GMP News Drug Safety/Pharmacovigilance

The MHRA published their GCP Inspections Metrics Report, covering the period from 1 April 2019 to 31 March 2020. Critical observations were related e.g. to data integrity, IMP management, protocol compliance, and pharmacovigilance.

Following the previously published FDA guidance on externally controlled trials, the agency issued a Framework for the use of Digital Health Technologies (DHT).

The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

Following the Brexit, the UK clinical trials regulations differ from those in the EU Member States. Therefore, the British MHRA published on their blog a post on the manufacture of Investigational Medicinal Products (IMPs).

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.