CAR-T cell therapy and bacteriophage therapy fall under the category of personalised medicine. Personalised medicine therapies are new and rare on the market. The desire of all involved in the implementation and setting up of therapies is to treat the patient successfully. Successful treatment is achieved if the therapy is delivered safely, well and effectively. Setting useful regulations to ensure that therapies achieve these characteristics is therefore crucial for the implementation of such therapies. The problem that arises is how to design regulations, for therapies that are not the same as traditional medicines and treatments. The legal authorities had to prescribe the therapies in a specific category of regulations. These regulations must be met for the therapy to be approved for marketing and administration. Both personalised therapies are subject to the regulations that apply to traditional medicines or medicines that are not personalised. Because of the inapplicable regulations, investors are reluctant to invest in such therapies. This is why the prices of the therapies are high and why they are not accessible to the general public. Some countries with an interest in implementing personalised therapies have circumvented the rules. They have modified them, set up their own, or used exceptional examples to carry out therapies. In the future, with the rise of personalised medicine, it may be necessary to set regulations for this category of medicine. Certain treatment levels could be standardised, but specific regulations will need to be added to ensure the correct implementation of individual therapies.
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