medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
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…
On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs. Until now, Switzerland has been participating in the European Union (EU) internal market for in vitro diagnostic…
Last updated: 31 May 2022 Nitrosamine risk evaluations 1) The following two updated documents can be downloaded from this page: i) NEW – Template for nitrosamine risk evaluation in marketing authorisation applications ii) UPDATE – Step 2 – Nitrosamine detected response…
Post-brexit, there are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) (GB) or Northern Ireland (NI) as shown in the table below. The options available will be determined by: the…
Last updated: 18 June 2022 Some Important dates in the calendar, from a regulatory perspective, are provided in the tables below. This post will be updated on an ad hoc basis. On mobile, the tables are best viewed by scrolling…
This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information under each…
The TGA has published new guidance entitled Good Clinical Practice (GCP) inspection program – Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification…
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 24 September 2021 – 13 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
Last updated: 29 March 2022 Report from the CMDh meeting held on 22-23 February 2022 Included in the report and minutes from the above meeting are the following items: CMDh position on PASS results according to Art. 107q of Directive 2001/83/EC concerning…
Title of guidance Type and level of guidance About the guidance Source Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft guidance This guidance: • is intended to assist applicants and holders of an abbreviated new…