Drugs: Licensing

(asked on 12th November 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what the assessment rate is for UK national drug licences by the Medicines and Healthcare products Regulatory Agency as at 12 November 2021; and what steps his Department is taking to improve that assessment rate.


Answered by
Maria Caulfield Portrait
Maria Caulfield
Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
This question was answered on 15th February 2022

As of 12 November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) granted 832 Marketing Authorisation applications with an average net determination time of 216 days. This is comparable to previous determination times in 2019, where 859 applications were determined in an average of 227 days and 670 applications were determined in an average of 220 days in 2020.

The MHRA is implementing a new operating model, combining diagnostics, medicines, vaccines, medical devices and digital technologies to deliver risk-proportionate regulation. The MHRA will ensure that products can reach the market more quickly, whilst addressing any safety concerns.

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