On 25th October, the MHRA opened a consultation period of 12 weeks for their review and consolidation of UK legislation pertinent to manufacture and use of medicines. Many requirements relating to the creation, management and retention of medical records are covered by the regulations within scope. However, an initial review of the proposed changes do not appear to reveal anything specifically about this topic.
Of note, the requirements for clinical trials is explicitly excluded from this exercise. The consultation document states:
“There are ongoing negotiations at a European level about the introduction of a Directive that would require substantial changes to the regulation of clinical trials. In addition, on 23 March the Chancellor of the Exchequer announced that the Government will review the UK’s implementation of the Clinical Trials Directive in order to reduce perceived gold-plating and to increase the proportionality of the system. We intend to leave the existing UK legislation regulating clinical trials as it is for the moment, rather than consolidate it now and then amend it substantially not long afterwards.”
Those records managers with an interest in GCP records need to look out for the subsequent review