Self Test at Home Kit in Japan_Fundamental
mogu@oggo.jp
[bogo]
Seeing a doctor online has become popular in Japan.
It will continue to grow for a while. And next to that growth, I believe there will also be growth in "self test at home kit".
This category, which is also attracting attention as an antigen test kit for Covid-19, will continue to release various products.
I'll try to write a basic overview this time.
す。
Supervision of "Self Test at Home Kit" in Japan
First, Let's classify "Self Test at Home Kit" into two categories, - one that can provide its rapid results at home, and one that provides its result through an inspection agency.
(Note: Neither is allowed to provide a diagnosis because only doctors are allowed to diagnose in Japanese law)
A test kit that provides its rapid results at home
This is a type of product in which the consumer collects a sample at home, etc., and obtains the results on the spot.
This includes urine test strips, pregnancy test kits, and antigen test kits for the new coronavirus.
This type of product is handled differently under the PMD Act. depending on the purpose of use.
Roughly speaking, it goes like this [1].
![If the product is for medical diagnosing assistance -> It's categorized in In-vitro diagnostics (IVDs)
Of these, pharmaceuticals for prescription cannot be obtained unless prescribed by a doctor in principle. (Special measures that exist as of July 2022: General consumers can purchase this at pharmacies with pharmacists[2] / General businesses can purchase this from pharmaceutical wholesalers[3].)
Of these, four types of over-the-counter medicines as test reagents have been approved. [4][5]
Urine suger, Urine protein and Pregnancy hCG -> schedule II pharmaceuticals ->pharmacists or registered sales clerks are allowed to sell at pharmacies
Luteinizing hormone（LH）->schedule I pharmaceuticals->pharmacists are allowed to sell at pharmacies
If the prodct is for other purposes -> unregulated products (include products for laboratory)](https://oggo.jp/wp-content/uploads/2022/08/image-2.png)
- If the product is for medical diagnosing assistance -> It's categorized in In-vitro diagnostics (IVDs)
- Of these, pharmaceuticals for prescription cannot be obtained unless prescribed by a doctor in principle. (Special measures that exist as of July 2022: General consumers can purchase this at pharmacies with pharmacists[2] / General businesses can purchase this from pharmaceutical wholesalers[3].)
- Of these, four types of over-the-counter medicines as test reagents have been approved. [4][5]
- Urine suger, Urine protein and Pregnancy hCG -> schedule II pharmaceuticals ->pharmacists or registered sales clerks are allowed to sell at pharmacies
- Luteinizing hormone（LH）->schedule I pharmaceuticals->pharmacists are allowed to sell at pharmacies
- If the prodct is for other purposes -> unregulated products (include products for laboratory)
If it falls under in-vitro diagnostics, permission and approval procedures based on the PMD Act. are required. Although it takes time and effort, quality is ensured through the approval procedures, and there is also the possibility of Japanese insurance reimbursement.
If the product is categorized as unregulated products, the quality is guaranteed only by the manufacturer.
Due to this quality guarantee, that is, the reliability of the results, the Ministry of Health, Labor and Welfare has enlightened to use "medical use (= in-vitro diagnostic drug)" not "research use (= unregulated products)" for self-checks regarding the new coronavirus.[5]
Some in-vitro diagnostics contain medical devices (lancets, dissectors, cotton swabs, etc.) to collect specimens.
It seems that many of those products are applying for approval as "combination products" that combine pharmaceutical and medical devices.
A test kit that provides its results through an inspection agency
This is a type of product in which the consumer collects a sample at home, etc., and sends the sample to an inspection agency for detection.
This includes Inspection service by mail, PCR test kit.
Medical devices (lancets, dissectors, cotton swabs, etc.) may be used to collect specimens.
Points to keep in mind when doing business with home test kits/services
Regarding home test kits, as mentioned above, the PMD Act is one point, but there is another important point. It is Medical Practitioners' Act.
The Law says "No person except a medical practitioner may engage in medical practice." in article 17.
It is no exaggeration to say that whether or not home test kits/services conflict with this Law is the most important point in doing business.
(Although I could not confirm the description in the clear text, as far as I can see the notifications issued by the Ministry of Health, Labor and Welfare, I believe that "diagnosis and treatment" is currently considered to be a work permitted only to doctors.)
Oggo.jp
As I mentioned at the beginning, I believe that various test kits/services will appear on the market in the future.
The Japanese government also expects this market to expand in the future, and is trying to create appropriate regulations[6].
Companies that want to do business in this field need to carefully consider how to develop their products/services within the legal restrictions.
If this point is left vague, the product may not be able to clear customs in the first place.
Oggo.jp supports companies that want to do business in the healthcare field, so if you have any problems, please feel free to contact Oggo.jp.
References
- 「体外診断用医薬品の取扱いに関する質疑応答集について」平成23年9月6日 薬食機発0906第1号. https://www.pmda.go.jp/files/000159238.pdf. （2022−07−27閲覧）
- 「新型コロナウイルス感染症流行下における薬局での医療用抗原定性検査キットの取扱いについて」令和3年9月27日 厚生労働省厚生労働省新型コロナウイルス感染症対策推進本部 厚生労働省医薬・生活衛生局総務課 事務連絡. https://www.mhlw.go.jp/content/000836277.pdf.（2022−07−28閲覧）
- 「一般事業者からの問合せに対応できる医薬品卸売業者等について（ワクチン・検査パッケージ制度）」.厚生労働省.（更新日不明）.https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000121431_00296.html. （2022−08−02閲覧）
- 「体外診断用医薬品の一般用検査薬への転用について」平成26年12月25日 薬食発1225第1号. https://www.pmda.go.jp/files/000203308.pdf.（2022−07−28閲覧）
- 「新型コロナウイルス感染症の研究用抗原定性検査キットの販売に関する留意事項について」令和4年5月2日厚生労働省新型コロナウイルス感染症対策推進本部 厚生労働省医薬・生活衛生局監視指導・麻薬対策課 事務連絡. https://www.mhlw.go.jp/content/000935681.pdf（2022−07−28閲覧）
- ”2022年４月11日 薬事・食品衛生審議会 医療機器・体外診断薬部会 議事録".（更新日不明）. https://www.mhlw.go.jp/stf/newpage_27045.html.（2022−07−28閲覧）
お気軽にご相談ください。
・初回相談は無料です。
・行政書士には秘密保持の義務が課せられております。
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![疾病の診断（を補助すること）が目的である→体外診断用医薬品
うち、医療用医薬品は、原則お医者さんに処方されないと入手できない。（COVID-19抗原検査キットを個人が薬剤師のいる薬局で購入できる[2]、一般事業者が医薬品卸売業者から購入できる[3]のは特例措置。）
一般用検査薬は現在4種類承認がある。[4][5]
尿糖、尿蛋白及び妊娠検査薬→第二類医薬品に分類→薬剤師または登録販売者が販売対応
尿中黄体形成ホルモン（LH）→第一類医薬品に分類→薬剤師が販売対応
疾病の診断（を補助すること）が目的ではない→雑品（研究用試薬を含む）](https://oggo.jp/wp-content/uploads/2022/08/image.png)
