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The European Medicines Agency has launched a public consultation on the changes to the product information stemming from the new pharmacovigilance legislation. The legislation requires the addition of information to the summary of product characteristics, which is targeted at healthcare professionals, and to the package leaflet, which is targeted at patients and consumers. This information includes: a statement and a black symbol for medicines that are under additional monitoring for safety issues;a statement encouraging healthcare professionals and patients to report suspected side effects from the medicine to their national reporting system. The changes will apply to all centrally authorised human medicines, as well as human medicines authorised through the mutual-recognition or decentralised procedures.
The consultation is opened until 17 august 2012.
The Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines. Its recommendations are considered by the Committee for Medicinal Products for Human Use (CHMP) when it adopts opinions for centrally authorised medicines and referral procedures and by the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) when it provides a recommendation on the use of a medecine in a Member State.
The members and alternates of the PRAC are nominated by the European Union Member States, in consultation with the Agency's Management Board. They are chosen on the strength of their qualifications and expertise with regard to pharmacovigilance matters and risk assessments of medicines for human use.
To represent healthcare professionals and patient organisations, the European Commission appoints two members and two alternates following consultation with the European Parliament. The European Commission also appoints six independent scientific experts.
All serve on the Committee for a period of three years which is renewable once.
The PRAC is composed of: - a chair and a vice chair, elected by serving PRAC members; - one member and an alternate nominated by each of the 27 Member States; - one member and an alternate nominated by Iceland and by Norway; - six independent scientific experts nominated by the European Commission; - one member and an alternate nominated by the European Commission after consultation of the European Parliament to represent healthcare professionals; - one member and one alternate nominated by the European Commission after consultation of the European Parliament to represent patients organisations;
The European Medicines Agency has finalised the revision of its guideline on the processing of renewals in the centralised procedure.
This guideline has been revised in order to reflect the provisions of the new pharmacovigilance legislation, which begins to apply on 2 of july 2012.
The Agency has finalised this guidance document after considering the comments received during the public consultation period in March and April 2012. The final version was adopted by the Agency's Committee for Medicinal Products for Human Use (CHMP) in June 2012.
This guideline applies to all renewal applications submitted as of today, 2 July 2012.
The European Medicines Agency has released two further modules of the guideline on good pharmacovigilance practices (GVP) for public consultation until 24 August 2012. The modules are: - Module III: Pharmacovigilance inspections - Module X: Additional monitoring.
The two modules released today are the first in the second batch of modules to be released for public consultation. The remaining seven draft modules making up the entire GVP package are under development and will be released for consultation later in the year.
The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today. The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are: Module I: Pharmacovigilance systems and their quality systems;
Module II: Pharmacovigilance systems master files;
Module V: Risk management systems;
Module VI: Management and reporting of adverse reactions to medicinal products;
Module VII: Periodic safety update reports;
Module VIII: Post-authorisation safety studies;
Module IX: Signal management.
On Wednesday 27 June 2012, the Agency will be publishing two further GVP modules for public consultation. These will be: Module III: Pharmacovigilance inspections;
Module X: Additional monitoring.
The finalised GVP modules on post-authorisation safety studies and risk management plans refer to the guide on methodological standards in pharmacoepidemiology, which is available on the website of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Public Consultation Paper on the review of the 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.
Commission Regulation (EC) No 1234/2008 establishes in its Article 4(2) that the guidelines on the details of the various categories of variations shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 of this Regulation.
With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on a contribution to the review of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMA and it will form the basis for the review of the Commission variations guidelines.
The European Medicines Agency has launched its website on suspected side-effect reports for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.
The report shows continuously high levels of activities in almost all of the Agency’s business areas. There was a slight increase in the number of applications for initial marketing authorisations for medicines for human use, from 91 applications in 2010 to 100 applications in 2011. Most of this increase was due to applications received for new medicines: this number rose by over 40% from 34 in 2010 to 48 in 2011
The European Medicines Agency has today begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu.
The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency’s continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.
The information published today relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing authorisation holders. These aggregated data can be viewed by age group, sex, type of suspected side effect and by outcome. Within a year the Agency aims to additionally publish suspected side effect reports for common drug substances used in nationally authorised medicines.
Side-effect reporting is a key element in ensuring the detection of new or changing safety issues, and the Agency continues to further strengthen its work with partners and stakeholders across Europe to ensure a robust system for safety signal detection. In June, the Agency will launch the website in the remaining 22 official EU languages.
L’initiative. Depuis 2007, près de 1 600 fiches de pharmacovigilance ont été transmises par les pharmaciens Giphar, équipés d’un logiciel ad hoc. Une participation active à la surveillance des...
International Clinical Trials Day aims to enhance communication and coordination of clinical trials between countries, resulting in better clinical research that is relevant to the needs of patients everywhere. It is celebrated every year on or around 20 May, commemorating the day that James Lindstarted his famous trial comparing treatments for scurvy on 20 May 1747.
Publics concernés : membres des cabinets des ministres chargés de la santé et de la sécurité sociale, membres des commissions et conseils siégeant auprès de ces ministres, agents des administrations centrales de la santé et de la sécurité sociale, des agences régionales de santé, de l'Office national d'indemnisation des accidents médicaux, de l'Etablissement français du sang, de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, de l'Institut national de veille sanitaire, de l'Institut national du cancer, de l'Institut national de prévention et d'éducation par la santé, de l'Agence de biomédecine, de l'Agence nationale de sécurité du médicament, de la Haute Autorité de santé, de l'Institut de radioprotection et de sûreté nucléaire et de l'Autorité de sûreté nucléaire, membres de leurs instances collégiales délibérantes ou consultatives et les experts internes ou externes ainsi que les membres des comités de protection des personnes et des commissions de conciliation et d'indemnisation.
Objet : unifier et étendre le champ de la déclaration publique d'intérêts ; assurer la transparence des débats des instances collégiales consultatives.
Entrée en vigueur : le 1er juillet 2012.
Notice : le décret prévoit que chaque personne concernée établit, lors de sa prise de fonctions ou au début de sa collaboration, une déclaration d'intérêts faisant apparaître les liens directs ou par personne interposée qu'elle a ou a eu durant les cinq années précédant sa prise de fonctions avec des personnes morales dont l'activité entre dans le champ des missions de santé publique ou de sécurité sanitaire de l'organisme auprès duquel elle travaille ou de l'instance dont elle est membre ou invitée. Cette déclaration sera rendue publique sauf les mentions afférentes aux liens de parenté ou aux montants financiers déclarés. Cette déclaration répondra à un document type, qui, à terme, devra permettre à une personne qui travaille au sein ou auprès de plusieurs organismes ou de plusieurs instances de ne pas avoir à renseigner ou actualiser plusieurs formulaires. La nature des commissions, conseils et instances collégiales d'expertise dont les débats sont enregistrés est également précisée par le décret.
Références : les dispositions du code de la santé publique modifiées par le présent décret peuvent être consultées, dans leur rédaction résultant de cette modification, sur le site Légifrance (http://www.legifrance.gouv.fr). Il est pris pour l'application de l'article 1er de la loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé.
Publics concernés : entreprises pharmaceutiques, prescripteurs, pharmaciens, la Haute Autorité de santé, l'Institut national du cancer, les centres de référence et de compétence en charge des maladies rares, l'Union nationale des caisses d'assurance maladie, les associations de patients agréées.
Objet : conditions d'élaboration par l'Agence nationale de sécurité du médicament et des produits de santé des recommandations temporaires d'utilisation des spécialités pharmaceutiques.
Entrée en vigueur : le texte entre en vigueur le lendemain de sa publication.
Notice : l'article L. 5121-12-1 du code de la santé publique permet à l'Agence nationale de sécurité du médicament et des produits de santé d'élaborer une recommandation temporaire d'utilisation pour une période maximale de trois ans, autorisant la prescription d'une spécialité pharmaceutique disposant d'une autorisation de mise sur le marché (AMM), dans une indication différente ou des conditions d'utilisation non conformes à son AMM, en l'absence d'alternative médicamenteuse appropriée autorisée.
Le présent décret précise les conditions d'élaboration de ces recommandations et définit leur régime.
Références : les dispositions du code de la santé publique modifiées par le présent décret peuvent être consultées, dans leur rédaction résultant de cette modification, sur le site Légifrance (http://www.legifrance.gouv.fr). Le décret est pris pour l'application de l'article 18 de la loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé.
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The first Pharmacovigilance Risk Assessment Committee (PRAC) will be held on 19 - 20 july 2012 at the European Commission (Brussels).
The European Medicines Agency welcomes the start of new European Union (EU) legislation on pharmacovigilance (2 july 2012). This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.
The Agency is ready for the first meeting of the PRAC on 19 and 20 July 2012. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.
The European Medicines Agency is providing pharmaceutical companies with information on the next steps for the maintenance of information provided on human medicines in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.
Article 57(2), second subparagraph, point c of Regulation (EC) 726/2004 requires marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the European Union as of 2 July 2012 using the updated electronic format provided by the Agency on 5 March 2012.
On 28 June 2012, the Agency hosted a third workshop with European pharmaceutical industry associations on the implementation of this Article, focusing on a proposal for maintenance of information on human medicines. During the workshop, attendees were supportive of the Agency’s proposals, as follows: - Marketing-authorisation holders should submit information on new marketing authorisations granted after 2 July 2012 using the electronic format published by the Agency.The information should be supplied within 15 calendar days from the date of the notification of the granting of the marketing authorisation by the competent authority, including the availability of the approved summary of product characteristics;
- Marketing-authorisation holders should inform the Agency about changes to marketing authorisations using a two-speed system based on expedited and routine notifications. This system will be applied following agreement on the process, which will take place at a follow-up workshop with European pharmaceutical industry associations at the Agency in September 2012.
The Agency will be providing further guidance on both of these issues in the near future.
Implementation of the new Pharmacovigilance legislation European Medicines Agency and Member States Joint Implementation Check-list
Following its adoption on 19 June the Commission Implementing Regulation (EU) 520/2012 on the performance of pharmacovigilance activities has been published in the Official Journal of the European Union. This Implementing Regulation complements the 2010 pharmacovigilance legislation, which starts to apply in July 2012, by providing the more technical details that have to be observed by marketing authorisation holders, national competent authorities and EMA in the daily practice of applying the new legislation. It is therefore an important piece in the new framework, which will promote and protect public health by strengthening the European system for monitoring the safety and use of medicines.
The European Commission has launched a three-month public consultation on a concept paper on the introduction of fees to be charged by the European Medicine Agency for new pharmacovigilance activities. The deadline for comments on the paper is 15 September 2012.
This position paper is intended to provide guidance on how potential medication errors should be addressed in the context of benefit-risk balance assessment and risk minimisation measures. Specifically, the paper focuses on potential medication errors caused by confusion of a newly introduced medicinal product with established medicines that contain the same active substance and are similar in appearance or name but different in some other attributes such as strength, dosing or route of administration.
Consultation end date: 30 november 2012
On this website you can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA). This data is presented in a format called a web report.
Currently the data only relates to medicines approved through the centralised authorisation procedure.
The information on this website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.
Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.
The European Medicines Agency publishes this data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency.
Point d'information sur la nouvelle législation Pharmacovigilance le 5 juin de 13h30 à 17h30 à l'ANSM. Cette réunion est destinée aux laboratoires pharmaceutiques , notamment aux responsables de pharmacovigilance. L'inscription se fait sur invitation uniquement.
The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the pharmacovigilance legislation. The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services.
The document includes answers to frequently asked questions on the following topics: - Good pharmacovigilance practice guidelines;
- Pharmacovigilance system master files and summary of the pharmacovigilance system;
- Risk management plans;
- Post-authorisation safety studies;
- Periodic safety update reports and EU reference date list;
- Literature monitoring;
- Product information and the black symbol;
- Adverse-drug-reaction reporting and signal management;
- Renewals.
Ce set de questions/réponses, mis à jour régulièrement par l'EMA permettra de gérer la période de transition de la mise en place à partir de Juillet 2012 de la nouvelle législation en matière de pharmacovigilance.
This page summarises the types of information that the Agency releases proactively on its activities. In addition, the public has the right to request information and documents from the Agency in accordance with its rules on access to documents and on access to information. The Agency is also developing a transparency policy, which will set out how the Agency intends to provide for greater clarity and openness in all areas of its operations in the future.
Publics concernés : industries du médicament, professionnels de santé, presse professionnelle, patients.
Objet : publicité des médicaments à destination des professionnels de santé et du public.
Entrée en vigueur : les dispositions du présent décret sont applicables :
― pour la publicité à destination des professionnels, aux demandes déposées dans le cadre de la première période de dépôt prévue à l'article L. 5122-9-1 du code de la santé publique suivant la publication du présent décret ;
― pour la publicité à destination du public, aux demandes déposées dans le cadre de la première période de dépôt prévue à l'article R. 5122-5 du code précité suivant la publication du présent décret.
Notice : la loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé a instauré un mécanisme de contrôle a priori pour les publicités à destination des professionnels de santé à l'instar du contrôle en vigueur pour la publicité à destination du public.
Le décret précise les modalités d'application de cette mesure en prévoyant, notamment, un régime d'autorisation tacite des demandes de visa. Il procède également à une actualisation de la partie réglementaire du code de la santé publique relative à la publicité des médicaments.
Références : les dispositions du code de la santé publique modifiées par le présent décret peuvent être consultées, dans leur rédaction résultant de cette modification, sur le site Légifrance (http://www.legifrance.gouv.fr). Il est pris pour l'application du V de l'article 29 la loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé.
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