The changes represent the biggest overhaul of UK clinical research legislation  in  more than 20 years, aiming to make the UK one of the best countries in the world to carry out clinical research for patients and researchers.

Under the new system, the  clinical  trial  application process in the UK will be  equal, streamlined and flexible without compromising safety, which will help make the UK an attractive place for trials, including trials. "Global multi-site. For example, the integration of the  legal system and the evaluation of the principles of the  clinical research application, which,  in  the pilot period, reduced the  study  approval  period and reduced the time from the application to the work by 40 days. the first patient,  will  enter  into a new law.


The MHRA will also  include  a  timetable  for  the completion of the review of applications  within a maximum of 30 days, with a maximum  of 10 calendar days for a decision to be issued  once the regulator receives the final information.  Legislative  changes will make the system as possible, support different types of tests and new things,  and  support new ways of conducting tests such as these tests are not guaranteed.

In understanding, the system will introduce legal rights to register the trial in the public register of the World Health Organization (WHO) and the task of publishing a summary of  the  results within 12 months of the end of the trial. Sharing the results of the trial among the  participants in a timely and appropriate  manner will also be required by law.

These changes, which follow public consultation in collaboration with the Health Research Authority (HRA) and the Northern Ireland  Department of  Health, were made with the help of the public and the research community. New guidelines, developed in consultation with the relevant parties, will be introduced to comply with the new regulations. 

This will ensure that UK clinical trials  are truly working in partnership with patients and the public and are representative of the  different types of people who could benefit from the medicine if the data Released after receiving legal approval. The guidelines  will  explain how to include patients in the right way in the design and practice of the test, and how to get the variety in the test in an appropriate  way and get the best results.

Marc Bailey, MHRA's Director of Science and Innovation, said: “Our first global COVID-19 agreement has shown  the importance of ensuring  that legislation is flexible and  flexible. This change in clinical trial law will do just that: it will move us away from a one-size-fits-all approach to  organizing clinical trials and help  improve compliance  by  eliminating unnecessary regulatory requirements.  base.

“This will make the UK one of the best countries in the world to carry out clinical research and get  new  medicines to those who need them more quickly. "We will now work closely with patients and the research community to ensure these changes are implemented as quickly as possible."

Matt Westmore, chief executive of the HRA,  said: "Today's response is a clear and exciting opportunity to ensure that clinical trials will speed up diagnosis, help develop better treatments and enable the NHS to provide life-saving care. world class, while improving  the diagnosis. The UK position. as a life science superpower.

"We are pleased that the response to the recommendation gives us a strong  opportunity to continue our work of setting standards and supporting the research community to improve the value of  public  participation.  The  response to the survey shows that we are all committed to  making  the  best  health research that can benefit the people of the UK, and that we are all working to  support research that people can trust.

Health and Care Secretary Steve Barclay said: "The UK continues to be at the forefront of disruptive clinical trials and these changes - the biggest in 20 years - will make the country a place to work, even attracting the attention of scientists and researchers.

"These changes will speed up clinical trials, without compromising safety, and encourage the development of new and better medicines for patients. They come after the government announced an extra £10m in funding for the MHRA to boost the delivery of expensive treatments,  including  anti-cancer drugs.

These legislative changes coincided with a review of clinical trials led by Lord  O'Shaughnessy and Sir Patrick  Vallance to establish the UK as a scientific institution. They have  established a close relationship with the MHRA over the past few years to provide a more complex system, reducing the complexity of consent and legal proceedings.

These legislative changes  coincided  with  a  review of clinical trials led by Lord  O'Shaughnessy and Sir Patrick  Vallance's work to establish the UK as a scientific powerhouse.  They  have been building a close relationship with the MHRA over the past few  years to provide a more integrated approach, reducing the complexity of judicial approval  and  regulation.