GMP News Drug Safety/Pharmacovigilance

10.03.23

EU Survey on the Implementation of the Clinical Trial Regulation

On 31 January 2023 the Clinical Trials Information System has become mandatory for EU clinical trial applications. However, there are still some issues regarding the functionality of the CTIS. Now, the European Commission, together with the EMA and the HMA, published the results of a consultation on the implementation of the CTR.

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10.03.23

Clinical Trials Regulation - Version 6.3 of the Q&As

The European Commission published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation. The revised version includes a new Annex with information on where sponsors can find national requirements.

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22.02.23

EMA's Q&A on Medicinal Cannabis & Call for Scientific Data

The HMPC adopted a Question & Answer (Q&A) document regarding medicinal products. The document aims to clarify the basic regulatory requirements for stakeholders that may not have extensive experience with the EU pharmaceutical regulatory system. In addition, the EMA started a call for scientific data in order to establish an EU herbal monograph.

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02.02.23

Updated ICH E2B(R3) Q&As on ICRs

The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.

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02.02.23

Dosage versus Dose

The U.S. FDA published a draft guidance on the dosage and administration labeling section for certain medicinal products. The guidance is one of several FDA guidance documents addressing labeling for human prescription drugs.

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02.02.23

Format and Content of a REMS Document

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.

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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

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

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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