MFDS to waive manufacturing certificates for GMP-compliant imported quasi-drugs and clarify testing and review standards

The Ministry of Food and Drug Safety (MFDS) is establishing a basis for waiving manufacturing certificate submissions for imported quasi-drugs and clarifying product-specific testing and review standards.

On the 4th, the MFDS announced that it had issued a proposed amendment to its Rules on Quasi-Drug Approvals, Notifications and Reviews for public comment, with comments accepted through the 23rd.

The proposal would allow manufacturing certificate submissions to be waived when importing quasi-drugs made at facilities that have received a determination of compliance with good manufacturing practice (GMP) standards for pharmaceuticals. The products covered are oral liquids, oral solids, ointments specified in the standard manufacturing guidelines, and cataplasms.

Until now, manufacturing certificates have been required for imported quasi-drugs regardless of whether the manufacturing facility complied with GMP standards.

The proposal also adds testing requirements that reflect the characteristics of each quasi-drug product, reducing the burden on companies preparing materials and improving predictability in reviews. Testing requirements may be added or omitted when supported by scientific evidence.

The proposal clarifies in the relevant provisions when stability data must be submitted. It also revises the standards to require submission of data on culture media performance testing and microbial growth inhibition testing, as specified in the Korean Pharmacopoeia, when microbial limit testing is established for the finished product.

The MFDS said it plans to gather and incorporate industry feedback during the public comment period and continue improving the system, including by easing the burden of submitting materials and supporting faster product approvals through the amendment.

The full text of the proposal is available under Laws and Data on the MFDS website (www.mfds.go.kr).