How does E2B improve stakeholders access to ICSR data electronically?
How does E2B improve stakeholders access to ICSR data electronically? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published a short training video on the electronic transmission of ICSRs in E2B (R3) format. This video explains why this format was developed, and its advantages in the exchange of […]
Ways to reduce the influence of promotional activities on health products
The French National Authority for Health (HAS) has recently published a press release on possible ways to reduce the influence of promotional activities on health products. The meeting between health professionals and industry representatives for the promotion of health products is regulated in various ways around the world. In order to establish a state of […]
Re-evaluation of the “Pregnancy” pictogram
The ANSM has just created a temporary scientific committee (CST) “Re-evaluation of the pictogram on the outer packaging of teratogenic or foetotoxic medicinal products” for the re-evaluation of the process concerning the pictogram “Pregnancy” currently mentioned to certain boxes of medicinal products or products whose SmPC mentions teratogenic or foetotoxic effects. To learn more, please […]
The Clock Starts on DAY ZERO For Medical Literature Reports
“Marketing Authorization Holders (MAHs) are expected to review and assess reports of suspected adverse reactions from the medical literature to identify and record Individual Case Safety Reports (ICSRs).” If a pharmacovigilance case is detected in a journal, the clock starts on day ZERO of the receipt of the physical/hard copy of the local journal by […]
Proposals for MA annexes / registrations (SmPC, package leaflet, labelling)
ANSM is updating its MA style sheet to the « full » T10 format. This new version is dated January 19, 2023. The changes concern the address of the adverse reaction reporting site updated by the Ministry of Health https://signalement.social-sante.gouv.fr/ to replace www.signalement-sante.gouv.fr Find the new model to download on https://ansm.sante.fr/documents/reference/recommandations-relatives-a-la-redaction-des-projets-dannexes-de-lamm
The European Commission proposes an extension of the transitional period for the re-certification of medical devices
On 06 January 2023, the European Commission proposed an extension of the transitional period for the re-certification of medical devices in order to reduce any risk of shortages. There are at present more than 500,000 types of medical devices on the EU market, ranging from simple contact lenses and plasters to pacemakers and hip replacements, […]
The European Union In Vitro Diagnostic Medical Devices Regulation (IVDR)
As we approach the end of the IVDR transition period, after May 26, 2022, all new in vitro diagnostic devices and Class A non-sterile IVD devices will need to be IVDR compliant in order to be marketed in the European Union. This means that all manufacturers of CE-marked IVD devices will be affected by the […]
How to qualify for orphan designation in the European Union?
There are more than 7000 rare diseases affecting over 400 million people worldwide and 30 million people in European Union. However, only about 5% of rare diseases currently have approved treatments. As many of these diseases are life-threatening, there is a serious need to develop new drugs for rare diseases. Historically, drug development for rare […]
How to obtain the EMA’s Single Marketing Authorization?
All human medicines derived from biotechnology and other high-tech methods must be evaluated by the European Medicines Agency (EMA) via the centralized procedure called single marketing authorization before they can be marketed and made available to patients in the EU. The evaluation process is carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP) with […]
Webinar – 7 key points for a successful pharmacovigilance inspection
Language – French The pharmacovigilance inspection is one of the most important practice in terms of workload (preparation, implementation of action plans, etc.) and/or in terms of image (in the event of an injunction, for example). During a PV inspection, the pharmacovigilance system, and the involvement of all those stakeholders are scrutinized. This webinar aims […]
