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Quality and Efficacy Consistency Evaluation for Generic Eye Drops Officially Launched; viwit Proactively Aligns Its Ophthalmic Portfolio with New Regulatory Requirements
Author：
VIWIT
Release Time：
2026-09-30
On September 2, 2026, China’s National Medical Products Administration (NMPA) issued Announcement No. 86 of 2026, announcing the phased expansion of the quality and efficacy consistency evaluation of generic drugs to additional dosage forms, including eye drops, transdermal patches, and sprays. Under the announcement, consistency evaluation for generic eye drops took effect on the date of issuance, while evaluations for transdermal patches and sprays are scheduled to begin on July 1, 2027.
This marks the formal launch of quality and efficacy consistency evaluation for generic eye drops in China.
Regulatory Context — A Phased Rollout by Dosage Form
The new requirements represent the latest step in the continued expansion of China’s generic drug quality and efficacy consistency evaluation program, rather than a standalone regulatory initiative.
In 2024, the General Office of the State Council issued the Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote the High-Quality Development of the Pharmaceutical Industry (State Council General Office [2024] No. 53), which explicitly called for the gradual expansion of generic drug quality and efficacy consistency evaluation to dosage forms including eye drops, transdermal patches, and sprays. On September 2, 2026, the NMPA formally implemented this policy through Announcement No. 86.
The progression of China’s consistency evaluation program reflects a clear and phased regulatory approach. The program was first introduced for oral solid dosage forms in 2016 and was subsequently expanded to injectable products. It has now advanced, as planned, to more complex dosage forms, including eye drops.
On the same day, the Center for Drug Evaluation (CDE) of the NMPA issued the Technical Guideline for the Study of Chemical Generic Eye Drops and the Technical Guideline for the Study of Special Chemical Generic Eye Drops, providing specific technical standards and a regulatory review framework for consistency evaluation in this category.
What Does This Mean for the Industry?
Quality and efficacy consistency evaluation represents a key technical requirement for generic drug market access in China. Historically, eye drop products were not subject to mandatory consistency evaluation, and no unified standardized evaluation framework had been established to assess their quality and therapeutic equivalence.
The inclusion of eye drops within the consistency evaluation framework introduces more comprehensive requirements for pharmaceutical companies across formulation and process development, quality control, and clinical development capabilities.
Companies whose products have not yet completed consistency evaluation will need to conduct systematic studies and submit regulatory applications based on the NMPA’s published catalogues of reference preparations. Depending on the characteristics of the individual product, clinical studies may also be required.
For companies whose products have already met the applicable consistency evaluation requirements, the regulatory transition provides an opportunity to establish an early-mover position as industry standards continue to rise.
How Has viwit Prepared?
Well before the new requirements were introduced, viwit had already established a forward-looking presence in ophthalmic therapeutics, with a portfolio spanning refractive disorders, dry eye disease, ocular allergy, glaucoma, and other therapeutic areas.
In 2022, viwit completed construction of an integrated Blow-Fill-Seal (BFS) production line for ophthalmic products. BFS technology integrates container formation, filling, and sealing within a continuous aseptic manufacturing process and is widely recognized as an advanced manufacturing approach for sterile ophthalmic drug products.
At the product level, 0.1% Olopatadine Hydrochloride Eye Drops (威士明®) received marketing approval in April 2023. The product was approved as a Class 4 chemical drug and is therefore deemed to have passed the quality and efficacy consistency evaluation.
This was followed by approvals for Brimonidine Tartrate Eye Drops (威立亮®) and Bimatoprost Eye Drops (威立靓™). Brimonidine Tartrate and Timolol Maleate Eye Drops — 5 mL containing 10.0 mg of brimonidine tartrate and 25.0 mg of timolol maleate, calculated as timolol — have also received marketing approval.
viwit has consistently benchmarked its operations against high global quality standards and established a current Good Manufacturing Practice (cGMP) quality management and control system aligned with international requirements. From obtaining certification under China’s revised GMP requirements in 2015 to successfully completing multiple U.S. Food and Drug Administration (FDA) on-site cGMP inspections since 2026, viwit has continued to strengthen its international quality management system, providing systematic support for the compliant commercialization of its products.
It is this long-term commitment to building robust, system-based capabilities that enables viwit to respond effectively to evolving regulatory requirements and remain well positioned as industry standards continue to advance.