Tag Archive
The following is a list of all entries tagged with CTD:
Drug Regulator, MHRA, Publishes an Updated Guide for Manufactures on Clinical Investigations to be Carried out in the UK
Filed in clinical, regulatory, January 6, 2010, 8:26 amThe Medical Devices Regulations 2002 (SI No 618), as amended by the Medical Devices (Amendment) Regulations 2008, came into force on 13 June 2002 and implement the provisions of the Medical Devices Directive 93/42/EEC (as amended by Directive 2007/47/EC), the Active Implantable Medical Devices Directive 90/385/EEC (as amended by Directive 2007/47/EC) and the In Vitro Diagnostic Medical Devices Directive 98/79/EEC. These Regulations establish systems under which a manufacturer must submit to the UK Competent Authority, information about clinical investigations of medical devices to be carried out in the UK.
Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A
Filed in business, licensing, regulatory, December 26, 2009, 11:04 amThis question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification. The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.
Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2)
Filed in manufacturing, regulatory, December 25, 2009, 8:26 amThe Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
European Commission Publishes Assessment of the Functioning of the Clinical Trials Directive
Filed in clinical, report, November 22, 2009, 12:35 pmThis assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.
Clinical Trials Regulations, EU Commission, Clinical Trials Draft Regulations
Filed in clinical, regulatory, August 6, 2009, 12:11 pmThe European Commission has published draft guidance for comment on “Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial”
The Impact of the Clinical Trails Directive
Filed in clinical, regulatory, July 6, 2009, 9:01 amThe impact of the clinical trials directice on clinical drug development has been evaluated by ICREL (Impact of Clinical Research of European Legislation) who have just published their report (HEALTH-F1-2007-201002)
FDA guidance – Q8(R1) Pharamceutical Development – submission contents and overall pharmaceutical development guidance.
Filed in clinical, regulatory, June 12, 2009, 4:13 pmThe FDA has produced a revised version of the Q8 pharmaceutical development guidance. I believe this documentation to be of such critical nature is to be recommended reading for anybody working in the area of drug development of discovery.
MHRA publishes guidance on the Medical Devices Directives
Filed in Uncategorized, clinical, devices, regulatory, June 1, 2009, 9:55 amThe MHRA has published Guidance on the EC Medical Devices Directives. The guidance document is a comprehensive document, and covers the regulations in some detail:
FDA Guidance for Industry – Intergrated Summaries of Effectivenss and Safety: Location within the Common Technical Document
Filed in clinical, medical report, regulatory, report, May 4, 2009, 8:20 pmThis new guidance focuses on where to place ISE and ISS documents within the structure of the CTD or eCTD. It does not outline in detail the content for the ISE and ISS. The content will be addressed in separate guidances.
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