Beijing, China – 08 Sep 2026 – China’s National Medical Products Administration (NMPA) published the eighth batch of its pilot list for the age-friendly and barrier-free reform of drug package inserts (labels), adding 483 drug products submitted by marketing authorization holders (MAHs) through provincial drug regulators and the NMPA Center for Drug Evaluation (CDE). The list spans chemical drugs, traditional Chinese medicines (TCM) and biologics from both domestic and multinational manufacturers.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Announcement Type | Pilot list publication (Batch 8) |
| Policy Basis | NMPA Announcement No. 142 of 2023 – Pilot Work Plan for Age-Friendly and Barrier-Free Reform of Drug Package Inserts |
| Products Added | 483 drug products |
| Publication Date | 8 Sep 2026 |
| Next Steps | Listed MAHs to implement revised, accessible labeling for pilot products |
Batch 8 Profile
- Composition: Predominantly chemical drugs and TCM, with a portion of biologics; products from Jiangsu, Guangdong and Fujian provinces are prominently represented.
- Therapeutic Coverage: Medicines for chronic and common diseases — diabetes, hypertension, bronchial asthma, rheumatoid arthritis — alongside oncology and major-disease therapies for lung, breast and prostate cancer.
- Featured Products: Bosentan Tablets (Beijing Sihuan Kebao Pharmaceutical); Celecoxib Capsules (CSPC Group Ouyi Pharmaceutical); Tuonuodafei Hydrochloride Tablets (Yangtze River Pharmaceutical Group), a recently approved Class 1 innovative PDE5 inhibitor; Ustekinumab Injection (Hangzhou Sino‑American Huadong Pharmaceutical); Xiangsha Lizhong Wan (Fuzhou Haiwang Jinxiang TCM Pharmaceutical); Capivasertib Tablets (AstraZeneca UK Limited); Infliximab for Injection (Janssen‑Cilag International NV).
- Reform Scope: Pilot products may adopt accessible labeling formats — enlarged print, prominent presentation of critical information, and electronic or alternative-format inserts — to serve elderly and visually impaired patients.
Pilot Program – Expansion to Date
- Launch: The pilot work plan was released in late October 2023; the first batch followed in late December 2023.
- Cumulative Reach: Eight batches now cover 3,671 drug products in total.
- Accelerating Pace: Three batches published year-to-date in 2026, incorporating 1,906 products — more than half of the program’s cumulative total — signaling markedly faster expansion.
Market Impact & Outlook
- Patient Safety: Improved label readability directly targets medication errors among elderly patients, a growing concern as China’s population ages rapidly.
- Industry Compliance: The steady widening of the pilot suggests MAHs should anticipate accessible-labeling expectations becoming an industry norm, potentially extending beyond pilot status.
- Multinational Participation: Inclusion of AstraZeneca and Janssen‑Cilag products indicates global sponsors are aligning China labeling operations with the reform, mirroring accessibility trends in other major markets.
- Regulatory Trajectory: With the 2026 publication cadence tripling coverage, a transition from voluntary pilot toward broader mandatory implementation appears increasingly plausible.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, the scope of future pilot batches, and industry compliance expectations for China’s age-friendly drug label reform. Actual outcomes may differ due to changes in NMPA policy, implementation schedules, and manufacturer adoption.-China Health Reform Pulse
Policy Source: https://www.nmpa.gov.cn/yaopin/ypjgdt/20260908141654101.html