Category: European
-
Short Note on Regulation (EU) No 536/2014 on Clinical Trials
Regulation (EU) No 536/2014, enacted by the European Parliament and the Council on April 16, 2014, provides a comprehensive framework for the conduct of clinical trials on medicinal products for human use within the EU. It aims to ensure the protection of participants’ rights, safety, and well-being while facilitating the efficient and ethical conduct of…
-
The EU Decentralised Clinical Trials Project: Revolutionizing Clinical Research
Background The landscape of clinical trials in the European Union (EU) is evolving, driven by the need for innovative trial designs and methodologies that address both emerging opportunities and inherent challenges. The EU Decentralised Clinical Trials (DCT) project is a pioneering initiative aimed at transforming the traditional clinical trial framework to enhance accessibility and convenience…
-
Advanced therapy medicinal products (ATMPs)
Advanced therapy medicinal products (ATMPs) What are ATMPs? Advanced therapy medicinal products (ATMPs) are a new and innovative type of medicine that uses genes, tissues, or cells to treat or prevent diseases. They work by repairing, replacing, or supplementing damaged or diseased cells and tissues. ATMPs can be used to treat a wide range of…
-
Adaptive Pathways for Medicine Development
Adaptive pathways is an approach to medicine development that is based on iterative development, confirming benefit-risk balance, and gathering real world data. It applies to treatments in areas of high medical need. The European Medicines Agency (EMA) defines adaptive pathways as a flexible approach to clinical trial design, data analysis, and regulatory review that allows…
-
Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA: Chapter 3 of this comprehensive guide ventures into the heart of the electronic submission process for medicinal product information to the European Medicines Agency (EMA). This…
-
Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 2: Electronic submission of information on medicinal products by MAH of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA : Chapter 2 of this detailed guide dives into the various avenues available for marketing authorization holders (MAHs) to electronically submit information on their medicinal products for…
-
Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA : This chapter serves as the introduction to the comprehensive guide on electronically submitting information on medicinal products for human use to the European Medicines Agency (EMA) by marketing authorization holders (MAHs). With…
-
Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004
Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004: Article 57(2) of Regulation (EC) No 726/2004, as amended by later regulations, plays a crucial role in ensuring the European Medicines Agency (EMA) has a comprehensive overview of all authorized medicines within the European Union (EU) and…
-
Electronic submission of medicinal product information by marketing-authorisation holders
Electronic submission of medicinal product information by marketing-authorisation holders In the dynamic landscape of pharmaceutical regulation, the European Union (EU) stands at the forefront of ensuring the safety and efficacy of medicinal products. One pivotal aspect of this regulatory framework is the submission of comprehensive product information by marketing-authorisation holders (MAHs). Traditionally, this process involved extensive paperwork,…