This guideline addresses the influence of pharmacogenetics on drug pharmacokinetics, encompassing considerations and requirements for the design and conduct of investigations during drug development. For those cases where pharmacogenetics is envisioned to play a major role in the benefit-risk of a medicinal product because of its impact on pharmacokinetics, guidance is given regarding studies required and recommended at different phases of drug development to ensure satisfactory efficacy and safety in genetic subpopulations that have variable systemic exposure of active substances.
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The general scope of this workshop is to share the experiences gained at the Paediatric Committee and the present approach in reviewing the appropriateness of paediatric formulations as part of paediatric investigation plans (PIPs). Registration closed.
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The general scope of this workshop was to share the experiences gained at the PDCO and the present approach in reviewing the appropriateness of paediatric formulations as part of the paediatric investigation plans (PIP).
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This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings.
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This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of an advanced-therapy medicinal product and the establishment of a specific profile for each risk. With the use of the identified risk profile the applicant shall justify the extent of data presented in the various sections of the marketing-authorisation application dossier.
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This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of an advanced-therapy medicinal product and the establishment of a specific profile for each risk. With the use of the identified risk profile the applicant shall justify the extent of data presented in the various sections of the marketing-authorisation application dossier.
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This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of an ATMP and the establishment of a specific profile for each risk. With the use of the identified risk profile the applicant shall justify the extent of data presented in the various sections of the MAA dossier.
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This guideline describes the intention of the risk-based approach and details its methodological application. The methodology is based on the identification of risks and associated risk factors of an ATMP and the establishment of a specific profile for each risk. With the use of the identified risk profile the applicant shall justify the extent of data presented in the various sections of the MAA dossier.
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Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is needed on the evaluation of genomic influences during pharmacovigilance activities in order to inform and improve clinical use of specific treatments. It is considered necessary to produce a guideline on the evaluation of pharmacogenomic specific issues in the conduct of pharmacovigilance.
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Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is needed on the evaluation of genomic influences during pharmacovigilance activities in order to inform and improve clinical use of specific treatments. It is considered necessary to produce a guideline on the evaluation of pharmacogenomic specific issues in the conduct of pharmacovigilance.
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This guideline gives advice on when to establish a pharmacological ADI and provides guidance on the pharmacological studies and endpoints to be addressed.
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This guideline gives advice on when to establish a pharmacological ADI and provides guidance on the pharmacological studies and endpoints to be addressed.
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This guideline outlines the data requirements to be submitted by the marketing authorisation holder in order to waive the target animal batch safety test for the release of a batch of this product onto the market.
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This revised note is intended to provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals.
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The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have put in place a new process to facilitate interaction between ENCePP partners and third parties, including pharmaceutical companies.
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The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved a work programme for 2012-2015 with the aim of strengthening the integration of herbal medicines in the pharmaceutical legislative framework and benefiting the European consumer through safe and effective use of herbal medicinal products.
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This page lists the opinions adopted at the January 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
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The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a new medicine intended for the treatment of Cushing’s disease in patients who cannot have surgery or for whom surgery has not been successful.
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The European Medicines Agency has released a guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta for public consultation.
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The European Medicines Agency has begun a review of the benefits and risks of the multiple-sclerosis medicine Gilenya. This follows concerns over the effects of the medicine on the heart after the first dose.
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During its first meeting in 2012, the Committee for Orphan Medicinal Products (COMP) adopted a total of 16 recommendations for orphan designation, including for a number of substances intended for the treatment of diseases for which no orphan designation has ever been granted, and a substance intended for the treatment of a neglected tropical disease.
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The Committee adopted by consensus a positive opinion for an initial marketing authorisation application under exceptional circumstances for Zulvac 1+8 Bovis, from Pfizer Limited, a vaccine for the active immunisation of cattle to prevent viraemia caused by Bluetongue Virus, serotypes 1 and 8.
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The European Medicines Agency has launched a public consultation on the revised guideline on the evaluation of human anticancer medicines.
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The European Medicines Agency is reviewing aliskiren-containing medicines, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication.
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This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2).
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This guideline replaces guideline CPMP/QWP/227/02 Rev 2 (EMEA/CVMP/134/02 Rev.2).
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