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Announcement of the State Food and Drug Administration on Issuing the registration fees for the registration of drugs and medical devices
Announcement of the State Food and Drug Administration on Issuing the registration fees for the registration of drugs and medical devices
     According to the Ministry of finance, national development and Reform Commission on the re release of the central management of food and drug supervision and management departments of administrative fees and charges, and on the issuance of "drug, medical device registration fee standard management approach" (1006), the State Food and Drug Administration (2015), the State Food and Drug Administration formulated the "drug, medical device registration fee standards (Trial)" and "medical device registration fees and implementation details (Trial)", is released, from the date of implementation.

Notice.

Annex: 1 drug, medical device registration fees

2 implementation details of drug registration fees (for Trial Implementation)

3 implementation details of the registration of medical device products (for Trial Implementation)

Food and Drug Administration

May 27, 2015



 

附件1

Drug, medical device registration fees

Drug registration fee

The Department of food and drug administration under the State Council and the provincial food and drug supervision and management departments shall, in accordance with the statutory duties, apply for new drug clinical trials, manufacture applications, copy pharmaceutical applications, supplementary applications and re registration applications for the administrative acceptance, on-site inspection / verification, technical review, etc.. Specific charges are as follows:

药品注册费标准

 

 

 

 

单位:万元

 项目分类

 国产

 进口

新药注册费

临床试验

19.20

37.60

生产/上市

43.20

59.39

仿制药注册费

无需临床试验的生产/上市

18.36

36.76

需临床试验的生产/上市

31.80

50.20

补充申请注册费

常规项

0.96

0.96

需技术审评的

9.96

28.36

药品再注册费(五年一次)

由省级价格、

财政部门制定

22.72

 Note: 1. The drug registration fees according to a drug substance or a preparation for a variety of instalments, such as additional specifications, according to the types of the corresponding income 20% registration fee. 2. The measures for the administration of drug registration, belongs to the provincial food and drug supervision and management departments for the record or the State Food and drug supervision and administration department directly for the record of the supplementary drug application matters, do not charge additional registration fee, so applications audited that apply to technical review, the applicant should be in accordance with the needs of the technical review of the supplementary application fees pay the costs. 2000 to apply for a one-time import of drugs, drug registration fee charged 3 yuan. 4. The drug import registration fees in domestic relevant registration fee standards on the basis of additional domestic and international traffic inspection fees, accommodation and meals and difference. 5 Hong Kong, Macao and Taiwan drug registration fees charged by the registration of imported drug registration fees.

6 drug registration fees shall be separately formulated urgent.






Two, medical device registration fee

The food and drug supervision and administration department under the State Council and the provincial food and drug supervision and management departments shall, in accordance with the statutory functions, register and change the registration, change registration, registration of third kinds of medical device products for the first time, and apply for third kinds of high risk medical devices. Specific charges are as follows:

医疗器械产品注册费标准

 

 


单位:万元

项目分类

境内

进口

第二类

首次注册费

由省级价格、

财政部门制定

21.09

变更注册费

由省级价格、

财政部门制定

4.20

延续注册费(五年一次)

由省级价格、

财政部门制定

4.08

第三类

首次注册费

15.36

30.88

变更注册费

5.04

5.04

延续注册费(五年一次)

4.08

4.08

临床试验申请费(高风险医疗器械)

4.32

4.32

Note: 1. The medical devices registration fees according to the medical device registration management approach ", the" in vitro diagnostic reagents registration management measures "to determine the registration unit of 2003. 2 "medical device registration management approach," the "in vitro diagnostic reagent registration management approach" is a record of the registration matters change application, not to charge for the change of registration application fee. 3. The imported medical instruments first registration fees in the territory of the corresponding registration fee standards on the basis of additional domestic and overseas traffic inspection fee, accommodation and meals and difference.

4 Hong Kong, Macao and Taiwan medical equipment products registration fees charged by the standard of registration of medical equipment registration fees.

5 medical device registration fees shall be separately formulated urgent.

                                                       

 

附件2

Rules for the implementation of drug registration fees

(Trial)

According to the "drug registration management approach", "on the re release of the central management of food and drug supervision and Administration Department of the administrative fees and charges," and "on the issuance of" drug, medical device registration fee standard management approach, "and other relevant provisions, the formulation of the implementation details.

A drug registration fee payment procedure

(a) new drug registration application

1 domestic drugs. Registration of the applicant to the provincial food and drug supervision and management departments of clinical trials or production applications, the provincial food and drug supervision and administration department issued a "Notice of payment of the administrative licensing project", the registration of the applicant to pay.

2 reference to the import of new drugs. Registration of the applicant to the State Food and drug supervision and administration of clinical trials (including international multi center clinical trial) or listing application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the registration of the applicant to pay.

    

(two) generic drug registration application

1 domestic drugs. Registration of the applicant to the provincial food and drug supervision and management departments to apply, the provincial food and drug supervision and management department received a notice of payment of the administrative licensing items, the registration of the applicant to pay.

The technical evaluation of the need for clinical trials, the applicant for the registration completed clinical trials, to "drug clinical trial approval, and the relevant materials to the provincial food and drug supervision and management departments to apply for the on-site verification, the administrative licensing items of payment notice issued by the provincial food and drug supervision and management departments, registration to the applicant in accordance with the requirements of supplementary difference (3.18 million - 18.36 million =13.44 million yuan).

2 refer to the imported drugs for generic drugs. Registration of the applicant to the State Food and Drug Administration for the application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the applicant is required to pay.

The technical evaluation of the need for clinical trials, the applicant for the registration completed clinical trials, to the State Food and drug administration proposed listing application, the State Food and drug administration after accepting the case, the court issued the notice on administrative licensing items of payment, the applicant for registration in accordance with the requirements of supplementary difference 50.20 million - 36.76_wan million yuan =13.44 million yuan).

(three) supplementary application for registration

1 domestic drugs. Registration of the applicant to the provincial food and drug supervision and management departments to apply, the provincial food and drug supervision and management department received a notice of payment of the administrative licensing items, the registration of the applicant to pay.

2 imported drugs. Registration of the applicant to the State Food and Drug Administration for the application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the applicant is required to pay.

(four) registration of imported drugs

Registration of the applicant to the State Food and Drug Administration for the application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the applicant is required to pay.

Two, drug registration fee payment instructions

(a) new drug application for the registration of drugs, including the management of drug registration, Annex 1 Chinese medicine, natural medicine, 1-8, Annex 3 chemical medicine registration and classification of 1-5 and Annex 2 biological products 1-15. New drug application in accordance with the reporting of clinical trials and reporting production / listing respectively. To apply for the new drug certificate of the new drug certificate in the reference to apply for new drug production of the charges.

(two) generic drug application for the registration of drugs, including 1 Chinese medicine, natural medicine registration and classification 9 and Annex 2 chemical drug registration classification 6.

(three) the import of drugs in accordance with the reporting clinical trials, reporting and payment of the listed separately, with reference to the registration and administration of drugs, the corresponding registration and classification of drugs and generic drugs charges. International multi center clinical trial application for reference to the relevant standard of import drug clinical trial.

(four) supplementary application (general term), including the registration of drugs in Annex 4 of the drug registration management approach, second, 14 (changing the name of the pharmaceutical manufacturer, the registered address, the packaging specification), 16 (changing foreign packaging plant of the non direct contact), 17, 18 (without technical review).

(five) supplementary applications (subject to technical review), including first, 3, 4, 5, 4, 6, 7, 8, 9, 10, 11, 12 (),,, 13, (15),,,,,,,,,,,,,,,,,,,,,,,,,,,, 14,,,,,,,,, 16,,,,,,,,,,,,,,,,,,,,,, 18.

(six) continue to declare a new drug (including imported drugs) II or phase III clinical trial, in accordance with the "drug registration management approach," Annex 4 of the application for registration of drugs eighteenth (requires technical review) to declare and pay.

(seven) the application for approval of a new drug (including an imported drug) for approval shall be given in accordance with the relevant fees and charges for the application of new drugs for the production or listing of new drugs, which shall be stated in the application form for registration of drugs for other special items in the registration application form.

(eight) when the application for production or listing of new raw materials (including an imported drug) is charged, the applicant shall, in accordance with the relevant fees and charges 50% charges, shall be stated in the application form for registration of drugs for other special matters.

(nine) the applicant shall be stated in the application form for registration of the drug registration application form, in the light of the application of the imported drugs for the generic drugs.

(ten) the applicant shall pay the registration fee in accordance with the requirements of the 5 working days after receipt of the notice of payment of the administrative licensing program.

(eleven) after the acceptance of the application, the applicant shall voluntarily withdraw the application for withdrawal, or if the State Food and drug administration shall make a decision on the approval of the State Food and drug administration, the registered fee shall not be returned. Once again, the application for registration shall be re paid.

Three, small and micro enterprises preferential policies

(a) discount range

In line with the provisions of the State Council, the small and micro enterprises put forward with any of the following circumstances innovative drug registration for and free drug registration fee and innovative drug stage II or III clinical trials of registration fee.

Treatment of AIDS, cancer, and not in the domestic market for sale from plants, animals, minerals and other substances extracted from the active ingredients and their traditional Chinese medicine or natural drug preparation.

The chemical raw materials and preparation thereof, which are not sold at home and abroad, by means of synthesis or semi synthesis.

Treatment of biological products with biological products registered 1 not listed in the domestic and international sales.

Preventive use of biological products for the registration and classification of 1 vaccines not listed at home and abroad.

(two) materials required to be submitted

To comply with the "small and medium enterprises designated standards" (the Ministry of industry and trade letter of 300) of the conditions of the registration of the applicant, the application of small and micro enterprises in charge of preferential policies to the holding units submitted the following materials:

1 "small and micro enterprise charges application form" (see table);

2 copy of the business license of the enterprise;

3 on the last year of the enterprise income tax return (to be confirmed by the tax department) or the last year of the effective statistical table (statistical department issued).

In addition, the registration of domestic drug application for registration in the registration form, select the appropriate category.

Four, other problems

(a) to pay the costs of the problem. Domestic drug registration application is required to pay the costs of the, the applicant to relevant documents to the provincial food and drug supervision and management departments pay the associated costs, conduct the remaining work in accordance with statutory procedures; imported drugs registration payment of expenses, the applicant to relevant documents to the State Food and drug administration administrative matters accepts the service and Complaint Center (hereinafter referred to as accepting and Reporting Center) to pay the related costs, conduct the remaining work in accordance with statutory procedures.

(two) the problem of return. Because of the applicant's reason wrong sink, by the applicant to accept and reporting center is put forward, and submit the relevant materials of the refund application, remittance receipt, the non tax revenue general contributions to the book "; because the applicant wrong sink and materials by the State Food and Drug Administration of drug and cosmetic registration division to accept and report center issued a refund notice, accepting and reporting center and the applicant for the registration of contact and by the applicant for registration submitted refund application, remittance receipt, the non tax revenue general contributions to the book" etc., annually on 4 October or before the end of according to the provisions of the handle refund procedures.

(three) combination products. Combination products to play the main role of the material as the standard, the registration fee charged accordingly.

附表

小型微型企业收费优惠申请表

企业名称:

组织机构代码:

行业类型:

企业类型:

联系人:

联系电话:

企业声明

从业人员(人):

上一纳税年度营业收入(万元):

企业资产总额(万元):

兹郑重声明本企业属    小型企业    微型企业,并保证申报的数据和提交的材料真实有效,如本企业不再符合小型微型企业认定标准,将主动申明。

                                           (公章)

法人代表(签名):                               

初审意见:

初审人员:                                     

核准意见:

审核人员:                                    




 

 

附件3

Rules for the implementation of registration of medical device products

(试行)

On the basis of the "medical device registration management approach" (State Food and drug administration to make fourth), "in vitro diagnostic reagent registration management approach" (State Food and drug administration to make fifth), "on the re release of the central management of food and drug supervision and management departments of administrative fees and charges," and "on the issuance of" drug, medical device registration fee standard management approach, "and other relevant provisions of the implementation details.

One, medical device registration fee payment procedures

(a) first application for registration

Registration of the applicant to the State Food and Drug Administration of the third categories, imports of second categories and third types of medical equipment products for the first time registration application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the registered applicant should be paid according to the requirements.

(two) application for registration of change

Registration of the applicant to the State Food and Drug Administration of the third categories, imports of second categories and third types of medical equipment products licensing change registration application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the registered applicant should be required to pay.

Medical device registration management approach, "in vitro diagnostic reagent registration management approach" in the registration of changes to the matter, do not charge for registration of changes in registration fees.

(three) a continuation of registration

Registration of the applicant to the State Food and Drug Administration of the third categories, imports of second categories and third types of medical equipment products continue to apply for registration, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the registered applicant should be paid according to the requirements.

(four) clinical trial application

Medical device registration applicant to the State Food and Drug Administration for clinical trial application, the State Food and Drug Administration accepted after the issuance of the "administrative licensing project payment notice", the applicant should be required to pay.

The third categories of medical devices to be approved for clinical trials shall be formulated, adjusted and promulgated by the State Food and drug administration.

Two, medical equipment products registration fee payment instructions

(a) a registered applicant shall, in accordance with the registration unit, pay the fee for the registration of the product, and shall, in accordance with the relevant requirements for the split of the registration unit, shall be declared separately.

(two) an application for registration of the first registration of second medical instruments by the registered applicant is confirmed as the third category of medical instruments by technical review, and the registration process is to quit. The applicant for registration according to defined management category re apply for the registration, the need to pay the cost difference.

(three) the registration fees for the in vitro diagnostic reagent for medical device management are applicable to the implementation details.

(four) the applicant shall pay the registration fee in accordance with the requirements of the 5 working days after receipt of the notice of payment of the administrative licensing program.

(five) after the application is accepted, the applicant shall voluntarily withdraw the application for withdrawal, or if the State Food and drug administration shall make a decision on the approval of the State Food and drug administration, the registered fee shall not be returned. Once again, the application for registration shall be re paid.

(six) for the first time in accordance with the third category of medical device products, the technical review is recognized as the first class, the second category of medical device products, the difference between the imported product returns, the domestic product refunded all paid fees.

Three, small and micro enterprises preferential policies

(a) discount range

The innovation of medical equipment products of Small and micro businesses for the first time for registration, the registration fee waived. Innovative medical devices products are reviewed by the State Food and Drug Administration (FDA), the office of innovative medical devices (Trial) (Trial) (food and Drug Administration (2014) 13), the acceptance of innovative medical devices for special approval of the relevant experts and the government website publicity, agreed to enter the special approval procedures for the product.

(two) materials required to be submitted

In accordance with the provisions of the "small and medium enterprises designated standards" (the Ministry of industry and trade letter of 300) of the conditions of the registration of the applicant, the application of small and micro enterprises charging preferential policies to accept and report the following materials:

1 "small and micro enterprise fees and favorable application form" (see Annex 2;

2 copy of the business license of the enterprise;

3 on the last year of the enterprise income tax return (to be confirmed by the tax department) or the last year of the effective statistical table (statistical department issued);

4 by the State Food and Drug Administration of medical equipment technical review center issued a special approval of innovative medical devices for review of the application for review.

Four, other problems

(a) to pay the costs of the problem. To due to import the three types of medical equipment products according to the second class for certified exit procedures for the registration, the applicant again declare to relevant documents to the State Food and drug administration administrative matters accepts the service and Reporting Center (hereinafter referred to as accepting and Reporting Center) repay the balance fee.

(two) the problem of return. Because of the applicant's reason wrong sink, by the applicant to accept and reporting center is put forward, and submit the relevant materials of the refund application, remittance receipt, the non tax revenue general contributions to the book "; because the applicant wrong sink, by the State Food and drug supervision and administration of medical devices registered management division to accept and report center issued a refund notice, accept and reporting contact center and the applicant for the registration, and the registration to the applicant submit refund application, remittance receipt, the non tax revenue general contributions to the book" materials, annually on 4 October or before the end of according to the provisions for refund in military continued.

(three) combination products. Combination products to play the main role of the material as the standard, the registration fee charged accordingly.

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