GMP News - Regulatory Affairs

11.04.23

Final GCP Guideline on Computerized Systems and Data Integrity

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.

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05.04.23

Laboratory Data Integrity issues once again caused a Warning Letter

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

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05.04.23

FDA Stops Voluntary Cosmetic Registration Program

The FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023. This follows the agency's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act" (MoCRA). According to the agency, the new law gives the FDA new authorities that will help ensure the safety of cosmetic products.

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22.03.23

EDQM: New CEP 2.0

The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM. The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.

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14.03.23

Recommendations on Decentralized Elements in Clinical Trials

The EU Commission has supplemented the area of clinical trials with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers.

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14.03.23

CTIS: EMA´s Risk Mitigation Plan

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

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10.03.23

Consultation on Multi-Stakeholder Platform for improving EU Clinical Trials

The EMA published a Concept Paper and a Press Release on a multi-stakeholder platform to support discussions in the clinical research landscape. The deadline for comments is 3 March 2023.

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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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