MFDS Clarifies Approval and Review Standards for Quasi-Drugs... Reduces Data Submission Burden

[Financial News] The Ministry of Food and Drug Safety is taking steps to improve the system by reducing the burden of data submission for companies and clarifying review standards during the product approval, notification, and review processes for quasi-drugs.
On the 4th, the Ministry of Food and Drug Safety announced that it is issuing a notice of proposed amendment to the 'Regulations on Product Approval, Notification, and Review of Quasi-Drugs' to clarify the scope of data submission and review standards for quasi-drugs, and will accept comments until the 23rd.
The main contents of this amendment include: exemption from submitting a certificate of manufacture when importing quasi-drugs subject to mandatory GMP; establishment of new test items reflecting the characteristics of each product; and clarification of the scope of data to be submitted and review criteria for approval.
First, grounds are established to exempt the submission of a manufacturing certificate when importing quasi-drugs manufactured at a facility that has received GMP compliance. Previously, importers of quasi-drugs were required to submit a manufacturing certificate regardless of whether the facility had received GMP compliance.
The items exempt from the certificate of manufacture are liquid dosage forms, Oral Solid Dosage Forms, ointments specified in the standard manufacturing criteria, Cataplasma, etc.
New test items will also be established to consider the specific characteristics of each product category. By allowing the addition or omission of test items where there is a scientific basis, taking into account the product's characteristics and functions, the uniqueness of each item can be reflected.
The submission data and review criteria required for the approval process will also be specified. The cases requiring the submission of safety data will be clarified in relevant regulations, and standards will be revised to require the submission of culture medium performance test and microbial growth inhibition activity test data in accordance with The Korean Pharmacopoeia when microbial limit tests are established for finished products.
The Ministry of Food and Drug Safety expects that this amendment will reduce the burden of submitting unnecessary data for companies preparing for approval and review, and increase the predictability of the review process.
An official from the Ministry of Food and Drug Safety stated, "We will actively collect and reflect industry opinions during the administrative notice period," adding, "We will continuously improve related systems to alleviate the burden of data submission and support the rapid approval of products."

[email protected] Jeong Sang-hee Reporter