Korea DMF (Drug Master File) Fees

[hs0wca]

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

 

[Ajit Basrur]

You can try -

Ministry of Food and Drug Safety
Republic of Korea Tel: (+82) 43 719-1564
Fax: (+82) 43-719-1550
Email: [email protected]

Also refer an existing thread
Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact?

 

[hs0wca]

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

Thanks again.

 

[Ajit Basrur]

Let us know what you found

 

[hs0wca]

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.

 

[Mallappa]

Hello Everyone,

I have few questions on the vaccine registration in South Korea.

1. Do the submission of master file for adjuvant required in South Korea for full license? if yes, what are the rules/ regulations for the acceptance of master file for adjuvant in South Korea?

2. What are the rules and regulations available for the export only vaccine in South Korea?

Looking forward for your inputs.

Thank you in advance.