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Korea DMF (Drug Master File) Fees
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Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
Korea DMF (Drug Master File) Fees
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Some Related Topic Tags
api (active pharmaceutical ingredients), drug master file (dmf), korea, south korea mfds (kfda) medical device approval
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  Post Number #1  
Old 4th January 2018, 08:21 AM
hs0wca

 
 
Total Posts: 4
Please Help! Korea DMF (Drug Master File) Fees

Hi

We are interested in submitting an API DMF to the MFDA for a customer but need to know roughly how much this will cost.

I cant find any information on the website or an email address for queries, only a telephone number and I dont expect them to understand English.

Does anyone have any experience with this that they could provide me with a rough estimate or direct me to where I could find the information?

Thank you in advance

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  Post Number #2  
Old 4th January 2018, 10:56 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,177
Re: Korea DMF (Drug Master File) Fees

You can try -

Ministry of Food and Drug Safety
Republic of Korea Tel: (+82) 43 719-1564
Fax: (+82) 43-719-1550
Email: wtokfda@korea.kr

Also refer an existing thread
Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact?
  Post Number #3  
Old 4th January 2018, 11:01 AM
hs0wca

 
 
Total Posts: 4
Re: Korea DMF (Drug Master File) Fees

Fabulous thank you. I did find find some fee indicators under the regulations section on the web site.

Thanks again.
  Post Number #4  
Old 4th January 2018, 11:11 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,177
Re: Korea DMF (Drug Master File) Fees

Let us know what you found
  Post Number #5  
Old 4th January 2018, 12:12 PM
hs0wca

 
 
Total Posts: 4
Re: Korea DMF (Drug Master File) Fees

I tried to cut and paste the links but as I am a newbie it wouldnt allow it.

I found

"Regulation on fees for pharmaceutical approval etc." on the MFDS Website and
the NIFDS Guide to Drug approval system in Korea

The later refers to a MFDS Regulation on Registrations of Drug Substances (DMF) but I have been unable to locate this on the MFDS web site.

MFDS "Regulation on Pharmaceutical Approval Notiicaiton and Review" indicates in article 4 that you need to complet the "attached Form No 4". However there appears to be no attachment that I can see.

I suspect that the documents maybe available on the Korean website and not available yet translated into English.

Thanks.
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