Current Status and Challenges of Manjaro Importation: Precautions for Personal Importation of Overseas Pharmaceuticals | TASAKI PHAMA

Domestic Supply Status of Mounjaro

In recent years, Mounjaro (generic name: Tirzepatide), a type 2 diabetes treatment drug, has been widely used in medical settings due to its high blood glucose control and weight loss effects. However, due to increased domestic demand and fluctuations in the global supply chain, temporary shortages and supply delays have been observed.

Under these circumstances, patients and healthcare professionals are increasingly interested in importing overseas versions of Mounjaro and other formulations containing Tirzepatide as an active ingredient (e.g., Zepbound, approved in the United States). However, the personal import of pharmaceuticals from overseas involves various points to note, such as quality, safety, and legal regulations.

Risks of Overseas Versions of Mounjaro and Personal Importation

Mounjaro is approved and sold in many countries, including the United States. However, when personally importing overseas versions of Mounjaro, the following risks should be considered:

• Quality and Safety: Personally imported pharmaceuticals may not meet the quality standards based on the Japanese Pharmaceuticals and Medical Devices Act. There is a possibility of counterfeits or inferior products.
• Side Effects: Clinical trial data on overseas versions of Mounjaro may not be sufficient for Japanese individuals. There is a risk of unexpected side effects.
• Package Insert: The package insert for overseas versions of Mounjaro may not be written in Japanese. It may not be possible to accurately understand information on dosage and side effects.
• Storage and Transportation: Mounjaro must be stored and transported under appropriate temperature control (cold chain). In the case of personal importation, temperature control during transportation may be insufficient, which may deteriorate the quality of the drug.
• Customs: Depending on the type and quantity of pharmaceuticals to be personally imported, customs may stop the import.

Considering these risks, it is not recommended to easily import overseas versions of Mounjaro personally. It is important to use appropriate pharmaceuticals under the guidance of a doctor.

Points to Note When Using a Personal Import Agency

Some malicious personal import agencies sell illegal pharmaceuticals or charge unreasonable prices. When using a personal import agency, the following points should be noted:

• Check the reliability of the agency (location, contact information, permission status, etc.)
• Check whether the price of the pharmaceutical is appropriate
• Check the conditions for quality assurance and returns/exchanges of pharmaceuticals
• Consult a doctor or pharmacist and follow their instructions

Overseas Situation of Tirzepatide Preparations: Mounjaro and Zepbound

Tirzepatide is a new type 2 diabetes treatment drug with a novel mechanism of action that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptors. In the United States, Eli Lilly and Company has obtained FDA (U.S. Food and Drug Administration) approval for Mounjaro as a type 2 diabetes treatment drug and Zepbound as an obesity treatment drug.

Zepbound contains the same active ingredient as Mounjaro, Tirzepatide, but has different indications and dosages. Zepbound is used in conjunction with diet and exercise therapy for obese patients with a BMI of 30 or higher, or overweight patients with a BMI of 27 or higher and complications such as hypertension, type 2 diabetes, or dyslipidemia.

In Europe, the EMA (European Medicines Agency) has approved Mounjaro as a type 2 diabetes treatment drug. Zepbound is currently under review.

Based on these overseas situations, when considering the personal import of Tirzepatide preparations, it is necessary to fully understand the indications, dosages, and side effects of each drug and make a decision under the guidance of a doctor.

Points to Note and Legal Regulations Regarding Personal Import of Pharmaceuticals from Overseas

The personal import of pharmaceuticals is, in principle, permitted only when necessary for the treatment of one’s own illness. Sale or transfer to others is prohibited. In addition, there are restrictions on the quantity that can be imported, and permission is required if the quantity exceeds the range specified by the Ministry of Health, Labour and Welfare.

Laws and regulations regarding the personal import of pharmaceuticals vary by country and region. In Japan, it is regulated by the Pharmaceuticals and Medical Devices Act (formerly the Pharmaceutical Affairs Law). When personally importing pharmaceuticals, it is necessary to comply with these laws and regulations.

The Ministry of Health, Labour and Welfare is issuing warnings regarding the personal import of pharmaceuticals and calls for attention to the following points:

• If health damage occurs due to personally imported pharmaceuticals, it will not be covered by the Pharmaceutical Side Effects Relief System.
• It is desirable to receive guidance from a doctor or pharmacist when using personally imported pharmaceuticals.
• Care is required because some personal import agencies are illegal.

The personal import of pharmaceuticals must be done at one’s own risk. It is important to fully understand the risks and make a careful decision.

Summary

The personal import of overseas pharmaceuticals, including Mounjaro, may seem attractive considering the domestic supply situation and prices. However, there are various risks such as quality, safety, and legal regulations. When personally importing, it is necessary to fully understand these risks and make a careful decision, such as consulting a doctor or pharmacist. In addition, regarding Tirzepatide preparations, attention should be paid as indications and dosages may differ, such as with Mounjaro and Zepbound. Pharmaceuticals directly affect our health. It is important to prioritize safety and make decisions based on appropriate information.