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MHRA, NICE to coordinate for speedy drug approvals

New drugs approval

Pharmaceutical companies will be invited to register early with MHRA and NICE to allow parallel decision-making over licencing and value

Key Summary

  • Both agencies will carry out parallel decision-making over licencing and value
  • Patients in England will receive the newest medicines 3-6 months earlier
  • This will help businesses cut their administrative costs by 25 percent

The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) have claimed that their information-sharing agreement will lead to faster access to medicines for NHS England patients.

Pharmaceutical companies will be invited to register early with both agencies to allow parallel decision-making over licencing and value.


Hence, medicines will receive approval for use on the NHS in England at the same time as they are licensed for use in the UK.

As a result, patients in England will receive the newest medicines 3-6 months earlier.

As part of the 10-Year Health Plan and industrial strategy, the new joint service would cut administrative costs for businesses by 25 percent.

The enhanced coordinated approach offers medicine developers an integrated advice service and an aligned pathway to help them streamline both regulatory and Health Technology Assessment (HTA) requirements.

To benefit from this service, companies should register their products on UK PharmaScan, the national horizon scanning database, at least three years before their expected marketing authorisation.

Health secretary Wes Streeting said, “This government is slashing red tape and turbocharging economic growth of the life sciences sector so patients can get the innovative treatments they need, faster."

By having two of our most important regulators join forces, we’ll rapidly remove barriers, get patients access to vital medicines, and grow the economy, he added.

MHRA chief executive, Lawrence Tallon, said, “This marks an important step in delivering smarter regulation – strengthening UK’s global life sciences offer and reinforcing our position as an attractive destination for innovation and international investment.”

NICE chief executive Dr Sam Roberts said, “This joint working with our partners at the MHRA will allow us to accelerate medicines into the NHS even further to help transform the health of the nation, alleviate pressure on the service where possible and support a thriving life sciences sector in this country.”