Current status and prospects of regulations for phage therapy
With the widespread use of antibiotics,more and more drug-resistant pathogens are constantly emerging,posing a huge threat to global public health security.Currently,bacteriophage(phage)therapy has become one of the most important approaches to combating multi-drug resistant bacteria and has been clinically applied in countries of Europe and America,and China.However,there is no special regulation for phage therapy in China,so the investigator-initiated trial has become the main form of phage therapy in China,which restricts the further development and widespread application of phage therapy.Establishing appropriate phage therapy regulations under the current drug regulatory framework is urgent.Therefore,this article first reviews the current situation and regulatory framework of bacteriophage therapy in Georgia,the United States,the United Kingdom,Belgium,and China,aiming to provide a reference for regulating bacteriophage clinical treatment.This article also proposes effective ways to develop bacteriophage therapy in China.Improvement of regulations for bacteriophage clinical application will greatly promote the application of phage therapy in China,effectively curb the crisis of bacterial resistance and better safeguard the health of the people.
Phage therapyDrug legislation and supervisionRegister of new medicineRestrictive medical techniquesProduction of phage preparations
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维普
