What Was Announced on October 23: The Second Regulatory Rationalization Committee and MFDS's Bio Plan
On October 23, 2026, the President chaired the second plenary meeting of the Regulatory Rationalization Committee at Yeongbingwan, the Cheong Wa Dae state guest house. At that meeting, the Ministry of Food and Drug Safety (MFDS) presented a plan to bring bio regulation "up to the level of competitor countries." Press reports put the number of tasks at six.
This article covers two of them:
The CDMO export-manufacturing license, the raw-material certification (under the special act taking effect December 31), and the review standards for AI-enabled drugs are separate matters, so they are not covered here.
Keep in mind that this announcement sets out a policy direction. Detailed requirements and effective dates will be fixed through amendments to MFDS notices and enforcement rules, followed by administrative pre-announcements. Throughout this article, we separate what has been reported from what still needs to be confirmed.
Why Pre-Approval Batches Had to Be Scrapped
To file for marketing authorization, a company must produce process performance qualification (PPQ) batches and pilot batches in advance. Because these batches were made before approval, they could not be released. The usual result was to scrap them and manufacture again once approval came through.
The loss is largest for high-value biologics and low-volume products. Suppose a product costs KRW 300 million per batch and is validated with three batches. That means roughly KRW 900 million is written off. If raw materials take six months to arrive, re-manufacturing also pushes the launch back by about that long.
The US and EU let manufacturers build pre-approval inventory at their own risk. The inventory must be made under GMP exactly as described in the application, and it can be released once approval is granted. "Competitor-country level" is best read as a commitment to close that gap.
Conditions for Post-Approval Sale
Press reports confirm three conditions:
The third condition is the most important in practice. If the manufacturing process or specifications change during review, for example in response to a deficiency letter, batches made before the change will likely fall outside the scope. Full traceability between change history and batch records will decide whether those batches can be sold.
The following items should be confirmed in the follow-up notice:
Lighter Review Burden for Generics and OTC Drugs
According to press reports, some data requirements will be waived or replaced with alternative tests depending on the ingredient and dosage form. Products whose equivalence is self-evident, such as aqueous injectables, will be exempt from submitting equivalence data.
Some dosage forms already qualify for alternative testing under the current rules. What matters is how far the new plan extends the existing waivers, and that has to be checked against the actual notice text.
SMEs should review their product portfolios in two groups:
A single bioequivalence study typically costs several hundred million won and takes months. Companies may want to put the money and time saved into their next products. It is also worth considering how this ties into existing programs such as the drug-pricing reform and the semi-innovative pharmaceutical company certification.
What to Do Now: A Checklist for Batch Planning and Documentation
How KITIM Can Help
The Korea Institute of Technology Innovation Management (KITIM) supports the following work:
If your batch plans and documents are ready before the follow-up notice is issued, you can start cutting inventory losses as soon as the rule takes effect. If you have products heading for approval, please reach out through KITIM's consultation request page.