Publications

Hogan Lovells Publications

Podcast: Talking the Cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the the next year, we will touch on cutting edge topics such as...

Insights

Further delay announced regarding the entry into application of the Clinical Trials Regulation
Registered Content

The entry into application of the Clinical Trials Regulation depends on confirmation of full functionality of the Clinical Trial Information System (CTIS) through an independent audit....

News

European Commission publishes new documents regarding the Clinical Trials Regulation

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning theClinical Trials Regulation(EU)...

Insights

European Medicines Agency's guidance on comparability for advanced therapy medicinal products
Registered Content

Changes to the manufacturing process for advanced therapy medicinal products raise questions in terms of comparability. Depending on the criticality of the changes and their impact on the...

Hogan Lovells Publications

View from the Horizon: The regulatory and policy landscape of 2020 and the digital transformation in Silicon Valley

On November 13 the last edition of our global series, Life Sciences and Health Care Horizons, took place in Silicon Valley with discussions focused on the regulatory and policy landscape of ...

Insights

European Commission clarifies implementation of the Clinical Trials Regulation
Registered Content

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the...

News

Heads of Medicines Agencies publishes practical guidance on nitrosamines

In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical...

News

European Medicines Agency’s new guide on the wording of therapeutic indication

On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in...

News

FDA, EMA Address Quality & Manufacturing Issues for Breakthrough Therapies with Expedited Approval

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite...

Loading data