Policy & Regulation
Proposed amendment to regulations on approval, notification and review of quasi-drug products announced for public comment New product-specific test items…submission requirements and review standards revised
The Ministry of Food and Drug Safety (MFDS) has announced a proposed amendment to its notice that would establish grounds for waiving manufacturing certificate submissions for imported quasi-drugs and clarify product-specific testing and review standards.
On the 4th, MFDS announced the proposed amendment to the Regulations on Approval, Notification and Review of Quasi-Drug Products and said it would accept comments through the 23rd.
The proposal would first allow manufacturing certificate submissions to be waived for imported quasi-drugs made at manufacturing sites that have received a determination of compliance with good manufacturing practice (GMP). The products covered are oral liquids, oral solids, ointments that comply with standard manufacturing criteria, and cataplasma products.
Until now, manufacturing certificates had to be submitted for imported quasi-drugs regardless of whether they complied with GMP.
The proposal also adds test items that reflect the characteristics of each quasi-drug product, reducing the burden on companies preparing documentation and increasing the predictability of reviews. It would allow test items to be added or omitted based on product characteristics when supported by scientific evidence.
The proposal clarifies in the relevant provisions which products require stability data and revises the standards to require submission of data on culture media performance testing and microbial growth inhibition testing specified in the Korean Pharmacopoeia when microbial limit testing is established for a finished product.
MFDS said it plans to gather and incorporate industry feedback during the public comment period and continue improving the system, including by easing documentation requirements through this amendment to support faster product approvals.
The full text of the proposed amendment is available under Legal Information on the MFDS website (www.mfds.go.kr).
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