The purpose of this document is to provide general principles to be used when assessing the requests for confidentiality from health technology developers in the context of joint clinical assessments. The specific circumstances in relation...
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament on 12 December 2024. When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials regulation...
EMA is revising its policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’). Stakeholders are invited to comment on the draft revised policy until 10 November 2024 using an online...
The EMA issued a new Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when. The European Medicines Agency (EMA) publishes information on human medicinal products at various...
Revised rules for Clinical Trials Information System (CTIS) become applicable The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials...
Reform of the EU Pharmaceutical Legislation: factsheet on ‘A single market for medicines putting patients at the centre’. Read the publication by EC Directorate-General for Health and Food Safety on 22 May 2024.
The presentation material and video recording of the CTIS bitesize talk – Training materials, CTIS pre-requisites, and updates on transparency rules held on 29 November 2023 have been made available on the EMA Website. This...
EMA has revised its transparency rules for publishing information on clinical trials submitted through CTIS. The revised rules enable easier access to clinical trial information, and ensure a balance between transparency and protection of commercially confidential information. These changes benefit patients, healthcare professionals and...
Letters requesting a set of regulators to update their strategic approach to AI, with the intention of increasing the transparency around how they are implementing the AI Regulation White Paper proposals. Read the press release from...
In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. Despite considerable progress in transitioning to these rules and the...
