What Is the Process for Innovative Drugs to Enter Hospitals in China? A Complete Guide from Approval to Clinical Use

In recent years, China’s innovative drug development has entered a period of rapid growth, with an increasing number of cancer therapies, bispecific antibodies, ADC drugs, and CAR-T therapies being approved for marketing.

However, a common misconception is that once a drug is approved, it can immediately enter hospitals and be used by patients.

In reality, in China, innovative drugs must go through multiple key steps from regulatory approval to actual hospital access and clinical use. Hospital access is one of the most critical stages in the commercialization of innovative drugs.

Hong Kong-based DengYueMed provides a detailed overview of the complete process for innovative drugs entering hospitals in China.

Step 1: Approval by the National Medical Products Administration (NMPA)

The starting point for any innovative drug entering the Chinese market is obtaining marketing authorization from the National Medical Products Administration (NMPA).

After completing clinical trials and submitting a New Drug Application, pharmaceutical companies must undergo a comprehensive regulatory review of safety, efficacy, and quality. Once approved, the drug is legally allowed to be marketed in China.

However, NMPA approval only means the drug is eligible for market entry—it does not mean hospitals can automatically purchase or use it.

Therefore, NMPA approval is considered the starting point of commercialization, not the end.

Step 2: Provincial Centralized Drug Procurement Listing

In China, most public hospitals procure drugs through provincial centralized procurement platforms.

After approval, companies must complete provincial centralized procurement listing and upload product information into the official provincial procurement systems.

Listing information typically includes:

● Drug name

● Dosage form and packaging

● Manufacturer

● Listed price or winning bid price

● Supply assurance information

Only after completing the provincial listing process can hospitals legally procure the drug through official procurement platforms.

For nationwide commercialization, companies usually need to complete listing across multiple provinces in a step-by-step manner.

Step 3: Hospital Pharmacy & Therapeutics Committee Review

The Pharmacy and Therapeutics Committee (P&T Committee) is one of the most critical stages for hospital entry.

Hospitals do not automatically include a drug simply because it has been approved. Instead, internal review procedures are required.

The committee typically evaluates the following factors:

1. Clinical Value

Does the drug address an unmet clinical need?

Does it offer significant advantages over existing therapies?

2. Safety

Are there serious adverse event risks?

Is there sufficient real-world evidence?

3. Guideline Recommendations

Is the drug included in major clinical guidelines such as:

● NCCN Guidelines

● CSCO Guidelines

● ESMO Guidelines

4. Pharmacoeconomic Value

Is the price reasonable?

Do the cost and clinical benefits align?

5. Hospital Demand

Does the hospital have the relevant patient population?

Do relevant departments require this therapy?

Only after passing the P&T review can a drug be considered for inclusion in the hospital formulary.

Step 4: Inclusion in the Hospital Drug Formulary

After approval, the drug will be added to the hospital’s internal formulary.

Since hospitals have limited formulary slots, new drugs often need to compete with existing therapies.

In oncology, autoimmune diseases, and rare diseases, hospitals generally prioritize:

● Drugs with strong clinical evidence

● Guideline-recommended therapies

● Reimbursed (insurance-covered) drugs

● Products with strong physician recognition

Therefore, even breakthrough innovative drugs may face a relatively long access timeline.

Step 5: Hospital Procurement and Inventory Management

Once included in the formulary, hospital pharmacy departments develop procurement plans.

Key considerations include:

● Estimated patient volume

● Department demand

● Budget allocation

● Supply stability

For CAR-T therapies, high-cost oncology drugs, and certain rare disease treatments, hospitals may adopt on-demand procurement models to reduce inventory risks.

Step 6: Physician Prescription and Clinical Adoption

Being listed in a hospital does not necessarily lead to rapid sales growth.

Physician adoption is a key driver of real-world market performance.

Factors influencing prescribing behavior include:

● Clinical trial evidence

● Expert consensus

● Academic conference promotion

● Real-world data

● Patient affordability

Many innovative drugs, even after entering hospitals, may experience slow uptake due to limited physician familiarity or experience.

Step 7: Inclusion in the National Reimbursement Drug List (NRDL)

For most innovative drugs, reimbursement access is a key step in expanding patient accessibility.

After inclusion in the NRDL:

● Patient out-of-pocket costs are significantly reduced

● Hospitals are more willing to adopt the drug

● Physicians are more likely to prescribe it

● Market scale expands rapidly

In recent years, multiple domestic PD-1 inhibitors, targeted therapies, and rare disease drugs have achieved strong sales growth following NRDL negotiations.

Therefore, reimbursement access is widely regarded as a major milestone in pharmaceutical commercialization.

Why Is Hospital Access So Important?

In the Chinese market, drug approval does not equal commercial success.

Many drugs face their biggest challenges not in R&D, but in market access.

From NMPA approval to hospital procurement, multiple layers are involved, including regulatory listing, P&T review, formulary inclusion, and reimbursement negotiation.

For pharmaceutical companies, hospital access capability often determines the commercial success of a product.

Conclusion

With the continuous development of China’s innovative pharmaceutical industry, more globally competitive therapies are entering the market. However, regulatory approval is only the beginning of commercialization.

From approval to patient access, innovative drugs must go through provincial listing, hospital review, formulary inclusion, procurement management, and reimbursement negotiations.

For overseas pharmaceutical companies, importers, distributors, and investors, a clear understanding of China’s hospital access system is essential for accurately assessing market potential and commercialization prospects.

China pharmaceutical wholesaler DengYueMed has long been engaged in the supply and distribution of innovative drugs in oncology, rare diseases, and chronic diseases, providing pharmaceutical wholesale and cross-border distribution cooperation services, supporting multi-level market accessibility and stable drug supply needs.