelines. The first one (EMA/90915/2016 Version 1.2, published on April 12th, 2017) provides readers with the last updates on clinical reports submitted as part of other regulatory procedures, informed consent applications and duplicate marketing authorisations.
The guideline discusses also all procedural aspects related to the submission of clinical reports as well as issues related to their anonymisation (with inclusion of a template for the anonymisation report). The identification of commercially confidential information in clinical reports and the redaction of the relative documentation is covered in the last chapter of the guideline, which also provides a Justification table template to be used by the sponsors. An expanded questions-and-answers (Q&A) document (EMA/14227/2017) is also available to assist the interested companies in the drafting of applications.