GMP News - Regulatory Affairs

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FDA's Draft Guidance on Postmarketing Noncompliance

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials,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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26.07.23

EDQM: Excipient Monographs

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.

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25.07.23

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.

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25.07.23

Do you know DARWIN?

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®.

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25.07.23

EMA: New Update of the Q&A Documents on Centralised Procedures

Once again, the Questions & Answers documents with regard to centralised marketing authorisation procedures have been revised and published on the European Medicines Agency (EMA) website in June 2023. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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25.07.23

CEP 2.0: Insights into Inspection Reports

As part of the implementation of the new "CEP 2.0", the EDQM has now published on its website a list of authorities and organizations that have insight into inspection and assessment reports.

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