GMP News Drug Safety/Pharmacovigilance

22.09.21

FDA´s final Q&As on Field Alert Reports

The FDA recently finalized the guidance on expectations for submitting Field Alert Reports (FARs) for potentially defective drugs. The final document supersedes a draft guidance that was issued in July 2018.

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16.09.21

Consultation on Amendments on Pharmacovigilance Activities

A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities has been published on the EC website. The Regulation outlines the practical details on the performance of pharmacovigilance activities to be respected by MAHs, national competent authorities and the EMA.

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16.09.21

Signal Management: EMA and EC agree to further extend the Pilot

The EMA and the European Commission have agreed to further extend the pilot on signal detection in EudraVigilance by marketing authorization holders until the end of 2022. MAHs with APIs included in the EMA list of active substances and combinations involved in the pilot should continue to monitor them in EudraVigilance.

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16.09.21

EMA supports use of global Track & Trace Systems

The EMA supports recommendations for the use of global track & trace systems to mitigate the risk of drug shortages and fight against falsified medicines. To date, track & trace systems have been designed and implemented with a local or regional focus, without taking into account whether they can exchange information with other systems.

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15.09.21

Record Number of Fake Drugs seized during INTERPOL Operation

During an action week coordinated by INTERPOL against illegal internet trade checks led to the discovery of very large numbers of fake and illicit drugs. Overall the operation resulted in the seizure of around 9 million medical devices and illicit pharmaceuticals.

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15.09.21

EMA Update of the Q&As on Herbal Medicinal Products

The updated EMA document "Regulatory Q&A on herbal medicinal products" contains several revised Q&As including the Q&As regarding the requirements for the simplified registration procedure.

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08.09.21

EMA adopts final Public Statement on Pyrrolizidine Alkaloids

The HMPC adopted the final Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination with PAs. Amongst others, it is stated that PA specifications are no longer considered necessary for essential oils.

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11.08.21

FDA Analyses Products from Amazon and Finds Potentially Harmful Drug Ingredients

The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.

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23.06.21

EUDAMED - Current Status of the Database for Medical Devices

The European Commission published Questions & Answers on 26 May 2021, the day of application of Regulation 2017/745 for medical devices. The Questions & Answers are related to the requirements and tools for the safety of medical devices, including EUDAMED.

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16.06.21

New Version of the Q&As on Safety Features for Track & Trace

The European Commission has published Version 18b of the "Questions & Answers" on safety features. In particular the update took into account the new ISO standard for Packaging Tamper verification features.

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09.06.21

Herbal Drugs - What is Well-Established Use?

Herbal medicinal products can be registered via the well established use approach within the EU. But what is needed for the simplified registration and how to demonstrate well established use?

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02.06.21

Medical Cannabis in Greece

Greece is currently discussing a new bill about medical cannabis products. Its purpose is to allow medical cannabis companies in Greece to produce medical cannabis and export it to Europe.

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01.06.21

Recall of Product Samples from U.S. Market Due to Improper Storage Temperature Conditions

A global healthcare company is voluntarily recalling 1,468 product samples from the U.S. market because they were stored at temperatures below storage requirements. The products affected are used to lower blood glucose levels in people with diabetes. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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19.05.21

ICH E6 GCP Guideline: Updated GMP for IMP Principles

The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs. 

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18.05.21

What are the requirements for an eCRF?

What is an eCRF? The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms). In addition they listed several findings from current GCP inspections.

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