As Daewoo Pharmaceutical responds to strengthened aseptic pharmaceutical manufacturing standards, it has decided to suspend the production and contract manufacturing of prednisolone acetate eyedrops, prompting the Ministry of Food and Drug Safety (Minister Oh Yu-kyung) to secure alternative supplies.

The Ministry plans to respond to market demand by discussing increased production with Chong Kun Dang and AbbVie Korea, which supply eyedrops with the same active ingredient.

According to Daily Medi coverage on the 5th, Daewoo Pharmaceutical decided to halt the production and contract manufacturing of prednisolone acetate eyedrops due to factors such as compliance with EU GMP Annex 1—the strengthened aseptic drug manufacturing standards—and facility aging.

Although the company considered relocating to another production line following the shutdown of its existing manufacturing line, it concluded that current manufacturing methods and facilities would be unable to meet the strengthened aseptic standards.

EU GMP Annex 1, the background of this issue, sets forth manufacturing and quality control standards for sterile medicinal products. In Korea, the Ministry of Food and Drug Safety applies the revised regulation on the manufacturing and quality control of pharmaceuticals, "Manufacturing of Sterile Medicinal Products," in alignment with international standards.

The core of the revised standards is the establishment and implementation of a Contamination Control Strategy (CCS). Manufacturers must identify potential contamination risks across facilities, equipment, operators, raw materials, and manufacturing processes, and prove that preventive management systems operate effectively.

Domestic regulations also explicitly state that “sterility cannot be assured solely by monitoring or testing.”

Consequently, manufacturer responses entail not only facility improvements but also qualification and validation of modified processes.

Even when relocating a production line, a verification procedure is required to confirm that the product can be manufactured under sterile conditions in the new equipment and process.

However, the introduction of specific new equipment is not universally mandated for all companies. The regulations specify that replacement may not be necessary if existing management systems are operated appropriately, and require validity for alternatives such as Restricted Access Barrier Systems (RABS) or isolators that reduce contamination caused by operator intervention.

This structure allows the scope of response to vary depending on each company's existing facilities, processes, and validation capabilities.

MFDS Pursues Expansion of Alternative Supplies… Operates Aseptic GMP Technical Support and Consultation Channel

The Ministry of Food and Drug Safety stated, “We understand that supply suspension issues arise from complex factors such as drug pricing and management reasons. Accordingly, we are comprehensively analyzing the availability of alternative drugs and the necessity of supply in medical settings to take necessary measures, including monitoring.”

Regarding the burden of facility improvement costs and process validation periods for the industry, the Ministry presented the application of regulatory grace periods and the operation of technical support and consultation systems.

The Ministry explained, “To harmonize sterile pharmaceutical GMP standards internationally, we revised the sterile pharmaceutical GMP regulations in December 2023, and granted a grace period of 2 to 3 years for the industry’s smooth adaptation.”

It added, “To support the pharmaceutical industry in successfully settling in through the formulation of implementation plans for the revised regulations, we are operating the ‘Global GMP Implementation Technical Support Consultative Body,’ in which the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and 30 companies participate. We also operate a communication channel, the ‘GMP Regulatory Harmonization Consultation (Hotline),’ jointly with the pharmaceutical association.”

Following Daewoo Pharmaceutical’s supply suspension, the scale and timing of alternative item supply expansion will be pivotal factors.

The Ministry stated, “Regarding Daewoo Pharmaceutical's supply volume, we plan to ensure that market demand is met through discussions on increased production with the two domestic companies currently supplying eyedrops containing the relevant ingredient: Chong Kun Dang (manufacturing) and AbbVie Korea (importing). We will continuously monitor the supply and demand situation of the medicinal products in question.”

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