While major policy frameworks exist, many aspects of the innovative drug supply chain remain unimplemented. Take the first-in-class pricing policy as an example: although a draft proposal was released early last year, it underwent revisions due to significant public skepticism and has since been largely undisclosed.
At the beginning of this year, the document of the State Office reiterated that we should actively support the promotion and use of innovative drugs, study and trial self-evaluation of newly marketed drugs based on pharmaceutical and clinical value, and optimize the service of listing newly marketed drugs.
More than half a year has passed, yet the National Healthcare Security Administration (NHSA) still hasn't officially released its comprehensive plan. With the central government failing to provide reassurance, provincial authorities are compelled to formulate their own online listing policies based on consensus. As a result, initial implementation measures can only be replicated or vaguely addressed, essentially continuing the existing provincial-level approaches.
In January this year, Guangdong Province released its approved catalog of innovative biopharmaceutical products, promoting their hospital application through the "maximizing allocation" principle. This policy essentially constitutes a local protection mechanism. From a national policy perspective, Guangdong had long been the first to implement such measures nationwide. The revised online listing regulations following this consensus were officially implemented on September 1.
Zhejiang Province has optimized its online registration mechanism for innovative drugs and medical devices by improving the green channel system, ensuring full-process processing within 15 working days. The province is actively seeking provincial pilot programs for initial pricing acceptance of newly launched drugs and exploring mechanisms to determine pricing for newly approved chemical drugs. For new drug launches, enterprises are encouraged to maintain autonomous pricing, supporting qualified innovative drugs to achieve returns commensurate with their high-investment and high-risk nature during market entry. In reality, innovative drugs haven't yet delivered substantial benefits in Zhejiang. Previously, companies could negotiate prices online first and then complete price adjustments across 10 provinces. The new regulation now requires coordination across five provinces, though whether there's a transitional period remains uncertain.
Shandong Province has accelerated its online drug listing and deployment: It will timely release a catalog of innovative pharmaceutical products in Shandong. Pharmaceutical manufacturers are instructed to initiate online listing procedures simultaneously after the catalog's publication, with reasonable pricing formulation and optimized policies including a first-order procurement green channel. For clinically essential innovative drugs not yet listed, offline emergency procurement is permitted. However, Shandong's supportive policies appear to focus on local protection rather than comprehensive support. Whether "first-order listing" and "first-order procurement" are the same concept remains unclear, as official explanations are rarely made public. Provincial enterprises might have better understanding of these nuances.
Sichuan Province has accelerated the direct hospital access for innovative drugs. The supported innovative drugs include Category 1.1 new chemical drugs before the implementation of the new registration classification, Category 1 drugs after implementation, Category 1 therapeutic biological products, and Category 1 traditional Chinese medicine and natural medicines. The Provincial Medical Insurance Bureau has optimized service procedures for newly launched innovative drugs by implementing centralized bulk procurement, price-linked procurement, and filing procurement systems. Eligible innovative drugs can now be submitted at any time with self-determined pricing and direct online listing, completing review within 15 working days to enhance listing efficiency. Municipalities (prefectures) have formulated hospital access process guidelines tailored to local conditions. However, in practice, Sichuan's drug classification code import alone took over a month, ranking last nationwide in processing speed.
In early July, the National Healthcare Security Administration and National Health Commission released the "Several Measures to Support High-Quality Development of Innovative Drugs," which further clarified optimized drug listing procedures. Pharmaceutical companies can independently select provinces for initial acceptance of innovative drugs, conduct tiered evaluations, set prices autonomously, and handle acceptance procedures in compliance with regulations while assuming corresponding responsibilities. Drugs included in national medical insurance catalogs and commercial insurance directories can be directly listed online, featuring streamlined application processes, simplified requirements, shortened timelines, and rapid inter-provincial coordination. Provincial centralized procurement agencies are required to enhance listing efficiency according to the principle of "efficiently completing one task." However, specific provinces qualified for initial acceptance remain undefined.
In August, the Jiangsu Provincial Government Office issued a notice on comprehensive measures to advance pharmaceutical and medical device regulation reforms and promote high-quality development of the pharmaceutical industry. The policy supports innovative product promotion through: establishing a green channel for online registration of innovative drugs with year-round availability and immediate submission processing. Applications will be finalized within 15 working days after acceptance. Intellectual property dispute resolution mechanisms for innovative drugs and medical devices will be enhanced to facilitate early conflict resolution. The policy encourages first-purchase incentives for self-developed innovative products. After submitting an innovative drug application, companies can immediately consult with medical security and health authorities to prepare for medical insurance approval and hospitalization use in advance.
Jiangsu has both declared and implemented these principles. In Class 1 innovative drugs, Jiangsu and Liaoning can take the lead without being bound by out-of-province pricing standards, boldly pioneering industry initiatives. Hainan Province has proposed accelerating the transformation and application of innovative products: releasing a catalog of innovative pharmaceuticals and medical devices, expediting their online registration and hospital adoption, while facilitating product launches and hospital-enterprise partnerships.
Tracking the online registration progress of certain new drug categories shows that about half of provinces can achieve this within three months. Products approved through BiPu's evaluation process tend to pass reviews faster, with at least some initial registration provinces facing lower challenges. However, the approval speed for special categories like those requiring national negotiations is comparable. The main obstacles lie in initial provincial waiting periods and slow updates to the comprehensive registration list, forcing some provinces to repeatedly submit applications. This complicates what should be straightforward processes. Additionally, price discrimination exists in certain provinces like Guangdong and Shanghai. Although Shanghai's system provides guaranteed pricing for innovative drugs, many other provinces only recognize restricted pricing. Furthermore, progress varies significantly across provinces regarding multi-specification applications. Some provinces still require actual transactions, while newly launched drugs must wait for national negotiations to gain real momentum – making early development challenging. For companies unwilling to invest heavily, waiting for national negotiations to materialize becomes the only viable option.
The current reality remains that the success of innovative drugs still hinges on the outcomes of national drug negotiations, as independent pricing strategies in earlier stages hold limited significance. Unless future first-in-class drug pricing becomes more closely tied to negotiated prices. As pharmaceutical companies, they can only quietly monitor developments and await more supportive policies for innovative therapies.
Disclaimer: This article is only for the purpose of knowledge exchange and sharing, and does not involve commercial publicity, and does not serve as relevant medical guidance or medication advice. If there is any infringement, please contact us for deletion.
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