Republic of Korea - Proposed amendments to the "Regulation on Approval and Review of Biological Products" :

Ministry of Food and Drug Safety has issued notification on proposing amendments to the "Regulation on Approval and Review of Biological Products". The proposed amendments as follows;

• When applying for product approval, the submission of certificate of sale for cell therapy products and gene therapy products that are developed in Korea and manufactured overseas (except for new drugs) are waived.
• Cell therapy products used to treat life threatening or severe irreversible diseases may be approved based on the therapeutic exploratory clinical study data on condition that therapeutic confirmatory clinical study data will be submitted at a later date.
• In cases where clinical studies for orphan drugs are difficult to be conducted due to the limited number of relevant patients, the number of clinical study objects may be adjusted accordingly.
• The scope of diseases for which the fast track approval route may be applied has been expanded, and relevant product designation procedures have been specified.

Data requirements for product approval have been eased.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

Final date for comments: 60 days from notification

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.