Comments on new MHRA clinical trial regulations
Commenting on the that it will introduce new legislation today to create a more efficient, streamlined and adaptable regulatory framework for clinical trials, Matthew Alderton, Partner in the health and life sciences team at UK and Ireland law firm 澳门六合彩资料, said:
鈥淭his new legislation will be welcomed with open arms by the life sciences industry, which has for a long time been calling for measures to streamline the slow and cumbersome clinical trials process.
鈥淏y removing granular and duplicative requirements in the proposed new framework, standardising the approvals and contracting process to reduce set-up times, and providing more flexibility at a broader level to the clinical research environment, there is real hope this can drive new inward investment and international market entrants into UK life sciences.
鈥淔or patients, breaking down barriers to participation in clinical trials could also have a profound impact on tackling health inequalities, as widening and diversifying the pool of participants will ensure new treatments are being tested on people from all walks of life rather than a narrow sample.
鈥淭he MHRA鈥檚 research and ethics committee will continue to run a robust review of clinical trial applications, which means providers running trials should ensure they still have all the necessary policies and procedures in place to take advantage of a smoother regulatory process.
鈥淎longside new legislation, the clinical trial community will hope to see new clear, concise and pragmatic guidance follow to help companies prepare for the upcoming changes, while a well-resourced and highly skilled MHRA remains a priority for the industry in order to effectively implement the intended reform.鈥
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