1. If applying for carrying out drug clinical trials, manufacturing and importation in China, what rules need to abide?

According to Drug Registration Regulation concretely disclosed at http://www.sda.gov.cn/WS01/CL0053/24529.html, an applicant should submit a registration application to State Food and Drug Administration (SFDA) or provincial food and drug administrations.

2. Who can be drug registration applicants?
A drug registration applicant (applicant) means an institution that makes drug application and assumes corresponding liability for drug registration. A local applicant shall be a legally registered institution in China and be competent to independently assume legal liability. A foreign applicant shall be a legally established pharmaceutical company outside of China. In making application for an imported drug registration, the foreign applicant shall use its office in China, or authorize an agent in China to handle the application. The person(s) handling the drug registration application shall have technical expertise, and be familiar with drug administration laws, regulations and technical requirements.

3. How to submit drug registration applications in China?
Drug registration application includes application for new drug, generic drug applications, application for imported drug, supplemental application, as well as re-registration application.
A new drug application means a registration application for a drug that has not been marketed in China. Applications made for a change in dosage form, or route of administration, additional new indication of drugs shall be made according to new drug registration procedure.
Generic drug application means application for registration of a drug for which SFDA has already issued formal standards, however, application of biological products shall be follow new drug application.
Application for imported drug means application for a drug produced outside China to be marketed in China.
Supplemental application means an application for the change, addition, or cancellation of any item or contents in the existing registration approval of a new drug, generic drug applications, or imported drug.
A re-registration application means the application to continue the drug production or importation after the expiry of the certified drug approval documents.

4. To which department should the drug registration application be submitted?
Applications for new clinical study, production of new drug, generic drug, repackaging of imported drug, as well as drug re-registration should be submitted to local provincial food and drug administrations .
Applications for the registration and the re-registration of imported drugs should be submitted to SFDA.
If two or more institutions jointly apply for drug registration, the application shall be made to provincial food and drug administrations where the drug manufacturer is located. If all the applicants are manufacturers, the application shall be made to provincial food and drug administrations where the drug manufacturer of the preparation is located. If none of the applicants is a drug manufacturer, the application shall be made to provincial fooe and drug administrations where the drug sample is pilot manufactured.

5. What is the pre-clinical laboratory study (pre-clinical study) of a drug?
The scope of pre-clinical laboratory study (pre-clinical study) of a drug for registration includes synthetic process, extraction methods, physical-chemical properties and purity, dosage form selection, screening of formulas, preparation process, inspection methods, quality specification, stability, pharmacology, toxicology and pharmacokinetic study. For Traditional Chinese Medicine(TCM) preparations, information such as the source and the processing of raw materials should also be included. For biological products, information such as source, quality standards, storage condition, biological identity, genetic stability and immunology study of strain, cell strain as well as biological tissue should also be included.

6. How is the clinical study of new drugs performed?
Clinical study of drugs must be approved by SFDA, and must be conducted in accordance with Good Clinical Practice (GCP).
Clinical trials are divided into Phase I, Phase II, Phase III and Phase IV.

7. Where the clinical study of new drugs is conducted?
After approval of a clinical study, the applicant shall select from the institutions qualified for drug clinical trial to conduct the clinical study. The investigational drugs shall be produced in a workshop which meets GMP requirements and the production process shall be strictly in accordance with the requirements of GMP. The applicant is responsible for the drug quality of the investigational drugs.

8. Before the clinical study, do drugs need to be tested?
The applicant may inspect the investigational drug itself in accordance with the drug's standards for its selected drugs for clinical trial, or authorize a drug control institute designated by this Regulation to conduct the quality test. Vaccine, blood products and other bio-products designated by SFDA must be inspected by a drug control institute designated by SFDA. The drug must not be used for Clinical Trails before it has passed the inspection. Drug administration authorities may conduct a random inspection for the investigational drug.

9. Before conducting the clinical study, does the clinical study need to be filed?
Before conducting the clinical study, the applicant shall file with SFDA information such as the clinical study protocol, name of the principle investigator of the leading institution, participating institutions and investigators, approval letter from ethics committee, and the sample of the Informed Consent Form, also providing a copy to provincial food and drug administrations where the institutions are located and provincial food and drug administrations where the application was filed.

10. Does the approval certificate for a clinical study have time limit?
A clinical study shall start within 3 years of approval. Otherwise the approval certificate shall automatically become null and void. A re-application shall be submitted to resume the study.

11. Does a foreign applicant who wants to conduct an international multi¨Ccenter clinical study need to apply?
A foreign applicant who wants to conduct an international multi¨Ccenter clinical study shall apply at SFDA in accordance with Drug Registration Regulation and follow the relevant provisions.

12. Is there special approval for drug registration?
SFDA may use special approval process for the following new drug, where detail regulation will be promulgated separately:
a) New drug material and its preparation, active ingredients and its preparation extracted from plant, animal and minerals, which have not been marketed in China and;
b) chemical drug raw material and its preparations, and/or biological product that have not been marketed domestically or outside China;
c) new drugs for AIDS, cancer and orphan disease that are superior to the marketed drugs.
d) new drugs which treat diseases for which there is no effective therapy.
For those drugs meeting the above provisions of this Regulation, during the drug registration, the applicant may apply for a special approval, SFDA shall organize specialist meeting to decide whether to use special approval for the drug application.

13. How the application for a new drug jointly developed by a plurality of parties be conducted?
When a new drug is jointly developed, the application shall be made by one of the parties, and other parties shall not apply in repetition. When a joint application needs to be made, the application shall be signed by all the parties. After approval, all the new drugs, including different strengths of the same drugs shall only be manufactured by one party.

14. Who can be an applicant of generic drug?
Applicant of generic drug should be a drug manufacturer. The drug for which application is made shall be consistent with the production scope described in Drugs Manufacturing License.
15. What are the requirements on drugs under import application?
The drugs under import application should have obtained marketing approval in its country/region of manufacture. Without such a marketing approval, a drug to be imported may still be approved if SFDA confirms the safety and efficacy of the kind of drug, and if there is a clinical need for the drug. The production of drugs under import application should meet the GMP standard in the foreign country / region as well as the requirements of GMP in China.

16. What is the repackaging of imported drugs?
Repackaging of imported drugs means taking from offshore finished drug preparation in large packaging and putting them into smaller packaging, or taking drugs in smaller packaging and placing them into final (outside) packaging with an insert sheet, labeling, etc. in China.

17. What are the requirements on the application for repackaging of imported drugs?
The application for repackaging of imported drug shall comply with following requirements:
a) an Imported Drug Certificate or Pharmaceutical Product Certificate has already been obtained for the imported drugs;
b) the drugs are not yet to be manufactured in China or, if manufactured, not able to meet the clinical demand;
c) the drugs of one pharmaceutical company shall only be repackaged by one pharmaceutical production enterprise, generally for a period not exceeding the valid period of Imported Drug Certificate or Pharmaceutical Product Certificate.
d) With exception of tablet or capsule, internal packing of repacked drugs in all other dosage form should be finished offshore;
e) the pharmaceutical production enterprise to accept repacking should hold a Drug Manufacturing License. When imported uncoated tablet or capsule are to be repacked, enterprise to accept repacking should also hold a GMP Certificate consistent to the dosage form of the drug to be repacked.
f) Any application for repacking of imported drug should be made one year prior to expiration of Imported Drug Certificate or Pharmaceutical Product Certificate.

18. Who should apply for the repackaging of imported drugs?
The offshore pharmaceutical company shall sign a repackaging contract for imported drugs with an onshore pharmaceutical production enterprise. An application for repackaging a drug shall be submitted by the onshore pharmaceutical production enterprise to provincial food and drug administrations where the party is located, and the Drug Supplemental Application Form signed by the offshore pharmaceutical company should be submitted with the relevant information and sample products.

19. What situation should the re-registration of drugs be conducted?
The validity period of the Drug Approval Number, the Imported Drug Certificate and Pharmaceutical Product Certificate issued by SFDA is 5 years. 6 months prior to the expiration, application for re-registration shall be made, should there be a need for continuing the production and / or importation.

20. How drugs are classified in China?
In China, drugs are divided into traditional Chinese medicine and natural drugs, chemicals and biological products, wherein biological products are divided into therapeutic biological products and preventive biological products. Documents required by the registration application items for different types of drugs are different. For details, please see http://www.sda.gov.cn/WS01/CL0053/24529_9.html

 

1. What is the application process for new drugs ( clinical trials or the clinical production)?

2. What is the application process for generic drugs?

 

3. What is the application process for imported drugs?

 

4. What is the application process for the repackaging of imported drugs?

 

5. What is the application process for the re-registration of drugs?