The National Health and Medical Commission publicly solicits opinions on the "Working Plan for the Temporary Import of Drugs Urgently Needed in Clinical Practice"

Second, the scope of drugs

It is suitable for a small amount of clinically urgently needed medicines that have not been registered in China, have not been produced by enterprises or cannot be resumed in a short period of time
.
Among them, a small amount of drugs urgently needed in clinical practice are drugs that meet one of the following conditions:

(1) Medicines for the treatment of rare diseases;

(2) Medicines for the prevention and treatment of serious life-threatening diseases for which there is no effective means of treatment or prevention;

(3) Medicines for the prevention and treatment of serious life-threatening diseases with obvious clinical advantages
.

3.
Application Workflow

(1) A medical institution shall submit a temporary import application to the State Food and Drug Administration or the people's government of a province, autonomous region or municipality directly under the Central Government authorized by the State Council, and provide the following materials as required:

1.
A copy of the legal registration document of the medical institution (such as the medical institution practice license, business license (if any), organization code certificate, etc.
)
.

2.
Application report and letter of commitment
.
The content should include: the specific use of the drug to be imported, the necessity of import, the name, address and contact information of the medical institution applying for it
.
The medical institution promises in writing that the drugs to be imported will be used for specific medical purposes in the designated medical institution, and shall not be used for purposes other than the application for use
.

3.
List of drugs to be imported
.
The content should include: drug name, dosage form, specification, import quantity, name and address of the overseas holder, name and address of the manufacturer, place of origin of the drug, and the name of the port to be declared for customs clearance
.

The above materials must be stamped with the official seal of the medical institution
.

(2) After receiving an application from a medical institution, the State Food and Drug Administration may seek the opinion of the National Health and Health Commission on whether the applying medical institution has the ability to use and manage the drug, whether the drug is urgently needed clinically, and whether the demand for the drug is reasonable
.
The National Health and Health Commission may, as the case may be, solicit the opinions of the provincial health and health authorities where the medical institution is located
.
Within 3 working days after receiving the written feedback from the National Health and Health Commission, the State Food and Drug Administration shall, for the applications that meet the requirements, issue a reply letter of approval to import in the form of a comprehensive department letter of the Bureau, and send a copy of the reply to the National Health and Health Commission, each department.
Provincial-level drug supervision and administration departments, port drug supervision and administration departments, and the National Health and Health Commission send copies to all provincial-level health and health authorities
.

(3) The medical institution shall apply to the port drug supervision and administration department for the "Imported Drug Customs Clearance Form" according to the reply letter
.
Such imported drugs do not need to undergo port inspection
.

(4) If the imported drugs are narcotic drugs and psychotropic drugs within the scope of state regulations, it is also necessary to apply to the State Food and Drug Administration for an import license
.
A medical institution may entrust an import unit to apply for an import permit
.
The importing unit shall submit the application in accordance with the guidelines for the approval of the import of narcotic drugs and psychotropic drugs for clinical use published by the online office of the State Food and Drug Administration
.

Specific materials include: application form for the import of narcotic (psychoactive) drugs; copies of purchase contracts or orders; copies of entrustment agency agreements for medical institutions; copies of the importer's "Business License" and "Foreign Trade Operator Filing and Registration Form"; If it is the sales agency company of the drug, it is also necessary to provide the agency agreement and the legal qualification certification documents of the exporting unit, notarized texts and certified texts; the self-assurance statement of the authenticity of the application materials
.
If the regulations are met, the State Food and Drug Administration will issue an import license within 3 working days
.

The application can be submitted simultaneously with (1) the application for temporary import by a medical institution, and the State Food and Drug Administration will approve it at the same time
.
If the applicant is unable to submit the application materials at the same time due to his own reasons, he may also submit (1) and (4) applications separately
.

(5) Those importing narcotic drugs and psychotropic drugs within the scope prescribed by the state shall go through customs declaration, inspection and release procedures with the import permit
.

(6) If the imported drugs are for the treatment of rare diseases, in principle, a medical institution of the National Rare Disease Diagnosis and Treatment Collaboration Network will serve as the lead import institution to compile the list of medical institutions nationwide and the medical institutions that use the drug, and follow this document.
The plan calls for taking the lead in filing temporary import applications and organizing the use and management work
.

4.
Drug use management

Medical institutions that use temporarily imported drugs shall, in accordance with the Regulations on the Administration of Pharmaceutical Affairs of Medical Institutions, focus on the following tasks:

(1) Formulate clinical technical specifications, clarify the clinical diagnosis and treatment use of drugs, patient groups, departments and doctors list; establish a special management system, review the suitability of physicians' prescriptions and medication orders, and strictly regulate physicians' drug use behavior
.

(2) Monitor and record the clinical diagnosis and treatment records, drug safety, efficacy, price, compliance, adverse reactions and other information data related to the use of temporarily imported drugs, and should be kept for a long time
.
In the event of serious adverse reactions, promptly notify the drug supervision and administration department, health authority, and domestic drug business enterprise of the province where the medical institution is located
.
Provincial drug supervision and administration departments and provincial health and health authorities jointly study and judge the risks of clinical drug use, take emergency control measures such as discontinuation of use if necessary, and report to the higher-level authorities respectively
.

(3) Formulate sound safety precautions and risk monitoring and disposal plans
.

(4) Temporarily imported drugs should be properly stored in accordance with regulations
.

(5) Temporarily imported drugs should be evaluated on an annual basis and reported to the provincial health authority
.

(6) Selecting pharmaceutical business enterprises to carry out relevant work such as purchasing, importing and distributing temporarily imported pharmaceuticals as required
.

(7) For rare disease drugs, in principle, scientific management of drug use shall be strengthened by relying on the "China Rare Disease Diagnosis and Treatment Service Information System" and the National Rare Disease Diagnosis and Treatment Collaboration Network
.

V.
Rights and Responsibilities of Related Parties

Medical institutions and operating enterprises shall bear the risk responsibility for temporarily imported drugs in accordance with the law
.
The medical institution shall sign an agreement with the operating enterprise, and the operating enterprise shall sign an agreement with the overseas manufacturing enterprise, clarifying the responsibilities of both parties and ensuring the quality of the drugs
.

Formulate relevant provisions on liability risk sharing and liability exemption
.
Before taking medication, the doctor should clearly explain the condition, medication risks and other matters that need to be informed to the patient, and obtain written informed consent; if it is impossible or inappropriate to explain to the patient, the doctor should explain to the patient's close relatives and obtain their written informed consent
.

6.
The people's governments of provinces, autonomous regions and municipalities directly under the Central Government authorized by the State Council may formulate corresponding work procedures and requirements with reference to this work plan and their own actual work conditions
.

Annex 2

Temporary import work programme for clobazam

(Draft for comments)

In order to meet the urgent need for clinical use of clobazam, a work plan for the temporary import of clobazam was formulated in accordance with the relevant provisions of the "Work Plan for Temporary Import of Drugs in Urgent Clinical Needs"
.

1.
Application Workflow

(1) The National Health and Health Commission organizes the clinical demand for clobazam, determines the list of medical institutions that use it, selects the medical institution to lead the import, organizes the formulation of drug use specifications and prescription qualification requirements, and specifies the requirements for informed consent of patients and exemption of doctors from liability
.

(2) The medical institution leading the import shall file a temporary import application with the State Food and Drug Administration, and provide the following materials as required:

1.
A copy of the legal registration document of the medical institution (such as the medical institution practice license, business license (if any), organization code certificate, etc.
)
.

2.
Application report and letter of commitment
.
The content should include: the name, address and contact information of the medical institution applying for
.
The medical institution promises in writing that the drugs to be imported will be used for specific medical purposes in the designated medical institution, and shall not be used for purposes other than the application for use
.

3.
List of drugs to be imported
.
The content should include: drug name, dosage form, specification, import quantity, name and address of the overseas holder, name and address of the manufacturer, place of origin of the drug, and the name of the port to be declared for customs clearance
.

The above materials must be stamped with the official seal of the medical institution
.

At the same time, the medical institution leading the import may entrust the import unit to apply for the import permit
.
The importing unit shall submit an application for an import license in accordance with the guidelines for the approval of the import of narcotic drugs and psychotropic drugs for clinical use published by the online office of the State Food and Drug Administration.
The specific materials include:

4.
Psychotropic drug import application form
.

5.
A copy of the purchase contract or order
.

6.
A copy of the agency agreement of the medical institution
.

7.
Copies of the "Business License" and "Foreign Trade Operator Recording and Registration Form" of the importing unit
.

8.
If the exporter is the sales agency of the drug, it is also required to provide the agency agreement and the legal qualification certificate, notarized text and certified text of the exporter
.

9.
Self-assurance statement of the authenticity of the application materials
.

The above-mentioned materials 1-9 can be submitted simultaneously.
If the applicant cannot submit simultaneously due to its own reasons, parts 1-3 and 4-9 can also be submitted separately
.

(3) After the State Food and Drug Administration receives the relevant application from the medical institution, if it meets the requirements, it will issue a reply letter of approval to import in the form of a comprehensive department letter of the Bureau within 3 working days, and the reply letter will be copied to the National Health and Health Commission and the provinces.
The drug supervision and management department at the level and the port drug supervision and management department, and the National Health and Health Commission will send a copy to the provincial health and health authorities
.
At the same time, an import permit is issued
.

(4) The importing unit shall go through the customs clearance formalities directly with the customs with the import permit
.
Such imported drugs do not need to undergo port inspection
.

2.
Drug use management

Medical institutions that use temporarily imported drugs shall, in accordance with the Regulations on the Administration of Pharmaceutical Affairs of Medical Institutions, focus on the following tasks:

(1) Formulate clinical technical specifications, clarify the clinical diagnosis and treatment use of drugs, patient groups, departments and doctors list; establish a special management system, review the suitability of physicians' prescriptions and medication orders, and strictly regulate physicians' drug use behavior
.

(2) Monitor and record the clinical diagnosis and treatment records, drug safety, efficacy, price, compliance, adverse reactions and other information data related to the use of temporarily imported drugs, and should be kept for a long time
.
In the event of serious adverse reactions, timely report to the drug supervision and administration department of the province where the medical institution is located, the competent health department, and domestic drug dealers
.
Provincial drug supervision and administration departments and provincial health and health authorities jointly study and judge the risks of clinical drug use, take emergency control measures such as discontinuation of use if necessary, and report to the higher-level authorities respectively
.

(3) Formulate sound safety precautions and risk monitoring and disposal plans
.

(4) Temporarily imported drugs should be properly stored in accordance with regulations
.

(5) Temporarily imported drugs should be evaluated on an annual basis and reported to the provincial health authority
.

(6) Selecting pharmaceutical business enterprises to carry out relevant work such as purchasing, importing and distributing temporarily imported pharmaceuticals as required
.

(7) Relying on the "China Rare Disease Diagnosis and Treatment Service Information System" and the National Rare Disease Diagnosis and Treatment Collaborative Network to strengthen the scientific management of drug use
.

3.
Qualifications and management requirements of prescribing physicians

(1) Engaged in the diagnosis and treatment of epilepsy or childhood epilepsy for more than 10 years, as a deputy chief physician or chief physician;

(2) Possess the right to prescribe narcotic drugs and psychotropic drugs;

(3) Have clinical experience in using benzodiazepines to treat epilepsy;

(4) Be able to strictly grasp the indications of clobazam (limited to epilepsy);

(5) Familiar with the usage and dosage of clobazam, evaluation of therapeutic effect, monitoring and treatment of adverse reactions;

(6) In accordance with the current requirements for the use of benzodiazepines in their respective hospitals, and each prescription should not exceed a maximum of 1 month's consumption
.

4.
Rights and Responsibilities of Related Parties

The leading medical institutions and operating enterprises shall bear the risk responsibility for the temporarily imported drugs in accordance with the law
.
The medical institution shall sign an agreement with the operating enterprise, and the operating enterprise shall sign an agreement with the overseas manufacturing enterprise, clarifying the responsibilities of both parties and ensuring the quality of the drugs
.

Formulate relevant provisions on liability risk sharing and liability exemption
.
Before taking medication, the doctor should clearly explain the condition, medication risks and other matters that need to be informed to the patient, and obtain written informed consent; if it is impossible or inappropriate to explain to the patient, the doctor should explain to the patient's close relatives and obtain their written informed consent
.