GMP News - Regulatory Affairs

30.08.23

The possible Impact of Artificial Intelligence on the Role of the Qualified Person

Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.

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30.08.23

Renewed Revision of the Q&A Document on Nitrosamine Impurities: temporary acceptable intakes no longer need to be set

The passages amended in the last update of the Q&A document of the EMA/CMDh refer, among other things, to the no longer required setting of temporary acceptable intake limits for nitrosamines. This has important consequences for marketing authorisation holders for the feedback of nitrosamine impurities to the authorities.

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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FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs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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23.08.23

CMDh/HMA: Best Practice Guide on Variations

In July 2023, individual chapters of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" were updated and published on the HMA (Heads of Medicines Agencies) website.

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16.08.23

EDQM: Supplement 11.3 to the European Pharmacopoeia available

Supplement 11.3 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 January 2024. According to the EDQM timetable, this supplement will be followed by versions 11.4 to 11.8, with the final implementation date planned for July 2025.

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09.08.23

EDQM: Nitrosamines and CEPs

As recently reported in our News, the Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" has been updated again. The EDQM has now defined the resulting measures for CEP holders and listed them in its Newsroom.

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09.08.23

FDA's Draft Guidance on Postmarketing Noncompliance

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). In case of PMR Noncompliance the MAH could be subject to an FDA warning letter.

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02.08.23

The New Annex to EMA's Question and Answer Document on the Determination of Acceptable Intake Levels of Nitrosamines

EMA's Q&A document has been extensively revised and supplemented with regard to the limits for nitrosamine impurities. The new Annex 2 describes the approach for determining acceptable intake levels for nitrosamines without data from in vivo mutagenicity studies.

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27.07.23

Remote Access to Study Data in Clinical Trials - What needs to be considered

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?

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27.07.23

FDA's Technical Conformance Guide for Study Data

The Technical Conformance Guide provides specifications, recommendations, and general considerations to sponsors and applicants on how to submit study data in a standardized electronic format.

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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.

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27.07.23

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.

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