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【MHLW】Publishing a list of drugs requiring stability protection‐506 items such as Cefazolin

2021年03月09日 (火)

On February 26, the Ministry of Health, Labor and Welfare (MHLW) announced 506 items in its proposal about “Ensuring the Stability of Medical Products”, containing a list of medical drugs requiring stability protection. By category, 21 items such as Cefazolin sodium, which had supply problems, were listed that should be dealt with the highest priority, and 29 items such as Busulfan were listed that should be dealt with priority.

By component, 216 items for internal use, 244 items for injection, and 46 items for external use, for a total of 506 items, were shown as drugs requiring stability protection.

By category according to priority, 21 items such as Cefazolin sodium (Cefazolin sodium hydrate), Cyclosporine, Adrenaline, and Acetaminophen (rectal) were listed that should be dealt with the highest priority.

Meanwhile, 29 items such as Hydroxychloroquine sulfate, Busulfan, Daratumumab (genetically modified), and Diazepam (rectal) were listed that should be dealt with priority. Other 456 items such as Acetaminophen, Dexamethasone, and Midazolam were also included as other drugs requiring stability protection.

As a result of initial discussions at MHLW, “Meeting on measures to ensure the stability of medical drugs by related parties” in March last year, 551 items were selected. However, further discussion by detailing the categories, reduced the total into 506 items.

The MHLW is expected to gather opinions for proposal regarding the stability of medical products until the 12th and then conclude it within this year.


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