GMP News - Pharmaceutical Development / Clinical Trials / GCP

18.05.22

Data Protection of Information Uploaded in the CTIS

To assist sponsors and authorities in fulfilling the transparency requirements set out in the Clinical Trials Regulation, the EMA is preparing a dedicated guidance on the protection of personal data in the CTIS. The agency has published a public consultation document to allow for wider stakeholder input.

more

18.05.22

Clinical Trials - ICH E11A on Pediatric Extrapolation

The ICH E11A draft reached Step 2 of the ICH process. The guideline describes the extrapolation framework consisting of the pediatric extrapolation concept and the pediatric extrapolation plan.

more

18.05.22

List of Documents Needed during GCP Inspections

The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.

more

11.05.22

How to Demonstrate Comparability of Analytical Procedures

A new Ph. Eur. Chapter 5.27. Comparability of alternative analytical procedures has been proposed in Pharmeuropa 34.2. The comment deadline is 30 June 2022.

more

10.05.22

What is a Pregnancy Prevention Programme?

The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.

more

27.04.22

Requirements for Styrene Block Copolymers

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.

more

26.04.22

Product Transfer: Is a Transfer Plan a required GMP Document?

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

more

06.04.22

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.

more

05.04.22

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.

more

05.04.22

Recent Findings in GCP Inspections

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.

more

05.04.22

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.

more

16.03.22

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?

more

16.03.22

Revision of the PIC/S GMP Guide

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.

more

15.03.22

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.

more

15.03.22

Remote Data Acquisition in Clinical Trials

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?

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics