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11 December 2020

Clinical Trial Regulation 536/2014 – Preparing for a successful transformation

Kate Moss

Kate Moss
Partner | Pharmaceuticals and lifesciences | London

The European Medicines Agency has announced that CT Regulation 536/2014 is expected to go live at the end of 2021. This regulation builds on the Clinical Trial Directive and will be one of the most impactful regulations shaping the industry. It requires organisations to make fundamental changes and enable a cultural shift. It is applicable to any organisation that wishes to run interventional clinical trials or is planning for market authorisation in the European Union region. The scope also extends to independent regulatory and ethical bodies in all member states of the EU.

The regulation introduces a number of requirements, including new processes that impose strict timelines to adhere to and a new Clinical Trial Information System that is a single, harmonised platform where all of the obligations will need to be performed:

  • Clinical Trial Application submission and assessment
  • Notification and management of clinical trial milestones and events, and Clinical Study Report
  • Safety notification and reporting, and
  • Clinical trial data transparency and publication.

Delivering the transition required by the new regulatory obligations could take organisations months or even years, depending on their current clinical trial environment and maturity level.

Nonetheless, once the regulation is effective, it will achieve harmonisation in the clinical trial application process across the region, and foster healthy collaboration amongst regulators and sponsors. More importantly, it will deliver significant benefit for the patient community, as it promotes greater transparency by ensuring that all necessary information is made public at the right time.

Why wait? Start preparing for your successful transformation now.

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