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| Name: |
SFDA statements on drug donations |
| Type： |
Other |
Issuing
Agency ： |
SFDA |
| Categories： |
Marketing,Sales and Distribution |
Effective
Date: |
n/a |
Withdraw/
Expiry Date: |
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| Summary： |
Yan Jiangying, Spokeswoman of SFDA, clarified about China's rules on drug donations at the agency's press conference on Feb. 1, 2008.
She made following statements about drug donation in China in accordance with the Drug Administration Law and relevant SFDA regulations.
- Donations of hospital formulations, foreign-made drug products and medical devices not approved by foreign governments, drug products approved only for clinical trials or trial production, foreign-made biological products are banned from donations, and drug products manufactured in accordance with local drug standards are banned;
- Donations of fake, substandard, counterfeit or expired drug products and medical devices will be severely punished;
- Donated drug products and medical devices must have at least six months of validity; and they should only be donated to provincial level and above civil administrations, health administrative departments, China Red Cross Society and China Charity Federation and its provincial and above level branches. Such donated products are banned for sale.
- Domestically-produced drugs products with SFDA approval for production and meeting relevant quality standards can be donated, but sampling and examination reports from provincial level institute for control of drugs are required.
- Drugs produced abroad which are listed in the Chinese national drug standards or internationally-acceptable pharmacopoeias, or approved for import, and are legally manufactured meeting quality standards of the origin country can be donated in China. Donors must submit to the SFDA their lists of donations with quality standards and package inserts attached. Donated drugs will be subjected to inspection and examinations by the destination port institutes for control of drugs.
- Donation of foreign-made drug products must be approved by the SFDA which will issue drug import permits, and must follow relevant importation procedures with the permits. |
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