GMP News - Pharmaceutical Development / Clinical Trials / GCP

28.09.23

FDA issues Final Guidance on Informed Consent

The U.S. Food and Drug Administration (FDA) issued the final document, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". Amongst others, the guidance clarifies who is responsible for the specific areas related to informed consent that should be considered.

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28.09.23

How to Obtain Data on Populations Underrepresented in Clinical Trials

The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”. The purpose of this document is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products in the postmarketing setting in typically under-represented patient populations in clinical trials.

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28.09.23

EMA's Expectations for updated Investigator's Brochures and Informed Consent Forms

What are the expectations for distribution of updated Investigator's Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites / investigators?

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28.09.23

GCP Inspection Reveals Deficiencies at CRO in India

Critical inspection findings at a study center in India led the European Medicines Agency (EMA) to launch a referral process and to review potential implications for marketing authorizations in Europe. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

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26.09.23

WHO issues draft Guidance on Best Practices for Clinical Trials

The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials.

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26.09.23

New EMA Reflection Paper on the use of Artificial Intelligence

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

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12.09.23

Critical Quality Attributes for Topical Dosage Forms

A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.

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12.09.23

Storage and Transportation of IMPs

The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.

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12.09.23

Clinical Trials Regulation - Version 6.5 of the Q&As

The European Commission (EC) published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation (CTR). In particular, chapter 11 on transitional trials has been deleted and a new guidance document has been developed.

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12.09.23

Best Practice Guide for Transitional Clinical Trials

The Clinical Trials Coordination Group (CTCG) has published a Best Practice Guidance for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the CTD that need to be transitioned to the EU CTR.

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06.09.23

WHO Draft Working Document on Biowaiver Project published for Comments

The World Health Organization (WHO) has published a draft working document entitled WHO Biowaiver Project - Prioritization exercise of active pharmaceutical ingredients for cycle VI (2024) and preliminary results from cycle V (2023). The deadline for submitting comments is 10 September 2023.

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24.08.23

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

The FDA issued a new guidance to provide general considerations to sponsors developing psychedelic drugs for medical use. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs. This is the first FDA guidance that presents considerations for designing clinical trials for psychedelic drugs.

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24.08.23

Can Sponsors Contract Service Providers for Investigator Tasks?

The sponsor may support the investigator by contracting service providers. However, it is emphasized that the investigator is still responsible for any outsourced tasks.

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24.08.23

Can Productivity Applications be Used in Clinical Trials?

EMA's GCP Inspectors Working Group added a new Question & Answer relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As. What are the Expectations for Productivity Applications used in Clinical Trials?

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24.08.23

Semisolid Drug Product Quality and Performance Tests

The USP adopted the revised general chapters <1724> Semisolid Drug Products - Performance Tests and <1912> Measurement of Yield Stress of Semisolids. In particular, chapter <1724> now also includes information on in vitro permeation tests (IVPTs).

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