Beijing — China’s National Medical Products Administration (NMPA) expanded its generic drug quality and efficacy consistency evaluation program beyond oral solid dosage forms and injections, adding eye drops, transdermal patches, and sprays to the reform framework as Beijing deepens its push to upgrade the domestic pharmaceutical sector.

Policy Snapshot

Attribute	Detail
Issuer	National Medical Products Administration (NMPA)
Announcement	2026 No. 86
Legal basis	State Council General Office Opinion on Deepening Drug and Medical Device Regulatory Reform (Guo Ban Fa [2024] No. 53)
Scope	Chemical generic drugs in non-oral, non-injectable dosage forms
Initial phase	Eye drops — effective immediately upon announcement
Second phase	Patches and sprays — effective July 1, 2027
Reference standard	NMPA Chemical Generic Drug Reference Preparations Catalog

Key Provisions

• Expanded coverage — The consistency evaluation regime, previously focused on oral solids and injections, now extends to eye drops, transdermal patches, and sprays. Marketing authorization holders must select reference preparations from the NMPA-published catalog and submit consistency evaluation applications.
• Technical alignment — Supplemental applications for consistency evaluation must meet the same technical standards as new chemical generic drug applications. Holders should conduct studies according to NMPA technical guidelines and Chinese Pharmacopoeia standards, with the option to reference foreign regulatory requirements. Application summaries follow the 2020 No. 2 CDE notice on injection consistency evaluations; other sections follow the current M4 CTD format.
• Clinical trial gate — Products requiring clinical studies must first obtain clinical trial permits from the CDE before initiating studies.
• Review process — The CDE conducts technical reviews, initiates verification inspections and testing, and issues comprehensive evaluation opinions. Approved products receive supplemental application approval certificates.
• Transitional rules — Unaddressed matters continue to follow the 2017 No. 100 and 2018 No. 102 announcements on consistency evaluation.

Market Impact Analysis

The phased rollout gives eye drop manufacturers immediate compliance obligations while granting patch and spray developers a roughly 10-month runway to prepare dossiers. The extension represents the final frontier of China’s decade-long generic drug quality overhaul, targeting dosage forms that have historically escaped bioequivalence scrutiny due to complex absorption profiles and limited reference standards.

For ophthalmic generics makers, the immediate launch means existing products face potential delisting if they fail to demonstrate therapeutic equivalence to reference preparations within forthcoming deadlines. The sector is fragmented among dozens of domestic producers of glaucoma, anti-inflammatory, and artificial tear formulations, suggesting consolidation pressure as smaller firms lack the R&D budgets to reformulate or conduct clinical endpoint studies.

Patch and spray manufacturers benefit from the delayed July 2027 start date but must begin reference preparation selection and formulation development now to meet what will likely be stringent pharmacokinetic or clinical efficacy requirements. The explicit permission to reference foreign regulatory standards offers a compliance shortcut for multinational subsidiaries with existing EU or U.S. approval packages, though all submissions must ultimately conform to the M4 CTD structure.

Forward-Looking Statement

Industry analysts expect the CDE to publish dedicated technical guidelines for eye drop consistency evaluation by late 2026 or early 2027, clarifying whether in vitro dissolution or clinical efficacy trials will serve as the primary equivalence benchmark. The patch and spray delay to July 2027 suggests regulators recognize the technical complexity of transdermal and pulmonary delivery systems and may use the interim period to develop specialized bioequivalence protocols. Pharmaceutical companies with portfolios spanning these dosage forms should prioritize reference preparation selection and pre-formulation studies immediately, as the supplemental application queue is likely to swell once all three categories are active. The reform aligns with Beijing’s broader industrial policy to elevate domestic generics toward global quality parity, potentially paving the way for increased export competitiveness in regulated markets.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260902093151132.html

Beijing, Sept 3, 2026 — China’s National Medical Products Administration (NMPA) and General Administration of Customs (GACC) issued Announcement No. 84 of 2026, tightening import-export declaration requirements for psychotropic substances by adding three pharmaceutical compounds to the regulated catalog and publishing customs commodity codes for cross-border shipments, effective Oct 1, 2026.

Policy Snapshot

Attribute	Detail
Issuers	NMPA; General Administration of Customs; Ministry of Public Security; National Health Commission
Document	Announcement on Declaration Requirements for Import and Export of Psychotropic Drugs (2026 No. 84)
Newly listed substances	Metomidate (excluding domestically approved formulations); an etomidate analog (excluding domestically approved formulations); solriamfetol
Effective date	Oct 1, 2026
Legal basis	Drug Administration Law; Customs Law

Key Provisions

• Expanded catalog — The NMPA, Ministry of Public Security, and National Health Commission jointly added metomidate, an etomidate analog, and solriamfetol to the medicinal psychotropic substances directory. Domestically approved formulations containing these compounds are exempted from the new controls.
• Customs codes — The announcement publishes reference customs commodity codes for the newly listed substances to facilitate import-export declarations.
• Declaration scope — The published commodity codes cover only a portion of regulated goods. Shippers must declare truthfully if actual imports or exports fall outside the specified code ranges.
• Enforcement — All cross-border movements of the listed substances must comply with the new declaration framework starting Oct 1, 2026.

Market Impact Analysis

The regulatory expansion targets new psychoactive substances and their analogs that have emerged as public health concerns, particularly etomidate derivatives that have seen misuse in non-medical settings. By exempting domestically approved formulations, regulators are drawing a sharp distinction between legitimate pharmaceutical supply chains and uncontrolled chemical flows, minimizing disruption to licensed manufacturers while closing loopholes for illicit trade.

For pharmaceutical importers and customs brokers, the Oct 1 effective date creates a narrow compliance window to update classification systems and train personnel on the new commodity codes. The explicit warning that codes cover only partial product ranges places the burden of accurate declaration squarely on traders, with misclassification risks carrying penalties under both drug control and customs regulations.

Solriamfetol’s inclusion is notable given its prior status as a prescription wakefulness agent; the new controls signal Beijing’s assessment that the compound requires stricter cross-border monitoring due to diversion potential.

Forward-Looking Statement

Industry analysts expect the NMPA to release supplementary implementation guidance before Oct 1, clarifying documentation requirements for legitimate pharmaceutical shipments and the specific exemption procedures for domestically approved formulations. Customs authorities are likely to intensify inspections of chemical and pharmaceutical cargo from key source regions starting in the fourth quarter. Trading companies and freight forwarders handling active pharmaceutical ingredients or finished psychotropic medicines should audit their commodity code databases immediately and establish verification protocols to ensure declarations capture all regulated substances, including analogs not explicitly named in the initial code list.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260902092356142.html