medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
This post will be updated on an ad hoc basis. Report from the CMDh meeting held on 12-13 October 2021 Some items of note in this report include the following: CMDh Best Practice Guide on Multilingual Packaging The CMDh has…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 27 September 2021 is covered. On mobile, the table is best viewed by scrolling sideways.…
19 October Predictive models suggest COVID reinfections likely within one or two years People who have been infected with SARS-CoV-2 can expect to become reinfected within one or two years, unless they take precautions such as getting vaccinated and wearing masks.…
In September 2021, the European Medicines Agency (EMA) provided final feedback was provided to the European Commission (EC) on its request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives in medicinal…
This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…
Title of guidance Type and level of guidance About the guidance Source Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS This document is unpublished. It is scheduled to be published on 14 Oct 2021. Draft, Level 1 guidance The draft…
Last updated: 5 October 2021. See updates at the end of this post. The UK MHRA has published guidance on the the Innovative Licensing and Access Pathway (ILAP) for medicines. It aims to accelerate the time to market, facilitating patient…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-24 Guidance on classification of medical devicesThe purpose of this chapter is to provide a general overview on the impact of the classification of medical…
Last updated: 30 September 2021 Title of guidance Type and level of guidance About the guidance Source Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers This guidance provides information for firms about how FDA…
The TGA, Australia has implemented a Data Protection Scheme for assessed listed medicines and published guidance to facilitate the scheme. What is the scope of the guidance? The guidance provides: an overview of the Data Protection Scheme for Assessed Listed…