The October 16 Pre-Announcement: A Full Rewrite of Annex 11
On October 16, 2026, Korea's Ministry of Food and Drug Safety (MFDS) pre-announced a partial amendment to the Regulation on Good Manufacturing Practice for Medicinal Products. Its main change is a full rewrite of Annex 11, which governs the manufacture of investigational medicinal products (IMPs), to bring it in line with the latest PIC/S GMP guidance for IMPs. Comments are due November 5. As of October 26, about ten days remain.
This notice is separate from the amendment to the Enforcement Rule on the Safety of Pharmaceuticals pre-announced on August 21, which covers changes such as shorter clinical trial approval times. This article covers only the changes to manufacturing and quality standards. The effective date and transitional provisions may still change during consultation, so confirm them in the final notice.
Key Change 1: A Pharmaceutical Quality System (PQS)
The draft requires a structured quality system even at the clinical stage. Companies have often assumed that small-batch clinical supplies can follow looser rules than commercial GMP. That gap is now getting smaller.
Development work still involves frequent process changes and few batches, so a practical approach looks like this:
Key Change 2: A Mandatory Product Specification File (PSF)
The PSF brings together the specifications needed to manufacture, test, and release an IMP. Under the draft, it must include starting material specifications, manufacturing and in-process control methods, the stability study protocol, and a supply chain flow diagram, among other items. The PSF and batch manufacturing and testing records must be kept for at least five years after the trial ends or is formally discontinued.
Who Is Most Affected
Biotech sponsors without their own facilities, who rely on CMOs for clinical supply, need to prepare first. The CMO creates the records, but the sponsor carries ultimate responsibility for the trial. The quality agreement should state who drafts and who approves each PSF element.
Companies that use overseas materials or several outsourced steps will find the supply chain diagram demanding. For example, if the drug substance is imported, a domestic CMO handles fill, and another vendor handles labeling and packaging, the diagram must show every step, every vendor, and who is responsible for what.
Companies running multinational trials or pursuing licensing deals stand to benefit. Once Korean requirements match PIC/S, one documentation system can serve inspections by foreign regulators and due diligence by partners.
What to Do During Consultation and Before Implementation
If you plan to comment by November 5, focus on three questions:
To prepare for implementation, we recommend these steps:
The five-year clock starts when the trial ends. The longer a trial runs, the longer you will actually keep records from its earliest batches, so build that into your planning.
How KITIM Can Help
KITIM supports IMP GMP gap analysis, PSF template development, review of CMO quality agreements, and drafting of comments on the pre-announcement. If you are about to enter the clinic and want to check your quality documentation, or need a review before the November 5 deadline, please contact the KITIM consulting team. We will work with you on a plan that fits your development stage and outsourcing setup.