DIA Global Regulatory Activity Digest - Drug Information Association

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This Guideline lays down the non-clinical and clinical requirements for a biological medicinal product claiming to be similar to another one already marketed. The non-clinical section addresses the pharmaco-toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic, efficacy studies. The section on clinical safety and pharmacovigilance addresses clinical safety studies as well as the risk management This guideline addresses the general principles for the non-clinical and clinical development and assessment of the marketing authorisation applications of similar biological medicinal products containing recombinant proteins as active substance(s). This guideline does not address the comparability exercise for changes introduced in the manufacturing process of a given product (i.e. changes during development and post-authorisation). EUROPEAN UNION - CHMP Guideline EMEA/CHMP/BMWP/94528/2005: Similar Biological Medicinal Products Containing Somatropin/ Annex to Guid. on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues, 16- May-2005 Current version. Date for coming into effect: 01-Jun-2006. This final version replaces the draft version of May-2005 (50680). This document is an annex to the draft guideline on similar biological products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (56482). This guideline lays down the general requirements for demonstration of comparability of two recombinant human somatropin-containing medicinal products. EUROPEAN UNION - CHMP Guideline EMEA/CHMP/BWP/49348/2005: Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality issues, 22-Feb-2006 Current version. Date for coming into effect: 01-Jun-2006. This final version replaces the draft version of Mar-2005 (49338). This guideline addresses quality issues during demonstration of comparability for Similar Biological Medicinal Products (biosimilar products) containing recombinant DNA-derived proteins. As a consequence, the principles adopted and explained in this document should apply to proteins and peptides, their derivatives and products of which they are components (e.g. conjugates). For other situations see Guideline on Similar Biological Medicinal Products, CHMP/437/04. (53865). EUROPEAN UNION - CMD(h) Press Release: Report from the Meeting held on 20/21-Feb-2006 General Issues: - CMD(h) Rules of Procedure - Role of the Vice-Chairperson of the CMD(h)
- Functions and Tasks for the CMD(h) - Procedure for adoption of lists of questions for Applications referred to the CMD(h) in accordance with Article 29(1) of Directive 2001/83/EC, as amended - CMD(h) Position on changing the Reference Member State - E-mail addresses for submission of translations in Mutual Recognition and Decentralised procedures - E-mail addresses for submission of electronic responses to the List of Questions for Applications referred to the CMD(h) in accordance with Article 29(1) of Directive 2001/83/EC, as amended - <strong>Information</strong> on applications referred to the CMD(h) in accordance with Article 29(1) of Directive 2001/83/EC, as amended The next CMD(h) meeting will be held on 20/21/22-Mar-2006. EUROPEAN UNION - CMD(h): Contact E-Mail Addresses for Submission of Electronic Version of the Responses to the List of Questions for Applications Referred to the CMD(h), Feb-2006 The list is provided to assist pharmaceutical companies identifying an email address for submission of electronic version of the response to the list of questions in each Member State. EUROPEAN UNION - CMD(h): Functions and Tasks, Feb-2006 This document describes the CMD(h)'s functions and tasks. EUROPEAN UNION - CMD(h): Position on changing the Reference Member State, Revision 2, Mar-2006 The CMD(h) agreed on a position to facilitate the process for a MAH, if a request for a change of the original Reference Member State should arise. EUROPEAN UNION - CMD(h): Rules of Procedure, Feb-2006 This document defines the CMD(h) 's Rules of Procedure. EUROPEAN UNION - EMEA Press Release EMEA/84561/2006: European Medicines Agency Finalises Set of Guidelines on Similar Biological Medicines and Publishes Two more New Concept Papers, 08-Mar-2006 The European Medicines Agency published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation. EUROPEAN UNION - Heads of Medicines Agencies (HMA) - Homeopathic Medicinal Products Working Group (HMPWG): Draft Guidance on Module 3 of the Homeopathic Medicinal Products Dossier, Mar-2006 Current version of the Guidance on Module 3 of the Homeopathic Medicinal Products
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DIA Global Regulatory Activity Digest - Drug Information Association

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