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How Is the New Regulatory Framework Around Point of Care Manufacturing Going to Impact Pharma?

on Tuesday, 07 September 2021.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation asking the medical community, patients and the public for their views on its proposed plans for a new regulatory framework for Point of Care (POC) manufacturing.

POC manufacturing involves the manufacturing of personalised medicines for patients at or near to where they receive care.These medicines need to be manufactured close to the patient because of their intended use or because they have a very short self-life (sometimes only minutes). Examples of POC products include cell therapy treatments and 3D printed products (such as patient specific prosthetics).

The hope of the MHRA is that the proposed regulatory changes will help to ensure access to innovative new medical products to patients, thereby increasing opportunities for additional treatment options for patients through POC products. The plan is to link this new regulatory framework to existing regulatory systems for clinical trials and safety monitoring to provide reassurance that POC products are meeting the same level of safety, quality and efficacy which is in place for conventional medical products.The MHRA has commented that the need for change in this area is important for the safety of patients and in order to ensure regulation keeps pace with innovation.

The MHRA has asked for the views of industry, the medical community, patients and the public on the proposed plans in order to ensure the views of these stakeholders are "at the heart of [the MHRA's] decision making" in relation to regulatory change and implementation.

The public consultation opened on 12 August 2021 and will run for six weeks until 23 September 2021. A link to the consultation can be found here.

PING Conference 2021

The 2021 PING Conference, which VWV will be holding in collaboration with IQVIA, is entitled 'UK Life Sciences Opportunities in a Changed World'. The Conference will look at many ways in which the UK is now innovating and bringing new treatments to patients. This will include hearing from Blake Dark, Interim Chief Commercial Officer at NHS England and Improvement, who will be speaking about 'NHS Commercial Medicines: Securing innovative treatments for patients'. Find out more about the event here.

For more information on the new regulatory framework please contact Laura Barrell in our Pharmaceuticals and Life Sciences team on 01923 919 313, or complete the form below.


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