GMP News - Regulatory Affairs

10.03.23

CTIS & CTR: Sponsor Questions & Answers

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.

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10.03.23

CTR & CTIS: Quick Guide for Sponsors

A quick guide on the main rules and procedures of the Clinical Trials Regulation (CTR) has been released for sponsors who wish to conduct clinical trials in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region.

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10.03.23

CTIS: Questions and Answers on Data Protection

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection. The Q&A document has been created to provide guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS.

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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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08.03.23

Brexit: Agreement on Northern Ireland Protocol also with Consequences for Medicines

The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.

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08.03.23

EDQM: Supplement 11.2 of the European Pharmacopoeia available

Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.

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01.03.23

EDQM: Updated List of Reference Substances

On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).

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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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16.02.23

Pyrogenicity Testing - European Pharmacopoeia continues to be updated

The European Directorate for the Quality of Medicines published a new chapter 5.1.13. PYROGENICITY, dealing with testing for pyrogens, for comment.

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15.02.23

Warning Letter and Recall of a homeopathic Medicine for Children

FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

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15.02.23

Swissmedic only issues WHO Certificates in Accordance with the new Format

From 20 March 2023, Swissmedic will issue CPPs in the new WHO format. No CPP orders can be accepted during the transition to the new format.

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08.02.23

FDA concludes that existing Regulatory Framework is not applicable for CBD

The U.S. FDA has concluded that a new regulatory pathway for CBD is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

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08.02.23

CEPs: EDQM establishes New Procedure

The EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" by the end of 2022 and has now published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia).

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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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