NMPA Grants Class II TCM Variety Protection to Five Products – Seven‑Year Exclusivity Runs Through 2033

Beijing, China – 04 Sep 2026 – China’s National Medical Products Administration (NMPA) announced that, pursuant to the Regulations on the Protection of Traditional Chinese Medicine Varieties, five traditional Chinese medicine (TCM) products have been approved as first‑instance Class II protected TCM varieties, each receiving a protection term of seven years from the announcement date. The designated products are Jinrong Granules of Guangzhou Qiji Pharmaceutical Technology Co., Ltd., Compound Ciwujia Granules of Heilongjiang Hanhong Pharmaceutical Co., Ltd., Xiao’er Chaigui Antipyretic Oral Liquid of Jilin Aodong Yanbian Pharmaceutical Co., Ltd., Danlong Oral Liquid of Zhejiang Kangde Pharmaceutical Group Co., Ltd., and Compound Shangtong Capsules of Licai Gansu Xifeng Pharmaceutical Co., Ltd. (Announcement No. 38, 2026 No. 89).

Regulatory Milestone

ItemDetail
AgencyNMPA (China)
AnnouncementAnnouncement on Protected TCM Varieties No. 38 (2026 No. 89)
Legal BasisRegulations on the Protection of Traditional Chinese Medicine Varieties
DesignationClass II protected TCM varieties – first instance (initial protection)
Protection TermSeven years from the announcement date (through September 2033)
Announcement Date4 September 2026

Protected Products & Manufacturers

ProductManufacturerProtection No.
Jinrong Granules (金蓉颗粒)Guangzhou Qiji Pharmaceutical Technology Co., Ltd. (private)ZYB2072026021
Compound Ciwujia Granules (复方刺五加颗粒)Heilongjiang Hanhong Pharmaceutical Co., Ltd. (private)ZYB2072026019
Xiao’er Chaigui Antipyretic Oral Liquid (小儿柴桂退热口服液)Jilin Aodong Yanbian Pharmaceutical Co., Ltd. – affiliate of listed Jilin Aodong Pharmaceutical Group (000623.SZ)ZYB2072026020
Danlong Oral Liquid (丹龙口服液)Zhejiang Kangde Pharmaceutical Group Co., Ltd. (private)ZYB2072026023
Compound Shangtong Capsules (复方伤痛胶囊)Licai Gansu Xifeng Pharmaceutical Co., Ltd. (private)ZYB2072026022
  • Dosage Forms Covered: granules, oral liquids, and capsules – reflecting the breadth of TCM manufacturing formats recognized in this batch.
  • Indications & Clinical Data: Not restated in the announcement; no therapeutic claims or trial figures were disclosed.

Protection Framework – Class II TCM Variety Status

  • Scope: Under the TCM Variety Protection Regulations, a protected variety enjoys market exclusivity during the protection term; unauthorized enterprises may not produce the same variety, subject to statutory procedures for prior producers within prescribed deadlines.
  • Term Structure: Initial Class II protection runs seven years – consistent with the term stated in the announcement; holders may apply for extension upon expiry in accordance with the regulations.
  • Strategic Value: The designation functions as a TCM‑specific exclusivity instrument, complementing patents and trade‑secret protection to deter copycat production of established formulations.

Market Impact & Outlook

  • Exclusivity Window: All five varieties are shielded through September 2033, granting holders a multi‑year moat against new entrants seeking to launch the same formulations.
  • Listed‑Company Angle: Jilin Aodong Pharmaceutical Group (000623.SZ) reinforces its pediatric product portfolio through the protection of its Yanbian affiliate’s Xiao’er Chaigui Antipyretic Oral Liquid; the remaining four holders are private companies.
  • TCM Policy Tailwind: The batch designation aligns with Beijing’s sustained policy support for TCM innovation and quality upgrading, with the NMPA deploying the variety‑protection system to reward established products.
  • Financial Impact: Revenue contribution and pricing implications were not disclosed in the announcement.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the regulatory status, protection timelines, and commercial expectations for the five protected TCM varieties. Actual outcomes may differ due to risks including extension decisions, changes in TCM regulation, market competition, and pricing policy.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/zhybhpzh/zhybhpzhgg/20260908150355107.html

CMDE Opens Consultation on Two Draft Registration Review Guidance Documents for Medical Devices – Software for Laparoscopic Endoscopy Systems and Medical Oxygen Chambers

Beijing, China – 08 Sep 2026 – The Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) has released for public comment two draft registration review guidance documents — “Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems, Part 6: Software” and “Registration Review Guidelines for Medical Oxygen Chambers” — with feedback due by 8 Oct 2026.

Regulatory Milestone

ItemDetail
Issuing AuthorityCMDE, NMPA
Notice TypePublic consultation on draft registration review guidance
Document 1Registration Review Guidelines for Laparoscopic Endoscopy Surgery Systems – Part 6: Software (Draft for Comments)
Document 2Registration Review Guidelines for Medical Oxygen Chambers (Draft for Comments)
Policy BasisNMPA work plan for formulation and revision of medical device registration review guidance
Publication Date8 Sep 2026
Comment Deadline8 Oct 2026
Submission MethodCompleted feedback form (Attachment 3) by email, with subject/file naming convention

Guidance Documents Under Consultation

  • Laparoscopic Endoscopy Software (Part 6): The draft addresses the software component of laparoscopic endoscopy surgery systems — in China’s classification, the device category that also covers robot‑assisted minimally invasive surgery systems. As the sixth part of a multi‑part guidance series, it is set to standardize registration review expectations for system software, a critical compliance reference for both domestic surgical‑robot developers and imported platforms seeking NMPA clearance.
  • Medical Oxygen Chambers: The draft provides dedicated registration review guidance for hyperbaric oxygen therapy chambers, a device class spanning hospital‑grade multi‑place chambers and smaller monoplace units used in clinical oxygen therapy. Final guidance will give manufacturers a consolidated benchmark for technical documentation, safety and performance review.

Feedback Procedure

  • Form Requirement: Comments must be submitted on the official feedback form (Attachment 3); both draft guidance texts are available for download alongside the notice.
  • Naming Convention: Email subjects and file names must follow the format “Feedback Organization + 《Guidance Title》 Feedback.”
  • Contact – Document 1 (Endoscopy Software): Mr. Zhang Chenguang, tel. 010‑86452649, email zhangcg@cmde.org.cn.
  • Contact – Document 2 (Oxygen Chambers): Mr. Liu Xiaoyin and Ms. Wu Jiangyan, tel. 010‑86452634 / 021‑68662198, emails liuxy1@cmde.org.cn and wujy@ydcmdei.org.cn — the Shanghai‑area contact indicating co‑drafting input from a regional evaluation partner.

Market Impact & Outlook

  • Surgical Robotics Compliance Roadmap: For developers in China’s fast‑expanding laparoscopic surgical‑robot sector, Part 6 on software will sharpen expectations on software description, versioning, cybersecurity and standalone‑software documentation — reducing registration ambiguity but raising the bar for pre‑submission preparation.
  • Hyperbaric Equipment Standardization: A dedicated guidance for medical oxygen chambers signals maturation of that niche market, with clearer review criteria likely to benefit established manufacturers and streamline entries by new applicants.
  • One‑Month Comment Window: The 8 Oct deadline gives industry a short, defined window to shape final texts; manufacturers and trade associations with pending or planned registrations in either category should review the drafts promptly, as final guidance will directly frame technical review dossiers.
  • Guidance Cadence: The consultation continues the CMDE’s systematic build‑out of device‑category‑specific review guidance under the NMPA’s multi‑year formulation plan, reinforcing a rules‑based, increasingly transparent registration pathway for medical devices in China.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding the consultation process, final content of the two guidance documents, and their impact on device registration timelines. Actual outcomes may differ due to risks including revisions between draft and final versions, feedback evaluation, and subsequent NMPA/CMDE policy actions.-China Health Reform Pulse

Policy Source: https://www.cmde.org.cn/xwdt/zxyw/20260908165732174.html

China Issues 2026–2030 Eye Health Work Plan – Cataract Surgery Rate to Top 4,000 Per Million, Universal County Cataract Services and AI‑Empowered Screening by 2030

Beijing, China – 28 Aug 2026 – The National Health Commission (NHC), the National Administration of Traditional Chinese Medicine (NATCM) and the National Disease Prevention and Control Administration (NDCP) have jointly issued the “Work Plan for Accelerating the Provision of High‑Quality and Efficient Eye Health Services (2026–2030)” (Guo Wei Yi Zheng Fa [2026] No. 22), directing provincial authorities to implement a nine‑task, full‑life‑cycle eye‑care framework that sets binding 2030 targets for cataract surgery rates, ophthalmologist density, county‑level service capability, and explicitly promotes artificial‑intelligence empowerment across screening and diagnosis.

Policy Milestone

ItemDetail
Issuing AuthoritiesNHC, NATCM, NDCP (joint)
DocumentWork Plan for Accelerating High‑Quality and Efficient Eye Health Services (2026–2030)
Document No.Guo Wei Yi Zheng Fa [2026] No. 22
Issuance Date28 Aug 2026 (proactive public disclosure)
Policy Period2026–2030 (“15th Five‑Year Plan” window)
Policy AnchorHealthy China 2030 Outline and National Health “15th Five‑Year” Plan
Guiding ApproachPrevention first, medical‑prevention integration, equal TCM/Western‑medicine emphasis, multi‑disease co‑prevention and co‑management; shift from disease‑centered to health‑centered care
RecipientsProvincial health, TCM and disease‑control authorities, incl. Xinjiang Production and Construction Corps

2030 Targets

IndicatorTarget by 2030
Refractive Screening & CorrectionSteadily higher screening rates for children aged 0–6 and primary/secondary students; eREC (effective refractive‑error coverage) continuously rising; stronger correction awareness among the elderly
Cataract Surgery Rate (CSR)>4,000 per million population; eCSC (effective cataract surgical coverage) continuously rising
Workforce>5.3 ophthalmologists (practicing/assistant) per 100,000 population; expanded optometrist ranks
County Capability>93% of county general hospitals with an ophthalmology (ENT‑ophthalmology) department; >95% of counties independently treating common eye diseases; all counties able to deliver cataract surgery; expanding basic vision‑care and low‑vision rehabilitation coverage

Nine Task Areas

  • Risk Prevention & Health Literacy: Launch the “Hundreds‑Thousands‑Tens of Thousands” eye‑health education action100 provincial‑level, 1,000 prefecture‑level, and 10,000 grassroots outreach events targeting children, the elderly, and key occupational groups, timed with National “Love Eye Day,” World Sight Day and World Glaucoma Week; integrate eye‑complication prevention into chronic‑disease management.
  • Tiered Service System: Tertiary and specialty eye hospitals handle acute, severe and complex cases; secondary hospitals manage common diseases and upward referral; township/community centers are encouraged to offer optometry and fundus photography; village clinics provide vision checks and education. Tight‑knit county medical communities and urban medical groups channel technology, remote guidance and training downward — including retired medical staff serving resource‑weak western and grassroots regions.
  • Early Screening: Strengthen newborn eye‑disease screening and vision checks for children aged 0–6 (detecting insufficient hyperopic reserve early); compile a key‑population screening catalogue covering refractive error, diabetic retinopathy, cataract and glaucoma for children, middle‑aged/elderly, and diabetes/hypertension patients; issue grassroots screening and referral guidelines.
  • Standardized Care: Revise ophthalmic diagnosis/treatment guidelines and technical norms; build specialty quality‑control indicator systems; expand day‑surgery and outpatient‑surgery categories and raise their share of elective procedures.
  • Low‑Vision Rehabilitation: Embed rehabilitation into the full care pathway; promote the “assessment–fitting–training–follow‑up” service model and build capacity in visual‑disability evaluation and assistive devices.
  • Key Disease Programs: Implement WHO’s “SPECS 2030” refractive‑care initiative; enforce myopia‑prevention guidelines with early warning for high myopia; deliver integrated TCM–Western myopia control for children; consolidate cataract blindness‑elimination gains via paired assistance, mobile medical tours and “Bright Journey” (光明行) programs; optimize care models for fundus diseases and glaucoma with AI integration, tiered diagnosis and two‑way referral with mutual result recognition; standardize eye banks and corneal‑transplant oversight; sustain blinding‑trachoma elimination; regulate retinopathy of prematurity care; build capacity in ocular trauma, strabismus/amblyopia, and rare and hereditary eye diseases.
  • TCM Synergy: Develop TCM‑specific intervention guidelines for eye health; build integrated Chinese–Western medicine “flagship” departments; extend acupuncture and acupoint‑application therapies to grassroots institutions.
  • AI & Digital Empowerment: Deep‑integrate AI, big data and 5G with eye services under the “Internet+” medical model; scale tele‑ophthalmology for remote consultation, image interpretation and follow‑up; explore medical‑AI applications in grassroots screening, assisted diagnosis, patient services, public health, research and the health industry.
  • Talent & Science: Strengthen standardized residency training and continuing education; cultivate optometrists, ophthalmic nurses and low‑vision rehabilitation specialists; conduct epidemiological surveillance of blinding diseases and their socioeconomic burden.

County Cataract Build‑Out Formula

  • Counties with resident population ≥300,000: at least one county hospital must independently perform cataract surgery, via equipment provision, personnel training and quality strengthening.
  • Counties with population <300,000: cataract surgery delivered primarily through organized mobile/visiting medical services (巡诊).

Key Metrics Defined (Official Annex)

  • eREC: Share of people receiving high‑quality refractive correction (glasses, contact lenses, or surgery) among those needing it — covering both distance and near vision.
  • eCSC: Share of people aged 50+ with good post‑operative distance vision among those needing cataract surgery; China will apply 6/12 and 6/18 dual vision standards in line with WHO flexibility guidance.
  • SPECS 2030: WHO initiative spanning Services access, Personnel capacity, Education, Cost reduction, and Surveillance.

Market Impact & Outlook

  • Surgical Volume Tailwind: The CSR >4,000 per million target, universal county cataract capability, and expanded day‑surgery categories point to sustained growth in cataract procedures, IOL implants, phacoemulsification equipment and surgical consumables through 2030.
  • Screening Infrastructure Demand: Newborn screening, fundus photography pushed down to township level, and a formal screening catalogue create procurement demand for fundus cameras, optometry equipment, and vision‑screening devices at the primary‑care tier.
  • AI Deployment Mandate: Explicit endorsement of AI in grassroots screening and assisted diagnosis — with fundus‑disease management as a named pilot area — opens a regulated pathway for AI ophthalmology diagnostic software vendors, with county and community institutions as the natural first market.
  • Refractive & Myopia‑Control Economy: SPECS 2030 implementation, eREC as a tracked indicator, and TCM‑integrated myopia programs institutionalize recurring demand across optical retail, myopia‑control products (e.g., ortho‑k, defocus lenses) and pediatric vision services.
  • Workforce as Capacity Unlock: The 5.3‑per‑100,000 ophthalmologist floor plus optometrist, nursing and rehabilitation training targets address the sector’s core bottleneck, supporting both public capacity and private ophthalmic chain expansion.

Implementation Structure

  • Health authorities at all levels lead whole‑population, whole‑life‑cycle implementation; TCM departments promote appropriate technologies and integrated care; disease‑control departments run myopia surveillance and intervention for students.
  • Provincial authorities tailor implementation measures and establish progress monitoring and evaluation mechanisms; the NHC will conduct research and guidance on plan execution as appropriate.

Forward‑Looking Statements
This brief contains forward‑looking statements regarding implementation timelines, service‑coverage targets, workforce expansion, county capability build‑out, and technology adoption under China’s 2026–2030 Eye Health Work Plan. Actual outcomes may differ due to risks including provincial execution capacity, funding allocation, training pipelines, AI regulatory approval, and evolving clinical standards.-China Health Reform Pulse

Policy Source: https://www.nhc.gov.cn/yzygj/c100068/202609/306f00c939424aadb79999b96353f36f.shtml