Tag Archive
The following is a list of all entries tagged with EMEA:
Drug Regulators, EMEA, Publish Draft Guidance on Validation of Bioanalytical Methods
Filed in clinical, December 31, 2009, 10:32 amMeasurement of drug concentrations in biological matrices is an important aspect of medicinal product development for those products containing new active substances as well as for line extensions and generic products.
Drug Regulator, EMEA, Publishes New Visual Identity, web/email addresses and organisation chart for the European Medicines Agency
Filed in EMEA, December 24, 2009, 9:23 amOn 8 December 2009, The EMEA will officially launch our new visual identity, comprising a new logo, new colour chart, new typography and rebranded materials based on these elements.
EMEA Publishes Comments Received on Development of Guidance for Products for Treating Smoking
Filed in EMEA, medical report, December 13, 2009, 8:54 amInterested party (Organisations or individuals) that commented on the draft Guideline as released for consultation
EMEA – SME Scheme Reminder
Filed in EMEA, business, December 10, 2009, 8:23 amPursuant to the SME regulation, companies can access financial assistance (in the form of fee reductions and fee deferrals) and administrative assistance from the agency, details of which are outlined in Section 2 of this guide. To facilitate contact with the agency, an ‘SME Office’ was launched in December 2005 and is dedicated to addressing the particular needs of smaller companies.
European Commission 2006 Guidance Reminder – Conditional Approval
Filed in regulatory, December 1, 2009, 10:54 amIn the case of certain categories of medicinal products,however, in order to meet unmet medical needs of patients and in the interests of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally the case and subject to specific obligations, hereinafter ‘conditional marketing authorisations’
Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis
Filed in clinical, regulatory, November 30, 2009, 10:54 amCF is a life threatening and chronically debilitating disease, impairing the Quality of life, characterised by progressive bronchiectasis and obstructive pulmonary disease (> 90% patients).
Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses
Filed in EMEA, biotechnology, regulatory, November 21, 2009, 12:29 pmOncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations.
Drug Regulators Publish Concept Paper on the Need to Revise Clinical Guidance for Depression
Filed in EMEA, clinical, regulatory, November 11, 2009, 3:48 pmMajor Depressive Disorder (MDD) is one of the most common psychiatric disorders, which is the fourth leading cause of global disease burden and affects about 15 % of the general population. As outlined in the guidance document MDD is not a benign disorder and risk of suicide is considerable.
Drug Regulators Publish Draft Guidance on Biosimilars for Recombinant Erthropoietins
Filed in Uncategorized, October 27, 2009, 10:59 amThis guideline lays down the non-clinical and clinical requirements for erythropoietin containing medicinal products claiming to be similar to another one already marketed.
Parallel Scientific Advice at the Regualtors
Filed in EMEA, regulatory, October 19, 2009, 3:01 pmJust a reminder that the FDA CBER (centre for biological evaluation and research) and EMEA have a combined scientific advice procedure. It is a pilot programme at the moment and is developed to offer a parallel process to industry.
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