GMP News - Pharmaceutical Development / Clinical Trials / GCP

04.07.23

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.

20.06.23

ICH GCP Draft Guideline

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.

20.06.23

How to Deal with Changes to Third-Party Vendors?

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.

06.06.23

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.

06.06.23

FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

The U.S. Food and Drug Administration (FDA) published the final Q&A paper on a risk-based approach to monitoring of clinical trials.

06.06.23

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).

16.05.23

USP Publishes Draft on Quality Requirements for Cannabis

The USP previously announced to elaborate a chapter on quality considerations for Cannabis. Now the draft chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research has been published in PF 49.3. Comments can be sent to the USP until end of July.

04.05.23

MHRA's GCP Inspection Metrics

The MHRA published their GCP Inspections Metrics Report, covering the period from 1 April 2019 to 31 March 2020. Critical observations were related e.g. to data integrity, IMP management, protocol compliance, and pharmacovigilance.

04.05.23

FDA's Framework for Decentralized Clinical Trials

Following the previously published FDA guidance on externally controlled trials, the agency issued a Framework for the use of Digital Health Technologies (DHT).

03.05.23

EMA adds Disclaimer to the Reflection Paper on the Use of IRTs

The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).

02.05.23

Major Reform of UK Clinical Trials Regulation

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

02.05.23

EMA's Q&As on Raw Data from Clinical Trials

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

02.05.23

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.

18.04.23

FDA's Guidance on Quality Considerations for Clinical Research with Cannabis

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.

11.04.23

Manufacture of IMPs - When is it Reconstitution?

Following the Brexit, the UK clinical trials regulations differ from those in the EU Member States. Therefore, the British MHRA published on their blog a post on the manufacture of Investigational Medicinal Products (IMPs).

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GMP News - Pharmaceutical Development / Clinical Trials / GCP

EMA starts Review of Transparency Rules for the CTIS

ICH GCP Draft Guideline

How to Deal with Changes to Third-Party Vendors?

EMA issues Reflection Paper on Demonstrating Efficacy for Advanced Therapies

FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

Good Machine Learning Practice: FDA issues Discussion Paper on AI/ML in Drug Development

USP Publishes Draft on Quality Requirements for Cannabis

MHRA's GCP Inspection Metrics

FDA's Framework for Decentralized Clinical Trials

EMA adds Disclaimer to the Reflection Paper on the Use of IRTs

Major Reform of UK Clinical Trials Regulation

EMA's Q&As on Raw Data from Clinical Trials

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

FDA's Guidance on Quality Considerations for Clinical Research with Cannabis

Manufacture of IMPs - When is it Reconstitution?

Recommended Event

Dissolution Testing Development / Quality Control and in vivo Relevance

GMP News - Pharmaceutical Development / Clinical Trials / GCP

EMA starts Review of Transparency Rules for the CTIS

ICH GCP Draft Guideline

How to Deal with Changes to Third-Party Vendors?

EMA issues Reflection Paper on Demonstrating Efficacy for Advanced Therapies

FDA Publishes Final Q&A Paper on Risk-Based Monitoring of Clinical Trials

Good Machine Learning Practice: FDA issues Discussion Paper on AI/ML in Drug Development

USP Publishes Draft on Quality Requirements for Cannabis

MHRA's GCP Inspection Metrics

FDA's Framework for Decentralized Clinical Trials

EMA adds Disclaimer to the Reflection Paper on the Use of IRTs

Major Reform of UK Clinical Trials Regulation

EMA's Q&As on Raw Data from Clinical Trials

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

FDA's Guidance on Quality Considerations for Clinical Research with Cannabis

Manufacture of IMPs - When is it Reconstitution?

Recommended Event

Dissolution Testing Development / Quality Control and in vivo Relevance

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