Published on April 15,2021
The UK Passes Medicines and Medical Devices Act
Industry Update
The United Kingdom (UK) has passed an important Act to make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices. The Medicines and Medical Devices Act of 2021, known as MMDA 2021, received royal assent and was passed into law on February 11, 2021.
The Act is designed such as to ensure that regulatory change can be made as and when deemed necessary. It allows for the UK Government to amend legislation on human medicines, clinical trials of human medicines, veterinary medicines and medical devices. The Government say this will ensure that UK legislation is more responsive to new advances in medical technology. This framework is designed so that updates to current legislation must take into account the safety, availability of human medicines and medical devices.
The language in the document focuses on patient safety. This act establishes a framework by which the UK will regulate its pharmaceutical and biotech industries. MMDA 2021 provides punishment for those who violate its terms with civil and criminal sanctions. Other key provisions of the act include:
Powers granted to the Secretary of State for Health and Social Care, to amend current regulations governing human and veterinary medicines, clinical trials, and medical devices
Focus on patient safety
Balance to promote innovation while maintaining public safety
Establishment of a new Commissioner for Public Safety
This unique legislation also allows for broader prescription of low-risk medicines and includes provisions that allow hospitals to develop and provide personalized medicines.
How Can Symbiance AI Help?
Awareness and smarter implementation of clinical activity requirements are key to ensure that regulations and applicable standards are followed. Meeting these requirements will ensure efficient clinical activities, reduce delays and minimize costs and business risks.
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References:
https://www.legislation.gov.uk/ukpga/2021/3/introduction/enacted
