GMP News - Regulatory Affairs

04.05.23

MHRA's GCP Inspection Metrics

The MHRA published their GCP Inspections Metrics Report, covering the period from 1 April 2019 to 31 March 2020. Critical observations were related e.g. to data integrity, IMP management, protocol compliance, and pharmacovigilance.

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04.05.23

New Definition of Pharmaceutical Grade Plastic Packaging Materials

The proposed USP General Chapter <1031> The Biocompatibility of Pharmaceutical Packaging Systems and their Materials of Construction has been published for comment in the current issue of Pharmacopeial Forum. It outlines a risk-based approach to biocompatibility evaluation.

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04.05.23

FDA's Framework for Decentralized Clinical Trials

Following the previously published FDA guidance on externally controlled trials, the agency issued a Framework for the use of Digital Health Technologies (DHT).

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03.05.23

GMP Update: Consequences from the New EU Commission Proposal

The EU Commission has published the proposal for the revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. There are also GMP-relevant changes.

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03.05.23

EMA adds Disclaimer to the Reflection Paper on the Use of IRTs

The European Medicines Agency added a disclaimer to the Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates to address its applicability regarding the European Clinical Trials Regulation (CTR).

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02.05.23

Major Reform of UK Clinical Trials Regulation

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

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02.05.23

EMA's Q&As on Raw Data from Clinical Trials

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

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02.05.23

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.

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26.04.23

USP Draft Chapters for Glass and Plastic Packaging Systems

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

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18.04.23

St. John's Wort: Updated EU Herbal Monograph

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

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18.04.23

Declaration of Herbal Substances & Herbal Preparations in HMPs

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).

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11.04.23

Manufacture of IMPs - When is it Reconstitution?

Following the Brexit, the UK clinical trials regulations differ from those in the EU Member States. Therefore, the British MHRA published on their blog a post on the manufacture of Investigational Medicinal Products (IMPs).

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11.04.23

Clinical Trials Regulation - Version 6.4 of the Q&As

The European Commission published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). A new Q&A has been added for the case where the sponsor of a clinical trial is not the product owner of the IMP and should not have access to the quality IMPD in order to protect commercially confidential information.

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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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