Under a joint information-sharing agreement, the government is planning parallel decision-making for access to medicines.
Under a joint information sharing agreement, pharmaceutical companies will be invited to register early with the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) to allow parallel decision-making over licensing and value. This means that patients should receive medicines up to six months faster.
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 and provides a clearer route to help get their treatments to patients.
“Streamlining approval processes will allow both agencies to give patients earlier and equitable access to the innovative medicines needed to improve UK health outcomes,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry.
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.
