Welcome to the Federal Institute for Drugs and Medical Devices
The English web pages of the Federal Institute for Drugs and Medical Devices contain selected items from its German language site. The focus is on information giving an overview about the tasks and aims of the institute. Departments and units are introduced and provide an overview on their scientific work. Additional information is available at the respective German internet sections. The English site will be continuously expanded.
Search results 41 to 60 from a total of 73 (4 pages).
| Date | Title | Link |
|---|---|---|
| 2012.07.30 |
Non CE-marked portable dental X-ray units MHRA has issued Medical Device Alert MDA/2012/046 regarding non CE-marked portable dental X-ray units and recommends to stop using this. |
to article |
| 2012.06.21 |
Publication of the results of clinical trials in accordance with Section 42b AMG BfArM has updated the procedural advice on the reqiurements regarding the publication of the results of clinical trials in accordance with Section 42b of the German Medicinal Products Act |
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| 2012.02.03 |
PARTICIPATION of BfArM at the COMMON EU SUBMISSION PLATFORM (CESP) PROJECT BfArM joins the ‘extended Proof of Concept’ for the CESP Project aiming to establish a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the EEA. |
to article |
| 2012.02.02 |
BfArM’s updated assessment concerning oxygen concentrators Survey on the updated recommendation addressed to the local competent authorities concerning oxygen concentrators |
to article |
| 2011.12.06 |
Annual Safety Reports as Development Safety Update Reports (DSUR) Answers to frequently asked questions regarding the new form of annual safety report, the DSUR, have been harmonised on the European level by the Clinical Trial Facilitation Group (CTFG). |
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| 2011.12.02 |
GMP issues with the contract manufacturer Ben Venue Laboratories (BVL), Ohio, USA: Effects on clinical trials of medicinal products Effects on clinical trials with medicinal products containing one of the following active ingredients: anidulafungin, PEG-L-asparaginase, azacitidine, aztreonam, bivalirudin, bortezomib, busulfan, carmustine, cidofovir, eculizumab, histamin hydrochloride, mifamurtide, liposomal doxorubicin, hexaminolaevuniate, oxaliplatin, perflutren, raltitrexed, ribavirin, romidepsin, temsirolimus, telavancin, tetrakis (2-methoxy isobutyl isonitrile) copper (I) tetrafluoroborate |
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| 2011.11.16 |
Bankruptcy of NMT Medical Swissmedic advises to cease the use of septal repair devices that have been produced by the manufacturer NMT Medical, Inc. |
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| 2011.09.28 |
BfArM’s assessment concerning oxygen concentrators Survey on the recommendation addressed to the local competent authorities concerning oxygen concentrators |
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| 2011.06.28 |
Update of FAQs regarding e-submissions Please note that the FAQ list on issues related to e-submissions has been updated. |
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| 2011.05.11 |
Update of BfArM eValidator (software for technical validation of e-submissions) The new Service Pack integrates the validation criteria updated on the European level into the eValidator. |
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| 2011.01.13 |
National Variations National Variations – News Types of changes to be used in the national Variation form (structural numbers and texts), thematically arranged.
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| 2011.01.10 |
Advice on Harmonisation of Product Information Texts for Medicinal Products with Identical Active Substances Advice on Harmonisation of Product Information Texts for Medicinal Products with Identical Active Substances Medicinal products with identical pharmaceutical form and identical composition of active substances in type and quantity |
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| 2011.01.03 |
Update FAQ Regarding the "Sunset Clause" Notification Procedure The BfArM informs that, in accordance with Section 29 sub-section 1b AMG, the marketing authorisation holder shall notify the competent federal higher authority immediately of the date on which the medicinal product is to be placed on the market, taking into consideration the different pharmaceutical forms and strengths authorised. |
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| 2010.09.23 |
BfArM Symposium on ”Multiplicity Issues in Clinical Trials“ The Federal Institute for Drugs and Medical Devices will be holding a symposium on Multiplicity Issues in Clinical Trials on 12 October 2010. |
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| 2010.07.27 |
BfArM recommends not to implant silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) |
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| 2010.06.17 |
„Flying Team“ Pioglitazone – Expiry of data protection on 13.10.2010 The BfArM will, from 13. Oktober 2010, accept generic applications for Pioglitazone 15 mg and 30 mg tablets. Taking into account the number of DCP submission requests already received, the BfArM has decided to open a further „Flying Team“ project aiming at shortened timelines for submission and evaluation. |
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| 2010.06.16 |
Several links have changed on BfArM subpages Please note that the addresses of several links have changed due to a technical update of the underlying content management system. Please check both the bookmarks on BfArM subpages as well as the addresses of the RSS newsfeeds you use. |
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| 2010.05.03 |
eSubmission From 31.03.2010 onwards the Federal Institute for Drugs and Medical Devices will accept to receive nearly paperless electronic-only submissions for new applications for authorisation or registration of medicinal product as well as for post authorisation procedures (e.g. variations, renewals, PSURs) of those medicinal products which have already been submitted under this new rules after 31.03.2010. |
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| 2010.03.10 |
EU Medical Device Vigilance Exchange via xsd XSD's for manufacturers, who wish to report directly from their database into an XML file that fulfils the requirements for electronic reporting. |
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| 2010.02.09 |
Variations On the occasion of the new Variation Regulation (EC) No 1234/2008 which applies since 1 January 2010 a new web page "Variations" has been created and should be considered. |
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