The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.”
Category: Product information
TGA opens consultation on use of boxed warnings to highlight safety issues
The Therapeutic Goods Administration (TGA) Australia has opened a consultation on guidance regarding the use of boxed warnings used to highlight serious safety issues. The guidance outlines the objectives for introducing a boxed warning to a Product Information (PI) document, and provides advice on how and when to use a boxed warning. The aim is to ensure consistency across the prescription medicines regulatory framework. Read more “TGA opens consultation on use of boxed warnings to highlight safety issues”
European Commission releases new guideline on excipients in the labelling and package leaflet of medicinal products in the EU
The European Commission has released a new guideline which provides marketing authorisation holders (MAHs) with a list of excipients that should be included on a medicine’s label and the information for those excipients that must appear on the package leaflet. Read more “European Commission releases new guideline on excipients in the labelling and package leaflet of medicinal products in the EU”
TGA publishes information for sponsors on the Black Triangle Scheme
The Therapeutic Goods Administration (TGA) Australia has released information for sponsors regarding the Black Triangle Scheme. Prescription medicines are included in the scheme if they meet one or more of the following criteria: Read more “TGA publishes information for sponsors on the Black Triangle Scheme”
EMA to improve the product information for EU medicines
An action plan has been published by the European Medicines Agency (EMA) to improve the product information (PI) for EU medicines. The PI is an information package for patients and healthcare professionals, which is given with every medicine authorised in the EU, providing information on the safe use of the medicine and how it should be prescribed. Read more “EMA to improve the product information for EU medicines”
TGA to introduce a Black Triangle Scheme from 2018
The Therapeutic Goods Administration (TGA) at the Department of Health for the Australian Government has announced the introduction from January 2018 of their own Black Triangle Scheme, similar to the scheme that is already in place throughout the European Union (EU). The Black Triangle Scheme is useful to alert healthcare professionals and patients to those medicines for which the reporting of all adverse events is considered most important. Read more “TGA to introduce a Black Triangle Scheme from 2018”