GMP News - Pharmaceutical Development / Clinical Trials / GCP
GMP News - Pharmaceutical Development / Clinical Trials / GCP
16.08.22
FDA offers "Snapshot" Feature for Clinical and Development Guidelines
Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?
Extended Input Deadline for USP´s new Chapter on Quality Considerations for Cannabis
Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.
Benefit-Risk Assessment for Product Quality Evaluation
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.
Since May 2022, the new version of the "IRIS guide for applicants" is available on the EMA website. Besides formal adaptations, version 2.10 contains additions in chapter 7 and updates in chapters 2 and 6.
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
In order to support sponsors, clinical investigators and applicants in planning and conducting complex clinical trials (CCTs), a new Q&A document covering this topic has now been published on the European Commission (EC) website. What is a complex clinical trial?
Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
Clinical Trials Regulation - Version 6.1 of the Q&As
The European Commission published an updated version of the Questions & Answers document relating to the EU Clinical Trials Regulation. What are the GMP consequences of switching the regulatory framework applicable to a clinical trial?
USP Announces Chapter Elaboration on Quality Considerations for Cannabis
The USP Expert Committee on Botanical Dietary Supplements and Herbal Medicines announced the elaboration of a new general chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research. The input deadline for comments is 30 June 2022.
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.
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.
The EMA published guidance for applicants / MAHs involved in GCP inspections. It includes a detailed list of documents to be provided to GCP inspectors.
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.
The EMA has published the "Guideline GVP Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation.