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

Beijing — China’s National Medical Products Administration (NMPA) has ordered a unified revision of the package insert and label for all inosine injection products, requiring marketing authorization holders to file updated documentation with provincial drug regulators before Dec. 1, 2026, following an agency assessment of adverse drug reaction data.

Compliance Snapshot

Attribute	Detail
Announcement	NMPA Announcement No. 87 of 2026
Product scope	All inosine injection products
Action required	Unified revision of package insert (and label, where affected)
Filing deadline	Dec. 1, 2026
Filing authority	Provincial-level drug regulatory departments
Post-filing timeline	Inserts/labels of distributed stock replaced or patients otherwise informed within 9 months

Clinical Context

Inosine injection, a nucleoside-based metabolic agent, is widely used in China as an adjunct therapy in hepatology, cardiology and hematology settings, including leukopenia and hepatic injury. The NMPA’s decision stems from its post-market adverse drug reaction evaluation program, under which the agency periodically screens nationwide ADR reporting data to identify emerging safety signals in established products. While the announcement does not disclose the specific newly identified reactions, it directs marketing authorization holders to conduct in-depth research into the mechanisms of the added adverse reactions and to strengthen training for physicians and pharmacists on rational use.

Market Impact Analysis

The directive signals the NMPA’s continued tightening of lifecycle safety management for long-marketed injectables, a category that has faced escalating scrutiny since China’s drug administration law reforms placed primary safety accountability on marketing authorization holders. Inosine injection is produced by dozens of domestic manufacturers, meaning the revision effectively resets the labeling baseline for the entire product class at once—a compliance exercise spanning insert revision, label redesign, inventory rotation and patient notification.

For holders, the commercial stakes are modest but the compliance risk is real: products manufactured from the filing date may not use the original insert, and a nine-month window is granted to replace inserts and labels of already-distributed stock or otherwise inform patients of the updates. Provincial regulators are explicitly tasked with enforcement, with violations to be strictly investigated and penalized. The requirement that holders research the mechanisms of newly added adverse reactions and run physician and pharmacist training programs suggests regulators expect the label changes to carry clinically material safety information rather than cosmetic edits.

Forward-Looking Statement

Industry observers expect provincial filings to cluster ahead of the Dec. 1 deadline, followed by a nine-month label-replacement cycle extending into late 2027 for distributed inventory. Clinicians are advised to incorporate the revised benefit-risk profile of inosine injection into prescribing decisions, while patients using the drug should read the updated insert and follow medical guidance strictly. Broader implications point toward continued ADR-driven label harmonization across other legacy injectable products, reinforcing the NMPA’s shift from approval-centric oversight to full lifecycle pharmacovigilance.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20260904163246192.html