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GMP News

Real-World Data Requirements for Herbal Medicinal Products

A scientific article in the style of a white paper has been published in the journal Planta Medica. The paper on requirements for the description of herbal preparations included in real-world data (RWD) publications concludes that a precise description of herbal drugs, herbal drug preparations and HMPs is essential for the use of RWD for regulatory decisions.

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FDA: ANDA Guidance for Industry published

In September 2024, the U.S. FDA published Revision 1 of the Guidance for Industry 'Amendments to Abbreviated New Drug Applications Under GDUFA'. This describes how amendments can be made by applicants for ANDAs (Abbreviated New Drug Applications) and PASs (Prior Approval Supplements).

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EMA: Update of the Q&A Documents for "Centralised Procedures"

In October 2024, the Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures - for topics before and during the application as well as for questions after the granting of marketing authorisation - were again updated and published on the website of the European Medicines Agency (EMA).

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