Eye drop consistency evaluation starts today! These major varieties should be paid special attention to. The full coverage of CATO impurity reference standards can be checked.

Recently, the State Food and Drug Administration issued the "Announcement on Carrying out the Quality and Efficacy Consistency Evaluation of Generic Drugs in Other Dosage Forms of Chemical Drugs (Except Oral Solid Preparations and Injections)" (2026 No. 86), clarifying that the consistency evaluation will be gradually expanded to eye drops, patches, sprays and other dosage forms. Among them, the consistency evaluation of eye drops will be officially launched from the date of the announcement; the consistency evaluation of patches and sprays will be launched on July 1, 2027.

At the same time, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guiding Principles for the Research of Chemical Generic Drug Eye Drops" and the "Technical Guiding Principles for the Research of Special Eye Drops of Chemical Generic Drugs", which means that the consistency evaluation of eye drops has moved from policy deployment to the specific implementation stage. For relevant drug marketing authorization holders, how to select reference preparations, formulate research plans, establish impurity profiles and improve quality control systems will become the focus of subsequent consistency evaluation.

01

WHAT & WHY

What is eye drop consistency evaluation?

The consistency evaluation of quality and efficacy of generic drugs refers to the evaluation of the consistency in quality and efficacy of generic drugs on the market and reference preparations.

According to the requirements of Announcement No. 86 of the State Food and Drug Administration, eye drop drug marketing authorization holders should select reference preparations based on the "Chemical Generic Drug Reference Preparation Catalog" and carry out consistency evaluation, research and development and application work. Its main requirements include:

1. Conduct research in accordance with the relevant technical guidelines issued by the State Food and Drug Administration and the requirements of the Chinese Pharmacopoeia;

2. Please refer to the relevant technical requirements issued by foreign drug regulatory agencies;

3. In principle, the supplementary application for consistency evaluation is consistent with the technical requirements for marketing applications for chemical generic drugs;

4. The application materials shall be organized in accordance with relevant requirements and the current CTD format;

5. Submit an application to the Drug Evaluation Center of the State Food and Drug Administration in the form of a drug supplement application;

6. For varieties that require clinical trials, a clinical trial license must be obtained first;

7. After technical review, verification and inspection and passing the comprehensive review, the drug supplement application approval document will be issued.

💡 It should be noted that the announcement did not directly give a time limit for completing the evaluation of all eye drops. For varieties that have not yet been included in the "Catalogue of Reference Preparations for Chemical Generic Drugs", it is necessary to apply for and determine the reference preparation in accordance with regulations.

02

FOCUS

When evaluating the consistency of eye drops, what should you focus on?

Eye drops act directly on the eyes and have high requirements for product quality, sterility control and packaging systems. The key points of the evaluation mainly include:

1

Reference preparation:Confirm the source, specifications, packaging and batch of the reference preparation, and conduct comparative studies on critical quality attributes.

2

Prescription and process:Study raw materials, pH value, osmotic pressure, viscosity and production process. For special eye drops such as suspension type and emulsion type, it is also necessary to pay attention to indicators such as particle size, crystal form, dispersion state and in vitro release.

3

Impurity Control:Combine the production process, preparation formulation and stability research to identify process impurities and degradation products, and establish specific analytical methods and reasonable limits.

4

Sterility and packaging:Examine the sterility guarantee, antibacterial efficacy, packaging sealing and stability after opening, and also pay attention to the adsorption, migration and interaction between the medicinal solution and packaging materials.

03

WATCHLIST

Which types of eye drops deserve special attention?

The announcement did not announce a fixed “list of major varieties”. Based on clinical use, market maturity, interest in generic research and development, and national centralized procurement, products such as sodium hyaluronate, levofloxacin, moxifloxacin, olopatadine, and diquafosol sodium have received relatively high attention and can be the focus of this product review.

From the perspective of treatment fields, related varieties mainly cover anti-infection, anti-inflammation, anti-allergy, glaucoma, dry eye, immune regulation and other directions. For specific product and CATO impurity reference information, see the full index below.

📌 Whether a specific product is suitable for consistency evaluation still needs to be judged based on its approval status and the "Chemical Generic Drug Reference Preparation Catalog".

04

CATO SUPPORT

Research on Consistency Evaluation of CATO Boost Eye Drops

After the consistency evaluation of eye drops is officially launched, drug marketing authorization holders need to conduct systematic research on reference preparation selection, prescription process, related substances, degradation impurities, stability and packaging compatibility.

"Accurately identifying potential impurities, establishing a complete impurity spectrum and obtaining applicable impurity reference standards are important foundations for the development of analytical methods and the establishment of quality standards."

CATO has long been focused on the research and development and production of standard materials and drug impurities. It has been recognized by both CNAS and ANAB as ISO 17034 standard material producers, and can provide relevant standards and impurity reference material support for eye drop research and development, quality research and consistency evaluation projects.

Key support CATO can provide

• Double ISO 17034 reference material producer accreditation (CNAS + ANAB), quality system verifiable;

• A full set of impurity reference materials covering mainstream varieties of eye drops, most of which are available in stock;

• Comes with COA and HPLC/LC-MS/NMR/IR structure confirmation spectra;

• Support species → impurity list matching and assist in the design of impurity research plans.

Eye drops consistency evaluation · Large variety list

CATO Eye Drops Impurity Reference Standards Quick Check Sheet

The following is a collection of 34 eye drops varieties in 9 categories according to treatment categories. For each variety, a complete set of impurity reference standards can be found at CATO, and the COA and HPLC/LC-MS/NMR/IR spectra are attached with the goods.

💡Click on the variety name to view CATO’s full set of impurity reference standards

Data source: CATO (Guangzhou Jiatu Technology Co., Ltd.) official website, verification date 2026-09-16. The spot status and delivery date are subject to the real-time information on the official website page.

If you need to obtain the eye drops impurity reference substance, confirm the spot variety and delivery date, please contact us throughCATO official channelConsult us and we will match you with an exclusive impurity research plan.