Eu clinical trials directive in the uk

By gathering key facts together, such as phase of study, therapeutic area, countries, number of sites, and the length of trial, we are able to provide representation suited to the precise needs of the sponsor and the study. Beyond that, ARG seeks to build a structure that can be maintained throughout the cycle of the partnership, focusing on next-level considerations, such as explaining the legal implications of managing a single project vs.

ARG has the ability, personnel and knowledge to ensure clinical trials are run to the applicable standards and regulations. Along with our professional legal services, each part of the project is cared for with individual attention. With over 20 years experience of running clinical trials in Europe, sponsors can rest assured we have the process in place to ensure compliance and oversight of their trials. Currently lacking an EU Office? Aware of statutes and regulations in the European Union?

Up-to-date with EMA updates to requirements and obligations? The Legal Representative Help sponsors understand the regulatory requirements Put together a customized solution to ensure compliance Stay up-to-date on and communicate EU legal requirements Assist in coordinating site inspections to comply with the International Conference of Harmonisation ICH and Good Clinical Practice GCP Prepare clinical trial authorisations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities.

These should be documented so that the information is available promptly on request by MRC head office or others. MRC, or more accurately UKRI, will only consider accepting trial sponsor responsibilities in very limited circumstances.

For UKRI to accept sponsorship, all of the following must apply:. UKRI may also agree to co-sponsor projects with another research organisation under certain circumstances, subject to appropriate agreements and controls, and providing that the above criteria are fulfilled. UKRI will review whether they will accept sponsorship responsibility on a case by case basis. Please contact us to discuss. Clinical trials involving human participants must have appropriate ethics and regulatory approvals before the trial starts.

Investigators and research organisations should review their systems for good clinical practice and safety reporting, based on a thorough analysis of the trial risks, the systems in place to manage the risks, and the regulatory requirements. Investigators undertaking global health trials should refer to the MRC guidance on the management of global health trials.

The MHRA is committed to taking a risk-based approach to its responsibility for inspection. Systems appropriate to one kind of trial should not be applied to other kinds of trial for which the risk profile is different.

Nor does a free trade agreement remove customs formalities and controls, including those concerning the origin of goods and their input, as well as prohibitions and restrictions for imports and exports. This authorisation is also required if only part of the manufacturing e. The qualified person is responsible for ensuring that each production batch of an investigational medicinal product intended.

However, in view of the timelines set in its Article 99, this Regulation is not going to apply before the end of the transition period. After the end of the transition period, these rules will apply to investigational medicinal products imported from the United Kingdom into the EU.