GMP News - Regulatory Affairs

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 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.

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.

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®.

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.

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.