Current Status and Challenges of Saline Solution Import | Measures Against Shortage of Saline Solution for Drug Dissolution | TASAKI PHAMA

Introduction: Current Shortage of Saline Solution for Drug Dissolution

In recent years, an unprecedented situation has arisen in the medical field: a shortage of saline solution for dissolving drugs. Saline solution is essential, especially in the preparation of drugs for advanced medical treatments such as chemotherapy. It is used to dissolve and dilute drugs to administer them to patients at the appropriate concentration. This shortage can have a serious impact on daily healthcare delivery.

The shortage of 500ml saline solution preparations is particularly problematic. This volume is used in a wide range of applications, including dissolving and diluting multiple drugs and administering intravenous infusions, resulting in concentrated demand. Although larger volume saline solution preparations can be used as substitutes, they require subdivision in a sterile environment, increasing the burden on healthcare professionals and raising concerns about contamination risks.

In this situation, importing saline solution from overseas is an important option to address the supply shortage. However, the import of saline solution presents various challenges, including quality, safety, legal regulations, and logistics costs. This article provides a detailed explanation of the legal considerations and logistics costs associated with importing saline solution for drug dissolution.

Legal Considerations for Importing Saline Solution

When importing saline solution, it is necessary to comply with various laws and regulations, including the Act on Pharmaceuticals and Medical Devices (PMD Act). The main legal considerations are outlined below.

Act on Pharmaceuticals and Medical Devices (PMD Act)

Saline solution falls under the category of pharmaceuticals under the PMD Act. Therefore, permission or approval from the Minister of Health, Labour and Welfare is required for import. Specifically, the following procedures are necessary:

• Marketing Authorization Holder (MAH) License: Businesses that sell pharmaceuticals in Japan must obtain a Marketing Authorization Holder (MAH) license.
• Manufacturing License: Overseas manufacturers must obtain a license equivalent to the Japanese manufacturing license.
• Approval/Certification for Each Product: Approval or certification from the Minister of Health, Labour and Welfare is required for each type of saline solution to be imported.

These procedures are very complex and require specialized knowledge. Pharmaceutical trading companies like us can handle these procedures on your behalf, supporting smooth import processes.

Customs Law

Customs duties may be imposed when importing saline solution. The tariff rate varies depending on the country of origin and the type of product. In addition to customs duties, taxes such as consumption tax and local consumption tax may also be imposed.

Other Relevant Laws and Regulations

In addition to the above, it is necessary to comply with relevant laws and regulations such as the Food Sanitation Act, the Plant Protection Act, and the Act on Domestic Animal Infectious Diseases Control, depending on the type and intended use of the saline solution to be imported.

For example, if the saline solution contains specific additives, it may be subject to the regulations of the Food Sanitation Act. Also, if it contains ingredients of animal origin, it may be subject to the regulations of the Act on Domestic Animal Infectious Diseases Control.

In order to comply with these regulations, it is important to collect detailed information on the ingredients and manufacturing methods of the saline solution to be imported and consult with experts (lawyers, administrative scriveners, etc.).

Even if saline solution is approved by public institutions such as the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency), import may not be permitted if it does not comply with Japanese regulations. Special attention should be paid to standards regarding additives and manufacturing methods, as they vary from country to country.

Logistics Costs for Importing Saline Solution

When importing saline solution, various logistics costs are incurred in addition to the product price. The main logistics costs are outlined below.

Transportation Costs

These are the costs of transporting saline solution from overseas to Japan. Transportation methods include ocean freight, air freight, and international courier services. Costs vary greatly depending on the transportation distance, volume, and method. Generally, ocean freight is suitable for large-volume transportation but takes time. Air freight is suitable for urgent cases but is more expensive.

Insurance Premiums

This is the cost of insuring cargo against accidents or disasters during transportation. The insurance premium varies depending on the type of cargo, amount, and transportation method.

Customs Clearance Fees

These are the costs associated with import procedures at customs. If you have a customs broker handle the procedures, a handling fee will be charged.

Storage Costs

This is the cost of storing the imported saline solution in a warehouse. The cost varies depending on the storage period, location, and conditions. Saline solution may require temperature control, so it is necessary to choose an appropriate storage location.

Other Costs

In addition to the above, inspection costs, packaging costs, and labeling costs may be incurred. Also, depending on the type of saline solution to be imported, special transport containers or packaging materials may be required.

In order to accurately grasp these logistics costs, it is important to obtain quotes from multiple vendors and compare them. Also, pharmaceutical trading companies like us can leverage logistics networks to support cost-effective imports.

For example, if there is a shortage of saline solution used to dissolve anti-cancer drugs, rapid import is required. Immune checkpoint inhibitors such as Pembrolizumab and Nivolumab are used to treat various types of cancer (lung cancer, gastric cancer, malignant melanoma, etc.), and saline solution is essential for the preparation of these drugs. If the supply is disrupted, it may affect the patient’s treatment schedule.

Conclusion: Towards Stabilizing the Supply of Saline Solution

The shortage of saline solution for drug dissolution is a serious problem in the medical field, and in order to solve it, in addition to stabilizing domestic production, import from overseas is an important option. However, the import of saline solution presents various challenges, including legal regulations and logistics costs. In order to overcome these challenges and build a stable supply system, it is necessary for medical institutions, pharmaceutical manufacturers, trading companies, and government agencies to cooperate and take comprehensive measures.

In particular, deregulation and simplification of import procedures are essential to promote imports. Also, in order to reduce logistics costs, it is effective to optimize transportation methods and implement joint transportation initiatives. Furthermore, thorough quality control is also important. In order to ensure the quality of imported saline solution, it is necessary to rigorously evaluate the quality control system of the manufacturer and, if necessary, conduct quality inspections by a third-party organization.

Saline solution is an essential pharmaceutical product in the medical field, and its stable supply is extremely important for protecting the health and safety of patients. We will continue to monitor the supply situation of saline solution and take appropriate measures as necessary.