Advanced therapeutics

Advanced therapy medicinal products

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a category of medicinal product that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislation regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance.

There are three categories of ATMPs that are based on genes, cells (including stem cells), and tissues, respectively. ATMPs are a type of what is known as regenerative medicine (which refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function and includes cell therapies, tissue engineering, gene therapy and biomedical engineering as well as more traditional treatments

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MHRA publishes blog post highlighting £1.4bn opportunity from medicines reclassification

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a blog post authored by Proprietary Association of Great Britain (PAGB) CEO, Michelle Riddalls OBE, outlining what PAGB describes as a £1.4bn opportunity to transform healthcare through expanded medicines reclassification. Riddalls argues that increasing switches from prescription-only (POM) to pharmacy (P) or general sales list (GSL) status could improve timely access to treatments for common conditions, strengthen self-care and ease pressure on primary care, with the MHRA describing reclassification as a practical way to broaden access to trusted medicines and enable safe self-management of minor conditions. She states that 74% of adults want more medicines available without a prescription, positioning consumer demand as a key driver of switch applications, and frames reclassification as a catalyst for a prevention-focused healthcare model that enhances the role of community pharmacists and supports wider public health goals. Referencing previous switches to over-the-counter (OTC) status, including Nurofen, Allevia and Calpol, as well as low-dose vaginal oestrogen products and Viagra, she highlights both market impact and social significance and calls for reform of the legal framework for certain injectable medicines, pointing to potential benefits in areas including weight management and emergency treatments. Riddalls states that a 5% reduction in NHS prescribing could save £1.4bn annually, with productivity gains of up to £18bn linked to improved OTC symptom management. PAGB adds that reclassification is one of the most practical and impactful opportunities to strengthen self-care and deliver the ambitions of the NHS 10 Year Plan, citing clear opportunity, strong public demand and persuasive supporting evidence.

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