Requirements for Registration documents of Veterinary Biological Products
( Decree of the Ministry of Agriculture of the People’s Republic of China No.442)
 
Application Documents and Requirements for Imported Preventive Biological Products
(A) Application Documents for Imported Preventive Biological Products
1. General Documents
(1)   Names of biological products;
(2)     Certificate documents:
a. Registration license of enterprise, product license, certificate of free sale, certificate of GMP. These documents shall be notarized by a notary public of the country where the enterprise is located and confirmed by the Chinese embassy or consulate stationed there;
b. If an application is made by a resident representative office in China of an overseas pharmaceutical manufacturer, a photocopy of “Registration Certificate of Resident Representative office in China of Foreign Enterprise” shall be submitted;
c. If an application is made by an agency in China, which is authorized by an overseas pharmaceutical manufacturer, photocopies of any power of attorney, notarial deed and their Chinese versions and the “Business Licence” of the agency in China shall be submitted;
d. Description of the biological products under application and their formulas, processes and other patent conditions and title status and a letter of guarantee that no infringement shall be caused to any patent of a third party;
e. Registration in the other country and license number.
(3)     Outline of Production, Control test on the finished product, attaching SOP for major items of test;
(4)     Instruction for use, label and packing design.
2.        Study documents on bacterial (or viral or verminous) strains used for production:
a. Code, source, passage history, serology identity and specificity for the seed.
b. Passage method, quality, passage level, preparation, storage of the master seed.
c. Identity test report of the working seed.
3.        Study documents on virulent strains for control test;
4.        Study documents on Cellular Matrixes used for Production;
5.        Study documents on major raw (auxiliary) materials, If it involves any bovine substances, appropriate information shall be provided in accordance with the relevant provisions of the state;
6.        Study documents on Production Technology;
7.        Study documents on Product Quality:
a. Safety: for no-target animal and no-usage age; horizontal spread test; one dose test by each vaccination route; single dose by re-inoculate; safety study for pregnancy animal; effect to immune function etc.
b. Potency: three batches test report; correlation study between the titre and result of challenge protect; correlation study between the serology efficacy test and result of challenge protect.
c: Duration of immunity report.
d. Efficacy and immunity period test for passive protection of newborns from vaccinated breeders.
e. Eat and flow of antibody in the body study after vaccination.
e. Vaccination procedure study.
f. Stability test.
8.        production and control test report of at least three serial batches of product;
9.        Study documents on field test: efficacy and safety report
Note:
1. All the test data in the application dossier submitted shall be test obtained in out of China. Any kind of test can not be conducted in the territory of China without permission;
2. All the application documents shall be translated into Chinese and enclosed with the original language and the Chinese versions shall be fully corresponding to the contents of the originals. If the original language is not English, it shall first be translated into English, and the original language, English translation should be enclosed for reference;