Pharmaceutical manufacturers would be given a 24-hour deadline to recall problem drugs that could cause serious harm to takers in a draft plan on China's drug safety.
The State Food and Drug Administration (SFDA) published a draft on drug recall on Thursday to solicit public feedback.
It classified the problem drugs that must be recalled into three categories, with the first being potentially fatal and harmful drugs, which must be recalled in 24 hours.
The second category was drugs that may cause temporary health problems and producers had three days to recall these.
The third category was drugs that must be recalled within seven days for other reasons such as improper packaging.
The plan requires manufacturers to promptly analyse information and feedback from hospitals, retailers and users, and to investigate and evaluate potentially unsafe drugs.
If a potential danger is confirmed, the makers must recall the product, inform retailers, users and the public of the possible effects.
The draft allows the government to revoke the manufacturing license if the drugs cause serious harm or the makers fail to recall the drugs or inform the pubic promptly.
If retailers and hospitals find problems, they must immediately stop selling and using the product, inform the makers and providers, and submit a timely report to the quality supervision authorities.
If they fail to do so, they face fines ranging from 1,000 (132 U.S. dollars) to 50,000 yuan or revocation of licenses in serious cases.
On Sept. 16, the Shanghai municipal government ordered Shanghai Hualian Pharmaceutical Co. to recall leukemia drugs methotrexate and cytarabine hydrochloride after they had caused adverse reactions, including difficulty in walking and retention of urine, in some patients.
The government has tried to strengthen supervision of pharmaceutical and biological products this year. In July, the SFDA revoked the production license of Guangdong Baiyi Pharmaceutical Company for making blood products from a donor infected with hepatitis C.
The State Food and Drug Administration (SFDA) published a draft on drug recall on Thursday to solicit public feedback.
It classified the problem drugs that must be recalled into three categories, with the first being potentially fatal and harmful drugs, which must be recalled in 24 hours.
The second category was drugs that may cause temporary health problems and producers had three days to recall these.
The third category was drugs that must be recalled within seven days for other reasons such as improper packaging.
The plan requires manufacturers to promptly analyse information and feedback from hospitals, retailers and users, and to investigate and evaluate potentially unsafe drugs.
If a potential danger is confirmed, the makers must recall the product, inform retailers, users and the public of the possible effects.
The draft allows the government to revoke the manufacturing license if the drugs cause serious harm or the makers fail to recall the drugs or inform the pubic promptly.
If retailers and hospitals find problems, they must immediately stop selling and using the product, inform the makers and providers, and submit a timely report to the quality supervision authorities.
If they fail to do so, they face fines ranging from 1,000 (132 U.S. dollars) to 50,000 yuan or revocation of licenses in serious cases.
On Sept. 16, the Shanghai municipal government ordered Shanghai Hualian Pharmaceutical Co. to recall leukemia drugs methotrexate and cytarabine hydrochloride after they had caused adverse reactions, including difficulty in walking and retention of urine, in some patients.
The government has tried to strengthen supervision of pharmaceutical and biological products this year. In July, the SFDA revoked the production license of Guangdong Baiyi Pharmaceutical Company for making blood products from a donor infected with hepatitis C.
Related News
Photos
More>>
trade
- Workers were building Waiting Pavilions in the dock of black awning boats in
- Celebration of the 2500th anniversary of the founding of Shaoxing and Press
- Candidates of World Choir Games' Volunteers started training
- Shaoxing Luxun Primary School held World Choir Games and Me activity
- The Choir from the Philippines will Sing with the Bamboo Flutes