ICH: Assembly Meeting 2024 Recap

15.11.2024

News

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24.11.2025

Question of the Week

How is a QRM process initiated?

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FDA: Updated Pre-RFD Guidance for Combination Products

21.11.2025

News

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

21.11.2025

News

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.

18.11.2025

LOGFILE Feature

Data Integrity and Data Governance

Data integrity is a key element in the pharmaceutical quality assurance system which has gained importance in recent years, especially from the viewpoint of the authorities. In GxP-regulated companies, managers are responsible for identifying and minimising risks to data integrity (“data governance”).

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

14.11.2025

News

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

14.11.2025

News

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

The Environment Committee of the European Parliament has issued its opinion on the proposed EU Regulation to strengthen the availability of critical medicines. Key recommendations include fast-track permitting, simplified environmental assessments, and support for strategic manufacturing projects to boost EU production capacity.