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		<title>Additional Data Requested for New Application in the MRP / DCP (01-SEP-10)</title>
		<description><![CDATA[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]]></description>
		<link>http://www.cambreg.co.uk/news/?p=419</link>
			</item>
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		<title>New CTA regulations in Poland (18-AUG-10).</title>
		<description><![CDATA[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 [...]]]></description>
		<link>http://www.cambreg.co.uk/news/?p=407</link>
			</item>
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		<title>Submission of Application Dossier &#8211; new Cover Letter Template (18-AUG-10).</title>
		<description><![CDATA[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]]></description>
		<link>http://www.cambreg.co.uk/news/?p=403</link>
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		<title>Join GMP inpection pilot scheme in US and EU (18-AUG-10).</title>
		<description><![CDATA[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 [...]]]></description>
		<link>http://www.cambreg.co.uk/news/?p=398</link>
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		<title>Relocation, relocation (18-AUG-10)</title>
		<description><![CDATA[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.]]></description>
		<link>http://www.cambreg.co.uk/news/?p=394</link>
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		<title>Plasma- and urine-derived medicinal products and Creutzfeldt-Jakob disease (09-AUG-10)</title>
		<description><![CDATA[The Committee for Medicinal Products for Human use (CHMP) has issued a draft statement for consultation on the use plasma- and urine-derived medicinal products and Creutzfeldt-Jakob disease. The CHMP points out the importance to investigate the capacities of the manufacturing process for plasma-derived products as the available data support the reduction of infectivity by steps [...]]]></description>
		<link>http://www.cambreg.co.uk/news/?p=389</link>
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		<title>Advanced Therapy Medicinal Products and Creutzfeldt-Jakob disease (09-AUG-10)</title>
		<description><![CDATA[The Committee for Medicinal Products for Human use (CHMP) has issued a statement on the use of Advanced Therapy Medicinal Products (ATMP) and Creutzfeldt-Jakob disease. ATMPs are subject to three types of considerations. For cell based products from autologous donors no specific considerations are required. For cell based products from allogeneic donors, the WHO guidelines [...]]]></description>
		<link>http://www.cambreg.co.uk/news/?p=386</link>
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		<title>New EMA bioequivalence guideline (09-AUG-10)</title>
		<description><![CDATA[The guideline on the investigation of bioequivalence from the Committee for Medicinal Products for Human use (CHMP) came into effect on the 1st August 2010. This guidance contains detailed descriptions on how pharmacokinetic-based bioequivalence studies should be conducted and evaluated as well as recommendations for biowaivers.]]></description>
		<link>http://www.cambreg.co.uk/news/?p=382</link>
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		<title>NICE approves over 80% of treatments (28-JUL-10)</title>
		<description><![CDATA[Since it started in 1999, NICE&#8217;s technology appraisals have reached over 80% approval of drugs (including recommended and optimised) and 6% of treatments have been approved for research only.  The recommendations are based on the effectiveness of the treatment compared with competitors treatments already available on the NHS.]]></description>
		<link>http://www.cambreg.co.uk/news/?p=377</link>
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		<title>Labelling of Medicines &#8211; October 2010 deadline (28-JUL-10)</title>
		<description><![CDATA[Marketing authorisation holders for medicines for which the marketing authorisation  was  granted before 30 October 2005 had a 5 years transitional period to amend the labelling to comply with Articles 54(a), 54(e) and 56(a). The MHRA has reminded MAHs to submit their applications by the 1 August 2010 to ensure compliance  by 30 October 2010. The [...]]]></description>
		<link>http://www.cambreg.co.uk/news/?p=367</link>
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