Exclusive bulk drugs to be waived from the registration list of bulk products

The Korea Food and Administration (KFDA) has announced it will formulate its guideline covering the registration of bulk products (e.g., designation of bulk drugs, requirements for necessary data and scope of waiver) until this June, since the mandatory drug master file (DMF) system will be enforced by phases in this July, in a bid to strengthen the systematic surveillance for the imported subs...