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EC Pharmaceuticals
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Latest news on Pharmaceuticals from the European Commission - Enterprise and Industry Directorate General - Pharmaceuticals regulatory framework and marketing authorisations unit.
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Implementation of the Advanced Therapies Regulation: public consultation on the Revised Clinical Trial Application Form as regards advanced therapy investigational medicinal products
Annex 1 to the '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' defines the standard template for the Clinical Trial Application (CTA) form. It is necessary to amend this form in order to incorporate the changes entailed by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. This public consultation document includes the draft amendments. The public consultation paper is available. Changes compared to the current version of the CTA form are highlighted. Comments on this document should be e-mailed before 15 October 2008 to entr-pharmaceuticals@ec.europa.eu.
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Public consultation on the data fields contained in the 'EudraCT' clinical trials database to be included in the 'EudraPharm' database on medicinal products and made public
On 3 July 2008, the Commission published a guideline on the data fields contained in the clinical trials database (EudraCT) provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products (EudraPharm) provided for in Article 57 of Regulation (EC) No 726/2004. In this guideline, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results to be included in the EudraPharma database and made publicly available. DG ENTR now launches a public consultation on this draft list, which is available. Comments should be e-mailed by 15 October 2008 to entr-pharmaceuticals@ec.europa.eu.
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Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on amendments to Annex I to Directive 2001/83/EC
From 8 May to 10 June 2008, a public consultation was conducted on draft amendments to Annex I to Directive 2001/83/EC as regards advanced therapy medicinal products. The summary outcome of the public consultation paper and detailed contributions to the public consultation are now available
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Implementation of the Advanced Therapies Regulation: Outcome of the Public Consultation on the Certification Of Quality & Non-Clinical Data For Small And Medium-Sized Enterprises
From 5 May to 4 July 2008, a public consultation was conducted on provisions for certification of quality and non-clinical data for small and medium-sized enterprises (SMEs), pursuant to Article 18 of Regulation (EC) No 1394/2007. The summary outcome of the public consultation paper and detailed contributions to the public consultation are now available
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Publication of the guideline on the data fields contained in the clinical trials database
Publication of the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004
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Implementation of the Advanced Therapies Regulation: public consultation on good clinical practice specific to advanced therapy medicinal products
Regulation (EC) No 1394/2007 on advanced therapy medicinal products will apply from 30 December 2008. Article 4 of the Regulation requires that detailed guidelines on good clinical practice (GCP) specific to advanced therapy medicinal products be drawn up. This public consultation document presents preliminary proposals to draft such guidance
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Public consultation on the data fields of the clinical trials database (EudraCT) and the information on trial results for paediatric clinical trials to be made publicly available
Public consultation on the data fields of the clinical trials database (EudraCT) and the information on trial results for paediatric clinical trials to be made publicly available. In February-April 2008, a public consultation was conducted on a draft Guidance on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with article 41 of Regulation No. (EC) 1901/2006 In this draft guidance, it was outlined that the Directorate-General for Enterprise and Industry (DG ENTR) should draw up the list of EudraCT data fields and the information on trial results for paediatric clinical trials to be made publicly available.
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revised Annexes 1, 2 and 3 to the 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
In February-April 2008, a public consultation was conducted on a revision of Annexes 1, 2 and 3 on the Clinical Trial Application Form, the Substantial Amendment Form and the Declaration of the end of a Clinical Trial Form to the ' 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 revision was necessary to take into consideration needs stemming from Regulation (EC) No 1901/2006 on medicinal products for paediatric use, from the Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products (Doc. Ref.EMEA/CHMP/SWP/28367/07, of 19 July 2007) and to clarify the submission of information on the results of clinical trials in view of its publication.
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Update MRL Regulation
Commission Regulation (EC) No 542/2008 of 16 June 2008 amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin, as regards cyfluthrin and lectin extracted from red kidney beans (Phaseolus vulgaris) (Official Journal L 157, 17/6/2008 p.43)
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Summary of responses to the public consultation document on a legislative prooposal to combat counterfeit medicines for human use
Summary of responses to the public consultation document on a legislative prooposal to combat counterfeit medicines for human use is now available
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