La réglementation du médicament ne cesse de s'enrichir et vous n'avez pas toujours le temps de trouver l'information, de la digérer et de la transmettre à vos équipes.
La société Evelyne Pierron Consultants met à la disposition des départements PV, Affaires Réglementaires une plateforme d'information et des outils vous permettant de vous tenir à jour sans panique. Visitez mon site www.epconsultantsonline.fr et rejoignez la communauté.
De nombreux services vous attendent.
En attendant votre visite, Evelyne Pierron Consultants continue de veiller sur sa communauté.
Thirty-nine medicines for human use were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012.
“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.
EVELYNE PIERRON's insight:
Drug and device makers who send social media messages on services like Twitter will be required to include the risks and benefits of their products when they do so, the Food and Drug Administration proposed today in two draft guidelines.
The European Medicines Agency (EMA) has released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, for a two-month public consultation.
All stakeholders are invited to send comments on the draft guidance document no later than 27 July 2014.
Pour faciliter la notification de ces événements indésirables médicamenteux, les 6 centres de pharmacovigilance d’Ile de France se sont regroupés au sein d’une coordination et mettent à disposition depuis Février 2014 un site internet de télé-déclaration : www.pharmacovigilance-iledefrance.fr.
EVELYNE PIERRON's insight:
Ce site s’organise en 2 espaces:
- l’un destiné au grand public,
- l’autre aux professionnels de santé.
Pour accéder à l’espace qui lui est dédié, le professionnel de santé se crée un compte à l’aide de son n° RPPS (pour les médecins, pharmaciens, chirurgien-dentistes, sages-femmes) ou de son n° ADELI (pour les infirmiers(ères)). Il pourra ensuite déclarer un effet indésirable avec un formulaire spécifique aux professionnels de santé, poser une question sur la iatrogénèse médicamenteuse et le bon usage des médicaments, ou encore accéder à des informations utiles à sa pratique quotidienne.
Par ailleurs, un abonnement au flux RSS permettra à ces professionnels de santé de recevoir les alertes et les brèves de pharmacovigilance dès leur mise en ligne.
These are intended to allow stakeholders wider access to the information behind the decision-making process of European regulatory authorities when they review the safety of a medicine or active substance.
The report, covering the period from 1 January to 31 December 2013, shows a 26% increase in expedited ADR reports over 2012, resulting in the highest ever annual figure. The greatest increase occurred within the European Union (EU), showing the combined effort of the EU medicines regulatory network to encourage reporting to of suspected adverse reactions to medicines.
Letter from JAMA Internal Medicine — Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012
EVELYNE PIERRON's insight:
The objective of this study was to determine the frequency of premarket and postmarket boxed warnings and safety-related withdrawals for novel therapeutics approved between 1996 and 2012.
Our study demonstrates that boxed warnings are common, affecting more than one-third of recent drug approvals. While nearly three-quarters of boxed warnings had been applied to novel therapeutics at the time of approval, more than 40% acquired the warning after a median market period of 4 years.
The European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.
Companies need to complete this process by the end of 2014.
The new EU pharmacovigilance legislation became operational in July 2012, and after 18 months of operation, the authors suggest that this initiative is starting to demonstrate results in terms of patient safety, and that there could be wider implications in terms of more safe and effective drugs being made available in the future.
The European Medicines Agency (EMA) has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation. The EMA, the national competent authorities in the Member States and the European Commission have collaborated closely in fulfilling their responsibilities for implementing the new legislation.
This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA.
The European Parliament voted in favour of an EU Regulation on fees payable to the European Medicines Agency(EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees.
It defines two types of fees, in view of the diversity of the pharmacovigilance activities: procedure-based fees and an annual fee.The procedure-based fees are aimed at covering the cost of the EU-wide assessments including financial compensation of the national competent authorities for the rapporteurships.
The annual fee covers mainly EMA’s information technology-related activities for pharmacovigilance.
Therefore, the first procedure-based fees should be charged around August or September 2014. The annual fee will be charged as of 1 July 2015.
MHRA and NHS England have jointly issued two patient safety alerts and supporting guidance to help simplify reporting and help healthcare providers increase incident reporting involving medication errors and medical devices.
This work is the result of extensive stakeholder engagement and aims to increase the quantity and quality of adverse incident reports to both organisations. It will also enable us to provide effective and regular feedback to healthcare providers in order to promote patient safety.