GMP News - Pharmaceutical Development / Clinical Trials / GCP
GMP News - Pharmaceutical Development / Clinical Trials / GCP
27.07.23
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.
USP-NF Stimuli Article on Chromatographic Screening for Extractables and Leachables
In the Pharmacopeial Forum, PF 49(4), a stimuli article entitled "Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables" was published.
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®.
Potential Assays for Monoclonal Antibodies and Other Therapeutic Proteins
The FDA recommends and provides guidance on potency assays for monoclonal antibodies and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. The purpose of this FDA guidance is to assist in the development and implementation of such assays to ensure adequate information on efficacy throughout the shelf life of the product.
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.
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.
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.