The New Annex to EMA's Question and Answer Document on the Determination of Acceptable Intake Levels of Nitrosamines
EMA's Q&A document has been extensively revised and supplemented with regard to the limits for nitrosamine impurities. The new Annex 2 describes the approach for determining acceptable intake levels for nitrosamines without data from in vivo mutagenicity studies.
Remote Access to Study Data in Clinical Trials - What needs to be considered
EMA's GCP Inspectors Working Group added a new Question & Answer in the section on "Records of Study Subject Data Related to Clinical Trials" of the GCP Q&As. What are the considerations when direct remote access of health data is required in a clinical trial?
The Technical Conformance Guide provides specifications, recommendations, and general considerations to sponsors and applicants on how to submit study data in a standardized electronic format.
Adjusting for Covariates in Randomized Clinical Trials
The FDA has issued a new guidance together with a Guidance Snapshot which describes the agency's current thinking regarding adjusting for covariates in the statistical analysis of randomized clinical trials. According to the FDA, Sponsors should adjust for baseline covariates that are strongly associated with an outcome in a clinical trial population.
ICH Update on GCP related Topics including RWD/RWE
Following the recently published ICH E6(R3) Draft Guideline on Good Clinical Practice (GCP) the ICH announced progress on several new ICH Efficacy Guidelines including the publication of a new ICH Reflection Paper on Real-World Evidence / Real-World Data.
Supplement 11.2 to the European Pharmacopoeia (Ph.Eur.) came into force on 01 July 2023 and contains several updated monographs. These include five updated excipient monographs, which now include the so-called "functionality-related characteristics (FRCs)" section. In total, there are now more than 100 Ph.Eur. Monographs that include this section.
Update on the EMA Guidance on Protection of Personal Data & CCI
The European Medicines Agency (EMA) plans to gradually resume clinical data publication from September 2023, having temporarily suspended this activity. Therefore, the EMA has revised and supplemented the previously published documents on the transfer of personal data and commercially confidential information (CCI) through the CTIS.
The EMA has published a document outlining a framework for establishing Real-world evidence (RWE) data in regulatory decision-making, based on the findings of some 30 studies initiated by the EMA and DARWIN EU®.
EMA: New Update of the Q&A Documents on Centralised Procedures
Once again, the Questions & Answers documents with regard to centralised marketing authorisation procedures have been revised and published on the European Medicines Agency (EMA) website in June 2023. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.
As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.
EDQM: Policy for CEP Applications published for Comments
In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.
COVID-19 Flexibilities also to be terminated in the GMP/GDP Environment
The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.
The EMA has updated its ICH M11 website to include overviews of comments received on the M11 draft documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template.
Interim Guidance on Protection of Personal Data & Commercially Confidential Information
Following the previously published public consultation document on Data Protection of Information uploaded in the CTIS, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS.