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January 19, 2012
Guidance on the use of non-GLP facilities
Significant changes have been made to the guidance for the use of non-GLP facilities from the MHRA. The document can be found at: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON137893
January 19, 2012
MHRA Consultation – Fees legislation 2012
This consultation seeks views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks. In summary it aims to: reduce DCP fees, where the UK is the RMS by 10% remove differential fee for eCTD simplify the [...]
December 8, 2011
Bio-analytical studies conducted at Cetero Research Houston, Texas (former BA Research)
The US (FDA) has raised some concerns, following its inspection of Cetero Research facilities in Houston (Texas), about the conduct of bio-analytical studies in the period April 2005-June 2010, and has notified pharmaceutical companies that bio-analytical studies conducted by Cetero Research in that period in support of marketing authorisation applications may need to be repeated [...]
December 8, 2011
Fees for type IA variations to be due at start of procedure
The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure. The new rules will apply to all type IA variation notifications for both human and veterinary medicines. The Agency will charge the fee at the start [...]
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