Medicines and Healthcare products Regulatory Agency: Small Businesses

(asked on 19th October 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions his Department has had with stakeholders on the potential merits of expanding the scope of the Medicines and Healthcare products Regulatory Agency's Innovation Office to support UK-based SMEs in a similar way to the European Medicines Agency’s SME office.


Answered by
Edward Argar Portrait
Edward Argar
Minister of State (Ministry of Justice)
This question was answered on 22nd November 2021

There are regular discussions between the Department and the Medicines and Healthcare products Regulatory Agency (MHRA) relating to ongoing work with global regulators. The MHRA is committed to continuing cooperation with international fora, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Coalition of Medicines Regulatory Authorities.

The MHRA currently has no plans to establish a small and medium-sized enterprise (SME) office, as there are a number of incentives that provide benefits and assistance to SMEs. The MHRA’s Innovation Office provides free, high level regulatory advice designed to be accessible to small product developers, such as SMEs, academic institutions and individuals, which are unfamiliar with the regulatory system.

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