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Registration services
 Imported drugs
registration
Imported medical
devices
registration
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The required documentation for the
imported drugs registration in China.
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1)
Name of the drugs.
2) Certified Documents.
3) Objectives and basis for R & D.
4) Summary of main study work.
5) Draft of packaging insert, note to the draft, and
latest literature.
6) Design of packaging and labeling.
7) Summary of Pharmaceutical Study.
8) Research information and relevant literature of
the production process of the drug substance,
research information and relevant literature of
formula and process of the preparations.
9) Study information and relevant literature for the
chemical structure and components determination.
10) Study information and literature for quality
specification.
11) Draft of quality specification and notes, and
providing reference standard.
12) Test report of drug sample.
13) The source, test report and quality
specification of drug substance and excipient.
14) Stability study and relevant literature.
15) Selection basis and quality specification of
immediate packing material and container.
16) Summary of pharmacology and toxicology study.
17) Study and literatures of primary
pharmacodynamics.
18) Study and literatures of general pharmacology.
19) Study and literatures of acute/single dose
toxicity.
20) Study and literatures of repeated dose toxicity.
21) Special safety study and literatures of
hypersensitive (topical, systemic and
photo-toxicity), hemolytic and topical irritative
(blood vessel, skin, mucous membrane, and muscle)
reaction related to topical and systemic use of the
drugs.
22) Study and literatures on pharmacodynamics,
toxicity and pharmacokinetic change caused by the
interactions amongst multiple components in the
combination products.
23) Study and literatures of mutagenicity test.
24) Study and literatures of reproductive toxicity.
25) Study and literatures of carcinogenicity test.
26) Study and literatures of drug dependence.
27) Study and literatures of pre-clinical
pharmacokinetics.
28) Summary of global clinical study information.
29) Clinical study protocol.
30) Investigator¡¯s Brochure.
31) Draft of Informed Consent Form, approval of the
Ethics Committee.
32) Clinical study report.
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Contact
Tel: 86-10-68180921
Mobil phone: 13911611675, 13501010127
Fax£º86-10-68187090
E-mail£ºzhuoliyang@gmail.com
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The other related
documentation is attached as following:
The procedure of imported drugs registration.
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