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13.01.2025
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30 years BfArM
30 years BfArM
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01.07.2025
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Advice
The new application form for advice has been online since July 1, 2025. It bundles all advice procedures offered by BfArM and Paul-Ehrlich-Institut on a central platform.
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27.01.2025
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Advisory Council for Delivery and Supply Shortages
According to section 52b subsection 3b of the Medicinal Products Act, the Federal Institute for Drugs and Medical Devices is empowered to set up an Advisory Council to continuously monitor and evaluate the overall supply situation in Germany.
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20.05.2025
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Agenda Iris User Group Meeting
Agenda Iris User Group Meeting
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30.06.2025
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Agenda: PDU-Workshop
Path(s) to transform your research into a product candidate
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03.02.2025
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AMIce - Public Part - Module Batch Release
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Medicinal Products
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the comprehensive medicinal products information system AMIce, managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Substances
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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03.02.2025
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AMIce - Public Part - Module Terms for Substances
AMIce - Öffentlicher Teil (AMIce-Public Part) contains parts of the Federal Drug Application Database (AmAnDa), which is maintained and updated by the German drug regulatory authorities BfArM, BVL, and PEI.
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27.06.2025
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Angusta (misoprostol for induction of labour): Reports of overdose and contraindicated use with labour already in progress
Active substance: misoprostol
Reminder of the authorisation-compliant application.
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16.01.2025
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Application Process
DACO has a broad range of responsibilities related to data access applications
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20.06.2025
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Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025
The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.
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23.05.2025
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Azithromycin: re-evaluation of the benefits and risks
Active substance: azithromycin
The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommends changes with regard to the use of the antibiotic azithromycin.
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11.07.2025
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CAMD and HMA: European medical device competent authorities statement on reform of the EU regulatory framework for medical devices (July 2025)
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18.06.2025
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Capacity building at its best: seeding and harvesting
This report highlights two key milestones: the recent manual workshop in Tanzania and the first continental clinical assessment training – both of which underscore the fellowship's commitment to capacity-building and harmonization across the African continent.
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12.05.2025
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CHMP Committee for Medicinal Products for Human Use
CHMP Meeting Highlights for May 2025
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12.05.2025
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CHMP Meeting Highlights April 2025
CHMP Meeting Highlights April 2025
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09.01.2025
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CHMP Meeting Highlights December 2024
CHMP Meeting Highlights December 2024
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07.03.2025
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CHMP Meeting Highlights February 2025
CHMP Meeting Highlights February 2025
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13.02.2025
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CHMP Meeting Highlights January 2025
CHMP Meeting Highlights January 2025
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