Source: UK Government
The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, with improved efficiency and flexibility, readying the MHRA for a new era in medicines approvals in the UK.
Central to realising this ambition is how the ILAP provides a single integrated platform for sustained collaborative working between the MHRA, partners and the medicine developer.
By harnessing expertise at the right time from the MHRA’s partners, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I), the ILAP allows for enhanced coordination and monitoring of important product development activities. Patients are also key partners and the patient voice will be integrated at every stage.
23 December 2020
The MHRA has issued an authorisation to the Department of Health and Social Care to allow the use of the NHS Test and Trace COVID-19 Self-Test kit to detect infection in asymptomatic individuals.
This is an antigen lateral flow test (antigen LFT) which can give a result in 30 minutes.
The device can be used to identify new cases of COVID-19 in people who do not have symptoms. Anyone receiving a positive test should follow the information in the instructions for use provided with the kit.
A negative test result means that the test has not detected the presence of the COVID-19 virus, at the time the test was taken. Anyone receiving a negative test result should continue to follow the latest guidance for their area.
As is the case for current, licensed vaccines, the quality of each batch of any potential COVID-19 vaccine will be evaluated by an independent laboratory. The independent laboratory will also carry out a thorough review of the manufacturer batch documentation that describes the production process and quality control testing performed by the company.
In the UK, this independent testing is performed by the National Institute for Biological Standards and Control (NIBSC), an expert centre of the Medicines and Healthcare products Regulatory Agency (MHRA).
Before any batch can be released for deployment, the NIBSC will issue a certificate confirming that the independent testing has been performed and that the batch is compliant with the relevant specifications for the product.
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