Korea to let drugmakers sell GMP-made products before approval

The food and drug safety ministry said Friday it will allow pharmaceutical companies to sell medicines manufactured before a product license is granted, a change from current rules under which such output must be discarded in full.

Manufacturers that meet conditions, including compliance with good manufacturing practice and production identical to the final approved specifications, will be permitted to sell the pre-approval stock. The measure was among a package of regulatory revisions presented the same day at the second full meeting of the Regulation Rationalization Committee, held at the presidential office's Yeongbingwan guesthouse.

The ministry framed the package as a bid to meet the standards of competing countries. It said it has already shortened the approval period to 240 days, which it described as the fastest in the world, and established the world's first regulatory framework for digital medical products.

For digital combination drugs, the ministry will set up product-specific joint response teams, prepare a standard operating procedure for one-stop integrated review and draw up guidelines for designing clinical trials, responding to industry complaints that classification, licensing and quality control standards for such products are unclear and that criteria for the clinical trials and real-world use evaluations needed for approval are not well defined.

For medicines developed with artificial intelligence, the ministry will issue review guidelines. It said no separate evaluation standard currently exists for AI-developed drugs, and that the guidelines are intended to cut the time and cost of developing new treatments.

The ministry also moved to ease the review burden on generics and over-the-counter medicines. Biological equivalence test data will no longer be mandatory for all generics: injectable solutions will be exempt from submitting supporting data, and eye ointments may use alternative tests that reflect the product's characteristics. Over-the-counter products, which have had to meet the same data requirements as prescription drugs, will see the scope of required submissions narrowed where the route of administration is the same and only the formulation differs, such as ointments and creams.

A special law on regulatory support for biologics CDMO companies, the first of its kind, is set to take effect on Dec. 31, 2026, and the ministry will build an export-oriented regulatory framework through a new export manufacturing business category, GMP certification and government certification of raw materials.

The ministry said it will keep communicating with industry to create a regulatory environment aligned with international standards and to take preemptive regulatory support so that Korea can establish itself as a leading country in global regulation of new biotechnology fields.