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Treatment of Alzheimer's disease and other dementias. The European Medicines Agency have published: Scientific guideline: Draft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias, draft: consultation open. The proposed guideline will replace ‘Guideline on medicinal products for the treatment of Alzheimer’s disease and other dementias’ (CPMP/EWP/553/95 Rev. 1). More information is available on the EMA's website.
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Antimicrobial resistance transfer from companion animals. The European Medicines Agency have published: Scientific guideline: Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals, draft: consultation open. Antimicrobials are important tools for the therapy of infectious bacterial diseases in companion animals. Loss of efficacy of available antimicrobial substances can seriously compromise animal health and welfare. The need for the development of new antimicrobials for the therapy of multi-resistant infections, particularly those caused by Gram-negative bacteria, has been acknowledged in human medicine. For the future a corresponding need in veterinary medicine is to be expected. More information is available on the EMA's website.
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Harmonisation of withdrawal periods. The European Medicines Agency have published: Scientific guideline: Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods, draft: consultation open. The proposed guideline will replace the CVMP Note for guidance: approach towards harmonisation of withdrawal periods (EMA/CVMP/036/95). More information is available on the EMA's website.
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Efficacy studies for intramammary products for use in cattle. The European Medicines Agency have published: Scientific guideline: Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle, draft: consultation open. This guideline replaces the CVMP guideline “Conduct of efficacy studies for intramammary products for use in cattle “(CVMP/344/1999 Rev.1). More information is available on the EMA's website.
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Adverse events to veterinary medicinal products. The European Medicines Agency have published: Scientific guideline: Recommendation on harmonising the approach to causality assessment for adverse events to veterinary medicinal products (Rev.1), adopted. This recommendation provides further guidance on how to carry out causality assessment, based on the principles laid out in Volume 9B of The Rules Governing Medicinal Products in the European Union (EU) – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use and includes additional guidance on causality assessment of adverse events classified as off-label and lack of expected efficacy (LEE) concerning pharmaceuticals. For vaccines guidance on LEE reports and adverse events after mixing of vaccines will be provided in due time. More information is available on the EMA's website.
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Injection site residues. The European Medicines Agency have published: Scientific guideline: Draft reflection paper on injection site residues: considerations for risk assessment and residue surveillance (Rev.1), draft: consultation open. In June 2008 the CVMP published a first version of this reflection paper for consultation. As detailed in the problem statement presented in original reflection paper, residues in injection site muscle for some products tend to be dramatically higher than residues in non-injection site muscle (as well as in fat, liver and kidney). The result is that a single carcass may contain muscles with very different residue levels of injectable substances, and these differing levels of residues in a single tissue type make setting an appropriate MRL very challenging. More information is available on the EMA's website.
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Statistical methodology for design and analysis of dose finding studies. The European Medicines Agency have published: Regulatory and procedural guideline: Draft qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase II dose finding studies under model uncertainty, draft: consultation open. Estimating dose-response and selection of a dose for confirmatory Phase III trials and potential market authorisation is among the most difficult elements of the whole development process. Dose finding studies are commonly designed using a small number of doses and a narrow dose-range, often focused on the upper end of the dose response relationship. More information is available on the EMA's website.
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Public consultation on Commission guideline on paediatric investigation plans. In accordance with the Paediatric Regulation (EC) 1901/2006 the Commission has to draw up detailed arrangements concerning the format and content of paediatric investigation plans. In September 2008 the Commission published a relevant guideline, which has been in use for the last five years. In its recent report on the Paediatric Regulation, the Commission undertook to review the guideline in order to take into account the experience gained. The Commission therefore requested the European Medicines Agency and its Paediatric Committee to suggest amendments to the current guideline. In order to further explore which parts of the current guideline should be updated the Commission has prepared a concept paper which is now being rolled out for public consultation with a view of receiving feedback from stakeholders on this issue. More information is available on the Commission's website.
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Data-driven model in Alzheimer's disease. The European Medicines Agency have published: Regulatory and procedural guideline: Qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease, adopted. Regulatory and procedural guideline: Qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease, adopted. More information is available on the EMA's website.
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Demonstration of therapeutic equivalence for products in the GIT. The European Medicines Agency have published: Scientific guideline: Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract, draft: consultation open. The note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95) [in the following called ‘guideline’] provides general recommendations on the clinical requirements for respective formulations with known active substances. This concept paper discusses the need to expand the guidance on locally applied and locally acting gastrointestinal products. More information is available on the EMA's website.
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Medicinal products for the treatment of HIV infection. The European Medicines Agency have published: Scientific guideline: Draft guideline on the clinical development of medicinal products for the treatment of HIV infection (Rev.3), draft: consultation open. This guideline replaces EMEA/CPMP/EWP/633/02 Rev 2. It provides guidance on the clinical development of direct-acting antiretrovirals for the treatment of HIV infection. More information is available on the EMA's website.
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Paediatric addendum on clinical investigations in treatment of hypertension. The European Medicines Agency have published: Scientific guideline: Draft paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension, draft: consultation open. This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Hypertension (EMA/238/1995/Rev. 3, 18 November 2010). It is not meant as a guidance document on its own but rather highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects. More information is available on the EMA's website.
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ICH S1: Rodent carcinogenicity studies for human pharmaceuticals. The European Medicines Agency have published: Regulatory and procedural guideline: Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals, adopted. A change to the current ICH S1 guidance on rodent carcinogenicity testing is being considered. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which two-year rodent carcinogenicity studies add value to that assessment. More information is available on the EMA's website.
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Implementation of the variations guidelines in the centralised procedure. The European Medicines Agency have published: Regulatory and procedural guideline: Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure. This question and answer (Q&A) document provides practical considerations concerning the implementation of the guidelines of 16.5.2013 on the details of the various categories of variations, on the operation of the procedures laid down in chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 and on the documentation to be submitted pursuant to those procedures (hereafter called ‘variations guidelines’). The Q&A applies to all medicinal products for human use that apply for a variation or submit post-authorisation measure (PAM) data as of the 4th of August 2013. More information is available on the EMA's website.
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ICH E2B (R3): Electronic transmission of individual case safety reports (ICSRs). The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide Step 5, adopted. More information is available on the EMA's website.
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Risk management plan for generics. The European Medicines Agency have published: Regulatory and procedural guideline: Guidance on format of the risk-management plan in the European Union for generics. More information is available on the EMA's website.
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Risk management plan in the EU. The European Medicines Agency have published: Regulatory and procedural guideline: Guidance on format of the risk-management plan in the European Union – in integrated format. More information is available on the EMA's website.
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Triggers for inspections of bioequivalence trials. The European Medicines Agency have published: Regulatory and procedural guideline: Guidance on triggers for inspections of bioequivalence trials, adopted. More information is available on the EMA's website.
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ICH M8: Electronic common technical document (eCTD). The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M8 on eCTD – questions and answers, adopted. In November 2010, the ICH steering committee endorsed the establishment of an Expert Working Group (EWG)/Implementation Working Group (IWG) for the eCTD and assigned the topic code "M8". Work in relation to the eCTD had previously been undertaken by the M2 EWG. More information is available on the EMA's website.
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Parenteral administration of coated nanomedicine products. The European Medicines Agency have published: Scientific guideline: Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products, adopted. This paper highlights issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration. More information is available on the EMA's website.
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Paediatric therapeutic needs: nephro-urology. The European Medicines Agency have published: Draft inventory of paediatric therapeutic needs - Nephro-urology. Based on Article 43 of the European Union Paediatric Regulation, the Paediatric Committee (PDCO) at the European Medicines Agency is working to establish an inventory to identify the needs in the different therapeutic areas where there should be research and development of medicinal products for children. The inventory is based on the results of a survey of all paediatric uses of medicines in Europe and on the existing list of paediatric needs established by the former Paediatric Working Party. This list covers nephro-urology. More information is available on the EMA's website.
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ICH Q3D: Impurities: Guideline for elemental impurities. The European Medicines Agency have published: Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3D on elemental impurities - Step 3, draft. This new guidance is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities. An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents. The proposed new Guideline Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification. More information is available on the EMA's website and on the ICH's website.
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