MFDS Issues Quality Guidance for Ophthalmic Drugs

The Ministry of Food and Drug Safety (MFDS) has established guidelines on quality control for drugs applied directly to the eyes, including ophthalmic solutions and ointments.

The National Institute of Food and Drug Safety Evaluation said it established the “Quality Guidelines for Topical Ophthalmic Drugs” on the 31st.

Drugs used in the eye are applied directly to the cornea, conjunctiva and other tissues, requiring quality control tailored to product forms such as solutions, suspensions and ointments. However, detailed guidance reflecting the characteristics of each dosage form had not been available.

In response, MFDS developed the guidance by gathering input from experts and industry through the New Technology and New Concept Drug Guideline Development Project (NEXT-G), which is being launched this year.

The guidelines cover quality design and evaluation methods suited to each product form; manufacturing and control methods to prevent microbial contamination; safety evaluation methods for containers and packaging; and considerations for quality testing and establishing shelf life.

In particular, the guidelines call for checking the distribution of drug ingredients in suspension eye drops after shaking before use. For multidose eye drops, they call for evaluating measures to prevent microbial contamination during use and whether quality is maintained after opening.

MFDS said it expects the guidelines to support pharmaceutical companies in product development and preparation of regulatory submissions, and to help ensure that quality-assured ophthalmic drugs are supplied to the public.

The guidance is available under Legal Information on the MFDS website (www.mfds.go.kr). Related educational and promotional videos can also be viewed using a QR code.