What are the types of special review for drugs?

Special review for drugs is designed to accelerate the marketing of new drugs, especially those with significant clinical advantages or used to treat serious diseases. Here are some types of special review in different countries and regions:

China: 

·Breakthrough Therapy Designation: For innovative or improved new drugs for the prevention and treatment of serious life-threatening or quality of life-impairing diseases, with no effective treatment options or sufficient evidence showing significant clinical advantage over existing treatments. 

·Conditional Approval: For drugs treating serious life-threatening diseases with no effective treatments, where clinical trial data has demonstrated efficacy and can predict clinical value. 

·Priority Review and Approval: For innovative or improved new drugs for clinical urgent needs, prevention and treatment of major infectious diseases, rare diseases etc. 

·Special Approval Procedure: In the event of a public health emergency threat or occurrence, the National Medical Products Administration can decide on emergency drugs needed for prevention and control in accordance with the law.

United States: 

·Orphan Drug Designation: For development of drugs for rare diseases. 

·Fast Track Designation: Aims to accelerate the review process for important new drugs for serious conditions and unmet medical needs. 

·Breakthrough Therapy Designation: For drugs with preliminary clinical evidence indicating potential for substantial improvement over available therapies on a clinically significant endpoint.

·Priority Review Designation: Provides review priority for drugs that treat serious conditions and demonstrate significant safety/efficacy improvements. 

·Accelerated Approval: Allows approval based on surrogate or intermediate clinical endpoints, with subsequent confirmatory studies required.

European Union: 

·Orphan Drugs: Encourages development of drugs for rare diseases.

·Exceptional Circumstances: For drugs of major public health interest, major therapeutic advantage or significant patient benefit. 

·Conditional Marketing Authorization: Allows accelerated approval based on incomplete data, with confirmatory studies required subsequently. 

·Accelerated Assessment: For drugs of major public health interest. 

·PRIME (Priority Medicines): Provides early support and accelerated assessment for drugs addressing unmet medical needs.

The establishment of these special review pathways aims to accelerate the approval process for drugs with significant clinical value, rapidly responding to medical needs and public health crises. Different countries and regions have established different special review channels based on their medical needs and regulatory systems.