For years, pharmaceutical companies have faced multiple policy barriers when seeking hospital sales approval after product launches. Medical institutions must carefully evaluate which hospitals will receive limited quotas and opportunities due to rigorous performance evaluations. Key factors influencing this decision include inclusion in essential drug lists, participation in national medical insurance programs, outcomes of national and provincial centralized procurement processes, and restrictions on the quantity of drugs available for use in medical facilities.
In recent years, policy-making has become increasingly centralized. Many policies are rolled out through a top-down cascade, where high-level directives and frameworks are first established before being communicated and implemented at lower levels. This explains why policymakers must first examine national policies before considering provincial regulations and local implementation details – otherwise, it would create a chain of disconnected steps.
National policy updates: In October 2021, China removed quantity restrictions for essential medicines in the "Basic Drug Supply Catalog". By November 2024, medical consortiums will be allowed to determine essential drug inventories as unified entities. Medications for hypertension, diabetes, and chronic obstructive pulmonary disease (COPD) will no longer be subject to the "one drug, two specifications" rule. Furthermore, hospital admission restrictions shall not be imposed due to total medical insurance budget constraints, existing drug catalog quotas, or medication cost-to-revenue ratios. In essence, healthcare institutions are gradually being allowed greater flexibility in their drug selection processes.
Beijing: The restriction on the number of drugs in medical institutions will be abolished in April 2024. The pharmaceutical council will be promoted to standardize the drug affairs, and the pharmaceutical council will be held within one month after the publication of the national negotiation list, with no less than four times a year.
Shanghai: In December 2024, there will be no limit on the number of drug varieties in hospitals at all levels
Shandong Province: In June 2024, Jinan City abolished quantity restrictions on pharmaceuticals in medical institutions. Healthcare facilities will determine appropriate drug varieties and quantities based on their functional positioning and service capabilities. The province is promoting standardized and institutionalized pharmaceutical affairs committees, requiring these committees to convene within one month after the national negotiated drug list is published, with no fewer than four annual meetings. By March 2025, Shandong Province will implement a policy allowing hospitals to rationally determine the use of innovative drugs without being restricted by the total quantity limits of essential medications in their internal drug inventories.
Guangdong: In July 2023, the previous 2012 regulations limiting drug varieties in medical institutions were abolished. The original requirements stipulated that "tertiary general hospitals should not exceed 1,500 varieties, tertiary specialized hospitals 1,200, secondary general hospitals 1,000, secondary specialized hospitals 800, and other medical institutions 600". In September 2024, Guangzhou implemented the removal of total drug variety restrictions for medical institutions. Medical institutions are now required to hold at least one quarterly meeting each for the Pharmaceutical Affairs Management Committee, Therapeutics Committee, and Medical Device Committee. Additionally, meetings must be convened within three months after the official release of the new National Medical Insurance Drug List and within one month after the publication of Guangzhou's Innovative Drug and Medical Device Catalog. This ensures timely inclusion of nationally negotiated drugs and innovative medications into institutional drug/research equipment catalogs, achieving full coverage and prioritized selection based on clinical needs.
Sichuan: The national "Implementation Rules for the Three-Level General Hospital Evaluation Standards (2011 Edition)" was abolished on October 9, 2021, and its requirements regarding the number of specifications in the "Basic Drug Supply Catalog" for medical institutions are no longer enforced. Medical institutions must establish and improve pediatric medication selection systems to ensure proper management of pediatric drug allocation. When selecting pediatric medications (limited to those with clear pediatric indications and dosages specified in the drug instructions), they may bypass the "one product, two specifications" rule and total drug variety restrictions, thereby expanding access to pediatric medications.
Xinjiang: The national "Implementation Rules for the Three-Level General Hospital Evaluation Standards (2011 Edition)" was abolished on October 9, 2021. This revision removed the requirement for medical institutions to maintain a fixed number of drug specifications in their "Basic Drug Supply Catalog" as an evaluation criterion. All levels of medical institutions must eliminate restrictions on the quantity and types of drugs admitted into hospitals. Strengthen management of pediatric medication allocation and usage. Medical institutions should establish comprehensive selection systems for pediatric drugs and improve their distribution management. When selecting pediatric medications (limited to those with clear pediatric indications and dosages specified in drug instructions), institutions may bypass the "one product, two specifications" policy and total drug variety limits, thereby expanding access to pediatric medications.
Fujian Province: By August 2025, medical institutions will be exempt from restrictions on the total number of drug varieties they can prescribe. They will be permitted to use innovative pharmaceuticals, advanced medical devices, and traditional Chinese medicine products as specified. Drugs with identical generic names must adhere to the "one product, two specifications" principle, except in cases involving special populations requiring alternative formulations or dosages for specific medical needs, or when higher-level regulations explicitly permit exceptions to this rule.
In addition to the limit on the number of drugs, provinces have also added some humanistic regulations on the use of drugs for special groups, such as children's drugs and drugs for special groups.
Jiangsu Province: In November 2022, enhanced drug safety management for pediatric patients was implemented. Considering children's incomplete physical development, immature organ functions and immune systems, as well as faster drug absorption and metabolism compared to adults, healthcare providers are advised to select medications with high safety profiles and minimal side effects when determining treatment options. This approach allows reasonable expansion of medication use based on patients' physical conditions, body measurements, and age factors, without being restricted by the "one product, two specifications" policy or total drug variety limits.
Zhejiang: In January 2023, when selecting drugs for children (only those drugs with clear indications for children and dosage for children in the drug instructions), the "one product, two rules" and the total number of drugs are not subject to the restrictions.
Hunan: In April 2024, in accordance with the relevant provisions of "one product and two regulations", drugs that are clinically needed, have definite curative effect and good safety will be selected. The use of drugs for children and other special groups will not be restricted by "one product and two regulations".
Hebei Province: In September 2024, the clinical rational use of negotiated drugs shall not be affected by any reasons such as total medical insurance control, drug cost ratio, average per-case expenses, DRG/DIP payment reform, restrictions on drug list varieties, or pharmaceutical committee reviews. Except for antibiotics, the quantity of negotiated drugs used rationally shall not be restricted by assessments or evaluations.
Jiangxi: In August 2024, pediatric medications (those explicitly indicated for children with clear dosage instructions in drug labels) will be exempt from the "One Product, Two Specifications" restriction, further expanding pediatric medication coverage. National medical insurance negotiated drugs and nationally/provincially centralized procurement selected varieties will also be exempt from specification restrictions.
Tianjin: In December 2024, medical institutions shall not restrict the admission of innovative drugs due to the number of drug catalogs or the proportion of drugs.
In summary, while restrictions on drug varieties used in medical institutions are gradually being relaxed, healthcare providers still maintain their own strategic priorities. They must fulfill obligations such as meeting the volume requirements for centrally procured selected products, passing essential drug assessments, and implementing the DRG/DIP (Diagnosis-Related Groups/Targeted Incentive Payments) system. With limited market capacity, increased competition inevitably leads to reduced availability for others. As approval numbers continue to rise, competition in drug access processes will intensify. Ultimately, success will depend on a company's comprehensive capabilities.
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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