medicines-medical devices-regulatory affairs
Last updated: 6 June 2024 See updates at the end of the post. New Paediatric submissions are mandatory via IRIS platform from 4 June 2024 From 4 June 2024, the following types of new paediatric submissions must be submitted out via IRIS: To…
Information on changes to the following guidance documents are provided below: Changes to the Guidance document Time limits for authorisation applications The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for…
Last updated: 23 May 2024 To view updates, click on the ‘+’ sign below. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
The MHRA: The proposed framework is still in draft, and the final version would be integral with the future core regulations. With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will…
AEMPS has launched an accelerated evaluation procedure or fast-track with the aim of making Spain a more attractive environment for research into innovative medicines. In general terms, Regulation (EU) No. 536/2014 on clinical trials of medicinal products for human use establishes the maximum deadlines for…
Last updated: 7 June 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 19 – 20 March 2024 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes…
Last updated: 27 April 2024 See updates at the end of the post. Paediatric submissions on IRIS platform imminent Please note that from 4 June 2024, the the following types of paediatric submissions must be done via IRIS. To ensure a…
Public.Resource.Org, Inc. and Right to Know CLG are both non-profit organisations whose main focus is to make the law freely accessible to all citizens.1 In 2018, they made a request to the European Commission Directorate-General for Internal Market, Industry, Entrepreneurship…
The following updates have been added to this guidance: Further information is available at the link below. Source: MHRA
Date Title of guidance and link to document Type and levelof guidance About the guidance 29 Mar 2024 FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products Final The purpose of…
Last updated: 26 March 2025 To see updates, click the’+’ sign below: This post is an attempt to provide some basic information on Project Orbis, an FDA initiative to facilitate faster access to innovative cancer therapies. An important limitation in…
Last updated: 18 March 2024 See updates at the end of the post. On 27 April 2023, the Commission proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies…