Actu Pharmacovigilance

L'agence européenne (EMA) a mis en ligne sur son site les modules/annexes des Bonnes Pratiques de Pharmacovigilance (BPPV) finalisées et en consultation publique le module VII révision 1 (PSURs) a été mis en consultation publique jusqu'au 25 juin 2013. Cette révision tient compte de la version finalisée du guideline ICHE2CR(2)

Les documents finalisés sont les suivants:

- Le module X "Additional Monitoring", version finale a été publiée ce jour

- Des clarifications ont été appportées au module VIII rev 1 PASS

- tous les guidelines ICH ont été regroupés dans l'Annexe IV des BPPV

- toutes les abbréviations utilisées sont regroupées dans l'Annexe V des BPPV

- une annexe III a été créée afin de lister tous les textes et recommandations développés avec la législation.

La page du site web de l'EMA a été également revue afin de ne recenser que les modules finalisés et en cours de consultation.

Les anciens documents sont archivés au niveau de ce lien.

Almost 62% of the patients in pivotal trials submitted in marketing-authorisation applications (MAAs) to the European Medicines Agency between January 2005 and December 2011 were recruited outside of the European Economic Area (EEA) and Switzerland, according to an analysis performed by the Agency.

The report on clinical trials submitted in MAAs to the European Medicines Agency, published today, provides an overview of the distribution of the numbers of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the Agency, as well as the number and location of sites that were inspected.

L'ANSM a mis en ligne sur son site le Bulletin des vigilances n°57 (Mars 2013).

Dans son édito, le bulletin aborde les nouvelles procédures européennes d’arbitrage s’appliquant dès lors qu’un médicament est autorisé dans plus d’un Etat Membre et ceci quel que soit le type d’enregistrement. En pharmacovigilance, les deux procédures les plus utilisées sont la procédure selon l’article 107i dite procédure d’urgence et la procédure selon l’article 31 de la directive 2001/83 amendée qui permet une réévaluation globale du rapport B/R et en dehors d’un contexte d’urgence.

Un rappel sur les dernières actualités en pharmacovigilance (point d’info, lettre aux prescripteurs) est présenté dans la rubrique pharmacovigilance.

Des signalements en chiffre des déclarations de pharmacovigilance et erreurs médicamenteuses sont présentés sous forme de diagramme.

This module focuses on vaccine-specific aspects and unique challenges that should be borne in mind when designing and implementing pharmacovigilance activities for vaccines.

A public consultation is opened until 12th June 2013.

A new page on the EMA's website. This page provides guidance to marketing-authorisation holders on submitting risk-management plans to the European Medicines Agency.

Risk-management plans include information on:

• a medicine's safety profile;
• how its risks will be prevented or minimised in patients;
• plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine;
• risk factors for developing side effects;
• measuring the effectiveness of risk-minimisation measures.

L'ANSM a publié ce jour à l'instar de l'agence européenne (EMA), un set de questions réponses à la suite de la publication du décret de pharmacovigilance du 8 novembre 2012 relatif au système de pharmacovigilance, la personne référente de PV, la déclaration des effets indésirables, les plans de gestions des risques, les PSURs.

The European Medicines Agency has simplified the process of submission of applications for centrally authorised medicines, reducing the number of applications companies now need to submit.

The PRAC maintains a list of medicines under additional monitoring in the EU, which it updates every month. For more information, see the list of medicines under additional monitoring.

Additional monitoring status may be assigned to a medicine when it is approved for the first time or at any time during its life cycle. A medicine remains under additional monitoring for 5 years or until the PRAC decides to remove it from the list.

There may be a delay between the Agency's decision to add or remove a medicine from this list and the time when the updated package leaflet comes into circulation. This is because it takes some time for the updated package leaflet to be printed and to gradually substitute older versions already on the market.

In case of any uncertainty, always check the list on the Agency’s website, which is reviewed every month and is constantly up-to-date.

At the current list, next anticancer medicines are subject of additional monitoring in the EU:

• Brentuximab vedotin (New active substance, conditional authorisation, post-authorisation safety study: a study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug)
• Ofatumumab (Conditonal authorisation, post-authorisation safety study: a study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug)
• Nelarabine (Authorised under exceptional circumstances)
• Bosutinib (New active substance, conditional authorisation, post-authorisation safety study: a study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug)
• Vandetanib (New active substance, conditional authorisation)
• Decitabine (New active substance)
• Clofarabine (Authorised under exceptional circumstances)
• Eribuline mesylate (New active substance)
• Axitinib (New active substance)
• Ruxolitinib (New active substance, post-authorisation safety study: a study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug)
• Cabazitaxel (New active substance)
• Pertuzumab (New active substance)
• Pixantrone (New active substance, conditional authorisation)
• Tegafur / gimeracil / oteracil (New active substance)
• Lapatinib (Conditional authorisation)
• Panitumumab (Conditional authorisation)
• Everolimus (Conditional authorisation)
• Anagrelide (Authorised under exceptional circumstances)
• Crizotinib (New active substance, conditional authorisation)
• Denosumab (New biological)
• Ipilimumab (New active substance, post-authorisation safety study: a study designed to confirm, further characterise or refute a safety signal which has been associated with a specific drug)
• Trabectedine (Authorised under exceptional circumstances)
• Aflibercept (New active substance)
• Vemurafenib (New active substance)
• Abiraterone (New active substance)

The European Medicines Agency has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP).

The new database, now called EudraGMDP, is a key deliverable of the new European Falsified Medicines Directive, which came into force in January 2013. It will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.

On 1 April 2013, the European Medicines Agency will start carrying out single assessments of periodic safety update reports (PSURs) of active substances contained in both centrally and nationally authorised medicines.

The new single assessment means that the Agency will analyse all of the reports for medicines containing a particular active substance, for all types of marketing authorisation and for medicines authorised in more than one Member State. Until now, the Agency has only been assessing PSURs for centrally authorised medicines.

During 2013, the single assessment will cover active substances contained in centrally authorised medicines and active substances found in both centrally and nationally authorised medicines. Active substances only found in nationally authorised medicines will not be subject to a centralised assessment by the Agency until after 2013.

A new page on the EMA's website. This page is useful where we can find the previous versions of GVP chapters and final versions with tracked changes.

Le décret n° 2012-1201 du 29 octobre 2012 , entré en vigueur le 1er  avril 2013, fixe les règles d’étiquetage des préparations magistrales, officinales et hospitalières.

Afin de faciliter la mise en œuvre d’étiquetages conformes aux dispositions de ce décret et dans la perspective d’assurer au mieux la sécurité et la traçabilité des préparations, l’ANSM :

• préconise de suivre les recommandations détaillées ci-après
• propose des modèles d’étiquettes et une liste de mentions requises pour chaque type de situations, à télécharger.

Belle infographie sur le marché des pilules commercialisées (taux de remboursement, prix, génériques) en France depuis 1969 jusqu'à ce jour

This year, the Agency's priorities are to:

• continue to ensure that assessment activities are conducted to the highest levels of quality and of regulatory and scientific consistency;
• continue to implement the pharmacovigilance legislation, depending on resources;
• continue to prepare for the implementation of the falsified-medicines legislation;
• prepare for the outcome of the European Commission's impact assessment on revision of the veterinary-medicines legislation;
• further develop the communication and transparency activities of the Agency.

L'agence européenne a mis à jour le template du RCP/notice afin de permettre une identification aisée des médicaments faisant l'objet d'une surveillance supplémentaire.

Ce nouveau template inclut le nouveau symbole noir (triangle inversé) pour tous les médicaments faisant l'objet d'une surveillance et l'encouragement au reporting des effets indésirables par les patients et professionnels de santé au système national de pharmacovigilance.

A compter de Septembre 2013, les laboratoires devront se soumettre à cette nouvelle législation.