This Act makes provision for a Commissioner for Patient Safety to oversee the management and safety of medicines and medical devices, and confers power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; and makes provision to enforce regulations, and protect health and safety in relation to medical devices. The Act also makes provision for innovative regulation of novel therapies and updates existing clinical trials regulations. As well as improving the regulatory framework to manage innovations such as Artificial Intelligence, proposals under the Act will seek to be consistent with the ambition of the Policy Paper: Regulation of the Fourth Industrial Revolution.
