Shanghai Issued Regulations on Biomedicine Industry

The Standing Committee of the Fifteenth Shanghai Municipal People's Congress passed the "Regulations of Shanghai Pudong New Area on Promoting the Construction of Zhangjiang Biomedicine Industry Innovation Highland"(“Regulations”).

The highlights of the Regulations are as follow:

1. Within the scope of national authorization, the government can approve the import of small amount of medicines and medical devices that are urgently needed for clinical use by qualified medical institutions in Pudong New Area. Imported medicines and medical devices shall be used for specific medical purposes in designated medical institutions.

2. Under the premise of controllable risks, the government will support qualified diversified investment entities to carry out research and development of human cell and gene technology and promote the process of industrialization.

3. For biomedical companies in the Pudong New Area within the scope permitted by the relevant state departments, they can explore the implementation of bonded supervision of the goods (including materials, consumables, reagents, etc.) required for their cross-border research and development.

4. The holder of the drug marketing license in Pudong New Area can produce the drug on its own or entrust the production of the drug to a drug manufacturer in accordance with the law. After being approved by the national drug regulatory authority, the holder of the drug marketing license in Pudong New Area may entrust the production by more than one qualified drug manufacturer within the city. However, the production of blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, and pharmaceutical precursor chemicals shall not be commissioned, unless otherwise approved by the national drug regulatory authority.

5. When applying for a drug production license in the clinical trial phase of a drug, the municipal drug regulatory authority may issue a "Drug Production License" under the circumstance that the production conditions of the clinical samples are consistent with the production conditions in the marketing license application phase.