September 1, 2010
A new table summarizing the additional Data requested for New Application in the MRP/DCP which are not stated in the current EU legislation and /or volume 2B is available on the CMDh website. To view the table, please click on the link below: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/CMDh_043_2007_Rev5_August10.pdf
August 18, 2010
New CTA regulations are applicable to all submissions, including amendments, in Poland. Submissions can no longer be done by a CRO but by a physical person, who can however be an employee of the CRO. Also two letters of authorisation are required, one from the sponsor authorising the legal representative and the second from the [...]
August 19, 2010
A new template for cover letter for new Marketing Authorisation application is available in the HMA website. http://www.hma.eu/uploads/media/Cover_letter_for_new_MA_application_Final-_EXT-579873-2008.doc
August 18, 2010
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have developed a pilot programme of joined GMP inspections for manufacturers of medicinal products. This scheme applies both to Companies submitting in parallel two equivalent new marketing authorization applications for the same drug to both agencies and to Companies hosting one single [...]
August 19, 2010
From Friday 8th October 2010 and over four weekends, the MHRA will be moving to its new location at 151 Buckingham Palace Road, Victoria, London, SW1W 9SZ. MHRA will ensure minimal disruption to services during the move.
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