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USP revises Storage and Transport Chapters

The United States Pharmacopeia (USP) is currently introducing various chapters and stimuli articles. Some of these are also relevant for storage and transport activities.

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EMA publishes first two Guidances on Drug Shortages

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

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Hard Brexit: MHRA Preparations

The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.

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How to detect Falsified Medicines

Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.

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New GDP Non-Compliance Reports

New GPD Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA of the inspected companies.

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FDA Blockchain Pilot

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.

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Version 15 of the Q&As on Safety Features

The European Commission published version 15 of the Q&A´s on Safety features for medicinal products for human use. The new version includes a revision of the Q&A on safety features relating to IMPs.

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Safety Features - how is it progressing?

The MHRA will be issuing a series of blog posts regarding the implementation of the FMD over the next few months. The first post looks at the robustness of incoming checks.

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Defect Catalog for Films and Foils

A technical guide on commonly used insulation materials has recently been provided in form of a stimuli article in Pharmacopeial Forum. In particular, a defect catalog for common thermal system components with detailed examples of potential failures is provided.

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New Zealand proposes new legislation for medical cannabis

New Zealand released a proposed regulatory approach for medical cannabis. The implementation of the medical cannabis program is anticipated to start in the first quarter of 2020. In addition, the document proposes two options for GMP.

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