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.
Generally Accepted Scientific Knowledge in Drug Applications
The FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. Therefore, the agency published a draft guidance which describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications.
The FDA published a draft guidance on decentralized clinical trials (DCTs). Examples of decentralized elements include obtaining laboratory tests at a local facility rather than a research medical center or conducting a clinical follow-up visit in the trial participant's home.
EMA starts Review of Transparency Rules for the CTIS
The European Medicines Agency had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023.
Northern Ireland: EU Regulation with specific Rules published
An EU Regulation laying down specific rules for medicinal products for human use for Northern Ireland has been published in the Official Journal of the EU. It mainly concerns importation into NI and safety features.
News on the Windsor Framework for Medicines Supply in Northern Ireland
The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.
The ICH E6(R3) draft Guideline on Good Clinical Practice (GCP) is now available for public consultation. It intends to encourage the use of innovation and technologies that have the potential to make clinical trials more efficient.
The FDA is requesting feedback on factors the agency should consider when reviewing proposed modifications to a risk evaluation and mitigation strategy (REMS) that are prompted by or related to changes in third-party vendors, also known as REMS administrators.
USP <88> "Biological Reactivity Tests, In Vivo" is currently also undergoing Revision
In the course of the revision of the Chapter on biological reactivity the USP has also published a draft of chapter <88> on in vivo tests. This news presents a summary of the changes.
Updates to the EMA Q&A Documents on Centralised Procedures
In April 2023, the Questions & Answers documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.
EMA issues Reflection Paper on Demonstrating Efficacy for Advanced Therapies
The European Medicines Agency (EMA) has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials (SATs) for new therapies. According to the agency, this is the first guidance issued by an international medicine regulator articulating the considerations and challenges associated with this type of clinical trials.
Good Machine Learning Practice: FDA issues Discussion Paper on AI/ML in Drug Development
The U.S. Food and Drug Administration (FDA) issued a discussion paper on "Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products." In particular, the FDA wants to receive feedback on the key areas in the context of AI/ML, including Good Machine Learning Practice (GMLP).