GMP News Drug Safety/Pharmacovigilance

16.04.24

ICH E2D(R1) Draft Guideline on Post-Approval Safety Data

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

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16.04.24

FDA issues Draft Guidance on Key Information in Informed Consent

The FDA published a draft guidance on key information in informed consent. Comments are due by 30 April 2024.

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16.04.24

How to Notify the MHRA of Changes to the PV System

The MHRA published guidance updates on how to notify the MHRA about changes to the Pharmacovigilance (PV) system. The revisions came into effect on 11 May 2023 and have been updated on 17 November 2023.

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10.04.24

US FDA: Draft on Data Integrity for BE/BA Studies published

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

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14.03.24

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.

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14.03.24

Improving Registration and Reporting Summary Results Information for Clinical Trials

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.

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14.03.24

Master Protocols for Drug and Biological Product Development

A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.

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21.02.24

EMA/HMA/ECA: List of Active Substances defined to prevent supply bottlenecks

As part of the measurements against supply shortages in the pharmaceutical sector, the first version of the "Union list of critical medicines" and further information on this was published on the EMA website at the end of last year. This list contains more than 200 active substances that are considered critical in the event of a supply shortage and whose shortage must be avoided at all costs.

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13.02.24

EMA: FAQs for the Use of IRIS

In January, the question and answer catalogue "RPM for PLM (Regulatory Procedure Management for the Product Lifecycle Management) - Frequently Asked Questions and Answers" was published on the EMA website. In addition to the glossary, it contains 23 questions and their answers relating to the use of the IRIS system.

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08.02.24

FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products

Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.

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25.01.24

Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.

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25.01.24

FDA Exception from the Requirement to obtain Informed Consent

The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the participants.

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25.01.24

EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

Following a good clinical practice (GCP) inspection which showed irregularities in study data, the EMA has recommended the suspension of marketing authorizations of a number of generic medicines tested by a contract research organisation (CRO) located in India.

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23.01.24

FDA Publication on Elemental Impurities in Cannabis following Vaporization

Following the previously issued article on microbial contamination, authors from the FDA recently published an article on elemental impurities in cannabis following vaporization. The results indicate that a transfer of heavy metals from cannabis material to cannabis vapor may not occur during the vaporization process under the applied study conditions.

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17.01.24

Ozempic Falsification also in the US

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.

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