GMP News Drug Safety/Pharmacovigilance

23.11.22

Amendment to the CTR on IMP Labelling

The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.

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15.11.22

FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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08.11.22

EMA publishes ICH M11 (CeSHarP) for Comments

The EMA published the ICH M11 draft Guideline on the Clinical Electronic Structured Harmonized Protocol (CeSHarP) for comments. The comment period runs until February 26, 2023.

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08.11.22

Real-World Data: EMA´s Good Practice Guide

The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.

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08.11.22

FDA launches Real-World Evidence Program

The agency is conducting an Advancing Real-World Evidence Program, which seeks to improve the quality and acceptability of RWE-based approaches in support of new intended labeling claims.

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06.10.22

How to Submit Documents with Real-World Data to FDA

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

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06.10.22

List of Documents Needed during GVP Inspections

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

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06.10.22

FDA´s Implementation Guide for ICH E2B (R3)

The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to the agency. Read more about FDA´s regional ICH E2B (R3) Implementation Guideline.

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28.09.22

EMA: New Update of the "IRIS" Documents

In September 2022, the documents "IRIS guide for applicants" and "IRIS guide to registration and RPIs" were updated again - now containing some innovations and revisions.

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20.09.22

Charging for IMPs? FDA has some Answers

The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

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20.09.22

FDA publishes Answers to GCP Questions

The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?

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20.09.22

Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

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14.09.22

ANVISA´s Q&A on Medical Cannabis for Clinical Investigations

The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?

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13.09.22

FDA's recommended Font and Font Size for Instructions for Use Labeling

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?

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13.09.22

UK changes SUSAR Reporting for IMPs

The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.

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