Pharmaceuticals Archives - 2010

  • 9/12/2010
    ICH guideline E2F - Note for guidance on development safety update reportspdf
    The ICH guideline E2F gives sponsors guidance as to how to draw up the yearly safety report (Article 17(2) of the 'Clinical Trials Directive' 2001/20/EC).
    To give additional support, ICH has established 'model DSURs' which are accessible here . These 'model DSURs' take account of the differing knowledge about a medicine, depending on whether the sponsor holds the marketing authorisation or not.

   

  • 9/11/2010
    EudraCT - list of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee)
    In accordance with point 3.3. of Commission Guidance 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT), where a negative opinion on a clinical trial bas been issued by an Ethics Committee, the information on the trial will be published, together with a field indicating the reason for the negative opinion.
    This document lists the fields which are going to be contained in EudraCT. This list is an addendum to the technical guidance on EudraCT contained in EudraLex Volume 10. The document is here .
  • 9/11/2010
    Public consultation on "draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)".
    The responses are published here . One submitting party (Actavis) requested not to publish its submission.
  • 30/09/2010
    Guidance documents applying to clinical trials - Questions & Answers Document, Version 7.0 (September 2010)
    The Questions and Answers document in the EudraLex chapter on clinical trials has been revised.

    The version 7.0 of this document is available here .
  • 22/09/2010
    Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions.
    The responses are published here .
  • 03/09/2010
    Important change to the planned production of EudraCT Version 8.0 and the Clinical Trials Application Form
    The production of EudraCT Version 8.0 has been delayed. Consequently, Revision 4 dated November 2009 of the Clinical Trials Application Form will not apply for the time being. For more information please refer to the EudraCT website .

  • 20/07/2010
    Note to Clinical Trials Application Form.EudraCT Version 8.0 will go into production on 7 September 2010. EudraCT Version 8.0 will use the Clinical Trials Application Form (Annex 1 Revision 4 dated November 2009).
    Consequently, the Clinical Trials Application Form (Annex 1 Revision 4 dated November 2009) will apply as of 7 September 2010.More information is available here .

 

  • 22/06/2010
    Commission is looking for health professionals and patient representatives for the Paediatric Committee
    The Paediatric Regulation (Regulation (EC) No 1901/2006) establishes a scientific committee, the Paediatric Committee, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. This committee shall include representatives of the civil society, which represent patient associations and health professionals.
    Those members are appointed by the Commission for a renewable period of three years on the basis of a public call for expression of interest.
    Today the Commission publishes such call and invites health professionals and patient associations to put forward candidatures, until 6 September 2010 at the latest, for a new mandate starting in 2011. Details concerning the requested candidate profiles, the work of committee members, the application and selection procedure can be found in the following Public call for expression of interest (PDCO/10/PH/1) : Here pdf(39 KB)
    Update 10/09/2010: The Commission decided to prolong the deadline for submitting applications until 6 October 2010. Furthermore it is clarified that the proposed member and the proposed alternate do not have to represent necessarily the same association. Different association may decide to suggest together a pair of candidates.
  • 17/06/2010
    Public consultation document – draft revised version of detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)

  • 2/06/2010
    Report on rewards and incentives under the Paediatric Regulation
    The Paediatric Regulation (Regulation (EC) No 1901/2006) provides incentives and rewards to companies that have undertaken research into, and the development and authorisation of pharmaceuticals for children. The Commission is obligated to report on companies and products that have benefited from those rewards and incentives as well as on companies that have failed to comply with any of the obligations in the Regulation (Article 50(1) of the Regulation). In this regard the European Medicines Agency has compiled a report, which covers the first three years of the Paediatric Regulation from its entry into force to 2009.
    The report is available here pdf.

  • 01/06/2010
    Public consultation document: Draft Implementing technical guidance - List of fields for result-related information to be submitted to the 'EudraCT' clinical trials database, and to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41 of Regulation (EC) No 1901/2006 and their implementing guidelines 2008/C168/02 and 2009/C28/01
    At present, no result-related data is uploaded in EudraCT. This draft document sets out the details as to how result-related information should be uploaded in EudraCT in the future
    This draft document is herewith submitted for public consultation. It is available here: Guidancepdf(36 KB) - Annexpdf(165 KB) .
    Apart from this initiative, please note that the information contained in EudraCT (ie protocol-related information) is going to be made publicly accessible, in accordance with the applicable guidelines, in September 2010.

    Public consultation on draft guidance - Harmonised requirements for non-investigational medicinal products in CTA submissions
    This draft guidance aims at clarifying the dossier-requirements for so-called non-investigational medicinal products. It is herewith submitted for public consultation. The consultation document is accessible herepdf(43 KB) .
  • 11/05/2010
    List of herbals use in traditional herbal medicines:
    Commission decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 25 March 2010 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 26 March 2010. This decision includes ‘Mentha x piperita L.’ in the list of herbal substances.
    The text of the decision is available here.

    pdf
    Commission decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 19 January 2010. This decision includes ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ in the list of herbal substances.
    The text of the decision is available here

    pdf

    Commission decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products Commission Decision of 28 July 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products was published in the Official Journal on 16 January 2010. This decision includes ‘Calendula officinalis (L.)’ and ‘Pimpinella anisum (L.)’ in the list of herbal substances.
    The text of the decision is available here.pdf
  • 13/04/2010
    Public consultation on the legal framework for veterinary medicinal products: Better regulation of veterinary pharmaceuticals: how to put in place a simpler legal framework, safeguarding public and animal health while increasing the competitiveness of companies
    Today a public consultation was launched on the legal framework for veterinary medicinal products. By means of this public consultation DG SANCO intends to consult all stakeholders. An on-line tool has been designed to register your comments and can be found here. A summary of the outcome of the consultation will be published and your input will be utilised for the impact assessment report on a revision of the legal framework for veterinary medicinal products.

    Closing date: 15 July 2010

    More information: On-line form
    Contact: martinus.nagtzaam@ec.europa.eu

  • 12/04/2010
    Final report on Evaluation of the European Medicines Agency
    pdf(2 MB)
    An evaluation of the European Medicines Agency has been required by Regulation (EC) No 726/2004*, the Implementing Measures of the Financial Regulation and by the European Parliament.

    The evaluation of the European Medicines Agency was conducted by Ernst & Young between January and December 2009 and a report was finalised subsequently.

    On the basis of the assessment of the effectiveness and efficiency of the system, the evaluation addresses the contribution of the Agency to the protection of public and animal health, its contribution to the achievement of an operating internal market and the added value of the whole system for the stakeholders.

    The evaluation report is hereby made public.

    * Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

  • 07/04/2010
    Handling of duplicate marketing authorisation applications under Article 82(1) of Regulation (EC) No 726/2004

    pdf(34 KB)
    The requests for duplicate marketing authorisations under Article 82(1) of Regulation 726/2004 have increased steadily and it is important to apply clear criteria in a coherent manner drawing on the experience gathered until now in the processing of requests under Article 82.
    A note summarising the relevant principles and procedures that are applied when dealing with requests for authorisations to submit a duplicate marketing authorisation application has been recently submitted to the Agency.

    With a view to create more transparency and predictability for the stakeholders concerned, that note is made publicly available here.

  • 31/03/2010
    EudraLex on CD Version 22 - April 2010
    Now, you can create your own CD with the whole Pharmaceutical Legislation (Human and Veterinary) and an integrated search engine.The CD-Rom is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection.
    For a non-commercial use, the CD-Rom may be duplicated and the documents may be printed.

  • 30/03/2010
    Summary of the Responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"
    pdf(61 KB)
    This document summarises the responses to the public consultation paper "Assessment of the functioning of the 'Clinical Trials Directive' 2001/20/EC"
    Revision of 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 (Version of March 2010).
    This Document is available in Volume 10 of EudraLex.
    Guidance documents applying to clinical trials - Questions & Answers Document, Version 5.0 (March 2010)
    The Questions and Answers document in the EudraLex chapter on clinical trials has been revised.
    The version 5.0 of this document is available in Volume 10 of EudraLex.

  • 08/03/2010
    Public Consultation : Notice to Applicants – Veterinary Medicinal Products - Volume 6B
    DG Health and Consumers has launched a public consultation on the veterinary Notice to Applicants Volume 6B – Presentation and content of the dossier. The document, in particular the formats, have been updated in accordance with the new Annex I as published in Directive 2009/9/EC. Additionally, certain terms as well as legal references have been adapted. The application form from the beginning of the document has been removed being a stand-alone form since many years. Closing Date: 15 May 2010
    Downloads
    Presentation and content of the dossier
    rtf(3 MB)
    Presentation and content of the dossierpdf(428 KB)
  • 18/01/2010
    Updating the Notice to Applicants – Veterinary Medicinal Products - Volume 6A Chapter 7 “General Information” DG Enterprise and Industry releases an updated version of Chapter 7 “General Information” of the veterinary Notice to Applicants Volume 6A. The revised version provides updates required by Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, The Netherlands, Portugal, Slovakia, Sweden and the United Kingdom.
    Eudralex Volume 6 >>>

  • 22/12/2009
    Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products.
    The Commission “Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products” Following Article 4(1)(a) of Commission Regulation (EC) No 1234/2008 of 24 of November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products was adopted by the Commission on 21 December 2009 and shall be published in the Official Journal before the end of the year. The guideline applies from 1 January 2010.