News
EMEA: Electronic-only submissions
18.08.2009
As of 12 October 2009 (new procedures without pre-submission meeting) and 19 October 2009 (new procedures with Pre-submission meeting), the EMEA will only accept electronic submissions for
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EMEA: eCTD Plasma Master File guidance
18.08.2009
It is the intention that the eCTD format supports all marketing applications sent to EMEA, and related procedures. By analogy this is applicable also to submission of the Plasma Master File,
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MHRA: MHRA excercise to update product information following European paediatric work-sharing procedures
18.08.2009
Following our announcement on 18 November 2008, requests have now been sent to marketing authorisation (MA) holders for products containing salmon calcitonin and ranitidine where product
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MHRA: Progress review: MHRA best practice guidance for processing national marketing authorisation applications - pilot phase
18.08.2009
Following on from the best practice guidance for national marketing authorisations (MA) pilot initiative announced in June 2007 we have reviewed the current progress and concluded that this fixed
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EMEA: Community herbal monograph on Echinaceae pallidae radix
14.08.2009
Finalised Community herbal monograph on Echinaceae pallidae radix Echinacea pallida Nutt., radix (pale coneflower root): HMPC opinion, herbal monograph, assessment report, list of references ...
EMEA: Community herbal monograph on Ribis nigri folium
14.08.2009
Community herbal monograph on Ribis nigri folium Ribes nigrum L., folium (blackcurrant leaf): draft herbal monograph, draft list of references ...
FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions. Annex 9: Tablet Friability General Chapter
14.08.2009
This annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...
FDA: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions. Annex 10: Polyacrylamide Gel Electrophoresis General Chapter
14.08.2009
This annex is the result of the Q4B process for the Polyacrylamide Gel Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). ...
Polish Ministry of Health: Regulation project concerning the changes in The Decree of Ministry of Health relating to the payment for Marketing Authorization of the veterinary medicinal products
10.08.2009
The regulation project introduce the updated basic amount (from 1126 PLN to 1276 PLN). The payment for MA of the veterinary medicinal products is established in relation to the basic amount. ...
EMEA: Revised Questions and Answers related to PSURS
10.08.2009
Revised Questions and Answers related to Management and assessment of Periodic Safety Update Reports (PSURS) ...