help: do we need to carry out clinic trials in Singapore?

[Lilijiang]

angry

[ksl]

do anyone in the field of medicine help me? I work for a Chinese pharmaceutical Company. The drug is a new chemical entity. We have carried out the clinical trials in China. At present, the drug has been approved and evulated by SFDA of China. If we want to register this drug in Singapore, do u need to carry out clinical trials in Singapore? That is to say, does singapore HSA accept the clinical trials carried out in China?
My e-mail is redap1126@hotmail.com.

Not very likely!!! Check with the Ministry

[ksl]

do anyone in the field of medicine help me? I work for a Chinese pharmaceutical Company. The drug is a new chemical entity. We have carried out the clinical trials in China. At present, the drug has been approved and evulated by SFDA of China. If we want to register this drug in Singapore, do u need to carry out clinical trials in Singapore? That is to say, does singapore HSA accept the clinical trials carried out in China?
My e-mail is redap1126@hotmail.com.

Not very likely!!!

[ksl]

do anyone in the field of medicine help me? I work for a Chinese pharmaceutical Company. The drug is a new chemical entity. We have carried out the clinical trials in China. At present, the drug has been approved and evulated by SFDA of China. If we want to register this drug in Singapore, do u need to carry out clinical trials in Singapore? That is to say, does singapore HSA accept the clinical trials carried out in China?
My e-mail is redap1126@hotmail.com.

Not very likely!!! check with the ministry

[BleepBleep]

It depends on what are the claims for your chemical, if it is for the treatment of diseases or medical conditions, rather than a health supplement, you will need to register with HSA. HSA tends to approve drugs or chemical entities which already are approved in the US or reference Europe countries like Switzerland and Germany. Running clinical trials in Singapore or China alone without the international approvals may not get you HSA approval.

This website should give you more information. http://www.hsa.gov.sg/html/business/eforms.html

[Vaucluse]

No problems at all - there are no independant medical authorities here - we are all guinea pigs for the extremely professional medical research industry in China that needs to ask questions like this on open forums . . .


We all trust you!!!!