Before a pharmaceutical drug is launched on to the market, it goes through years of research and development and are required to undergo pre-clinical and clinical testing. The pressures on the costs involved have increased over the years as the regulatory framework has grown in complexity and the requirements governing the production of a new product's proof of efficacy, safety and quality have tightened across the globe.
To maximize this costly investment, pharmaceutical companies have a strong interest in testing new products in multiple markets worldwide simultaneously. Although some of the key concepts and rules governing the conduct of clinical trials and research are to a certain extent harmonized in some parts of the world, important differences are still manifold.
The Clinical Trials Handbook outlines the basic legal framework governing clinical trials of medicinal products and addresses some of the most important legal issues in this area. It answers the following questions across 34 jurisdictions:
- Who are the regulators of clinical trials?
- What is the basic legal framework governing clinical trials?
- What must be considered in the context of clinical trial agreements?
- What are the functions and obligations of a sponsor and a CRO?
- What are the functions and responsibilities of an investigator?
- Who finances the supply of study drugs?
- What are the key rules regarding legal liability in clinical trials?
- Are there specific requirements relating to the publication of study results?
- Who is entitled to inventions and other IP rights resulting from a trial?
- Are investigator initiated trials permissible?
This handbook is an invaluable resource for all lawyers dealing with both single and multi-jurisdictional clinical trials by helping to facilitate their basic understanding of the rules and regulations to conduct clinical trials across a broad spectrum of global markets.
Click on the links below to access each chapter.
Please refer to the EU Clinical Trials Regulations Overview for EU member states.
*Note: The UK and EU agreed to an implementation period that will start on 30 March 2019 and last until 31 December 2020. During this time, the UK will no longer be a Member State of the European Union, but market access will continue on current terms. The UK and the EU have agreed that EU rules and regulations will remain in place in order to provide continuity and certainty to businesses and citizens.
The EU’s new Clinical Trials Regulation is expected to be implemented during 2020 and would apply to the UK under the terms of the time-limited implementation period.