Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.
ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation
On March 24, the drafting process of the new ICH Guideline Q14 Analytical Procedure Development and the revised Guideline Q2(R2) Validation of Analytical Procedures reached Step 2, and both were published for consultation by ICH members.
MHRA GCP Inspector´s Experience during the COVID-19 Pandemic
The MHRA GCP Inspectors provided insight in their experience during the COVID-19 Pandemic. Although they have their limitations, remote GCP inspections have proven to be very effective and critical findings have been identified.
The EMA published the Annual report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) containing examples of findings observed during recent GCP inspections. In addition, the 3-year work plan for the GCP IWG has been released.
Version 5 of the Q&As regarding the Clinical Trials Regulation
What is the final deadline for submission of a clinical trial according to the former CTD rules? The European Commission published an updated Version 5 of the Questions & Answers relating to the CTR which came into application on 31 January 2022. The revision includes new Q&As regarding arrangements for the transitional period.
UK: Public Consultation on new Clinical Trials Legislation and Impact on IMPs
Following the start of the application of the EU CTR on 31 January 2022, the MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Will the UK align with the EU CTR requirements, e.g. regarding labelling of IMPs?
The PIC/S (Pharmaceutical Inspection Co-operation Scheme) already published a new version of its GMP Guide PE016 in February. This is due to the revision of the EU regulation on clinical trials. There is also a new annex on certification by a Qualified Person and batch release.
Updated Guidance relating to Clinical Trials during the COVID-19 Pandemic
The Guidance on the management of clinical trials during the COVID-19 Pandemic has been updated. The key changes are relating to updates with references to the EU Clinical Trials Regulation (CTR) which entered into application on 31 January 2022.
The FDA provides recommendations for sponsors, investigators, and other interested parties on the use of digital health technology for remote data acquisition in clinical trials. What is required regarding software validation and electronic documents?
The reflection paper on the use of interactive response technologies (IRT) has been updated in view of the entry into application of the EU Clinical Trials Regulation (CTR) on 31 January 2022. It clarifies that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR.