National Accelerated Licensing Routes to Improve Clinical Trial Supply
The Medicines and Healthcare Products Regulatory Agency (MHRA) has released its 2020-21 business plan, outlining its primary goals for the coming year. Driven by the need to develop new regulatory models and improving patient access to cutting-edge drugs and medical devices, the plan concerns various aspects of the British life sciences industry, including the efficacy and efficiency of clinical trial supplies.
In the executive summary, the plan sets out the primary aim of “driving forward a substantial strategic and cultural change through 2020-21”. Though the document discusses a range of granular challenges in healthcare and medicine, two of the biggest issues covered are the far-reaching impacts of the ongoing coronavirus pandemic and the uncertainty surrounding Brexit planning. Each of these factors has led to concerns in future clinical trial supplies and the security of drug supply in the UK. The MHRA’s mission is to protect public health by finding ways to avoid those outcomes.
Two promising aspects of the MHRA strategy from a clinical trial supply perspective come under the remit of accelerated licensing routes and improvements to biosimilar approval:
- In 2020-21, the MHRA will develop the National Accelerated Licensing route to operate from 1st January 2021, and publish the relevant guidance, so that innovative products submitted to the UK can be authorized with a shorter timeline;
- Develop and publish guidance on new innovative UK licensing procedures for biosimilar products to likewise operate from 1st January 2021 and reduce the burden placed on clinical trial data generation.
Though there are significant ongoing pressures facing the UK’s health system from patients at the ground level to decision-makers in charge of ongoing clinical trials, the MHRA’s business plan sets out a concrete strategy for rising to the challenge.
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