GMP News - Pharmaceutical Development / Clinical Trials / GCP

25.01.23

ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis

The EMA published an updated Q&A document regarding the new ICH M10 guideline on Bioanalytical Method Validation and Study Sample Analysis. The document became effective on 21 January 2023.

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18.01.23

USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development

In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.

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18.01.23

ANVISA authorizes National Scientific Research with Cannabis

The agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.

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18.01.23

Update on the EMA Checklists for Changes & Variations

The European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated.

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17.01.23

Clinical Trials: EMA clarifies Dates for the Transition Period

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. Following the previous update on how to manage clinical trials transitioned to the CTR, the EMA now clarifies the timelines for the transition period.

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17.01.23

How to Manage Clinical Trials Transitioned to the CTR?

In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised version 3 has now been published.

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17.01.23

Sponsor Responsibilities with regard to Handling and Shipping of IMPs

Following the entry into application of the CTR at the beginning of last year, the final version of the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs" has been published. IMPs may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in this guideline.

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17.01.23

Update on the EMA Guidance for Applicants/MAHs involved in GCP Inspections

The EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA. By this revision only the GCP section of the document has been amended. Amongst others it has been clarified that the reporting inspector should be contacted prior to submitting any documents.

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13.12.22

Clinical Trials Regulation - Version 6.2 of the Q&As

The European Commission published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation. What are patient facing documents and how are these documents expected to be submitted ?

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13.12.22

EMA Evaluates Access to Raw Data from Clinical Trials

The EMA started a pilot to assess whether using raw data can help speed up and improve the medicine-evaluation process. Read more about EMA´s Proof-of-Concept Pilot.

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13.12.22

EMA publishes 2020 / 2021 GCP Annual Reports

Following the delayed 2019 Annual Report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) published earlier this year, the EMA released the 2020 and 2021 annual GCP reports. An increase in findings related to computer systems is noted compared to the last reports.

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13.12.22

Expanded Access to IMPs: FDAs Questions & Answers

The FDA published a revised draft guidance on frequently asked questions about the agency´s regulation of expanded access to investigational medicinal products. But, what exactly is expanded access?

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13.12.22

Amendment to the CTR on IMP Labelling

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.

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29.11.22

Real-World Data: EMA´s Good Practice Guide

The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.

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29.11.22

FDA launches Real-World Evidence Program

The agency is conducting an Advancing Real-World Evidence Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims.

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