著者

佐藤 大作

出版者

公益財団法人 医療科学研究所

雑誌

医療と社会 (ISSN:09169202)

巻号頁・発行日

vol.32, no.1, pp.37-49, 2022-04-28 (Released:2022-05-26)

参考文献数

17

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PMDAでは,COVID-19関連の診断・治療・予防を目的とした様々な製品の審査を行っていたほか,開発早期からの企業・アカデミアからの相談に対応するなど,製品開発にも積極的に対応してきた。緊急事態下においても,様々な制約の中でリモート化などの工夫をしながら業務に遅れが出ないよう対応し,米国で2020年5月1日に緊急許可制度(EUA)で流通開始された治療薬「レムデシビル」が日本でも5月7日に特例承認された。また,医療現場での不足やニーズに対応した人工呼吸器の審査や,PCRの検査態勢の充実に対応するべく,PCR検査キット等の審査が進んでいった。また,PMDAは海外規制当局とも連携し,ワクチン評価の考え方を2020年9月2日に公表し,外国開発のワクチンの国内治験を含む国内申請準備が進んだ。米国で緊急許可されたファイザー社のワクチンの申請が2020年12月になされ,2021年2月14日に特例承認され,供給され,その後も5月に2つのワクチンが承認された。ワクチン発売後からの膨大な副反応疑い報告の受付も対応している。また,アビガン錠200mgの適応拡大の審査は,「単盲検試験」結果の臨床的意義が論点となり,2020年12月に継続審議となった。

著者

佐藤 大作

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.134, no.2, pp.213-222, 2014-02-01 (Released:2014-02-01)

参考文献数

18

被引用文献数

5 5

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Circulating counterfeit medicines in the market is a public health threat. Counterfeit medicines become common problem, not only in developing countries, but also in industrialised countries, as internet has made them more accessible. In Japan, the recent survey on the medicines purchased through on-line pharmacy (targeting Japanese consumers) showed that the majority of erectile dysfunction (ED) medicines imported by individuals in Japan were counterfeit version. The survey of Japanese consumers, who privately imported medicines through on-line pharmacy, indicated that 16% of these consumers experienced adverse events associated with these products. Not only that it is just fake brand, but fake medicines may even cause health hazard. The counterfeit version of Avastin recently detected in the United States became a serious threat for those who desperately need these medicines for life-threatening disease. The Japanese regulatory authorities have provided risk information of counterfeit medicines to general public, as well as monitored on-line pharmacies and conducted enforcement action where necessary. However, more resources of compliance activity should be allocated to respond to the situation of growing threats of counterfeit medicines. Purchasing medicines from abroad through unauthorised channel is the major source of counterfeit medicines. It is essential to prevent circulation of counterfeit medicines through international collaboration of various regulatory authorities. To address these problems, the World Health Organization (WHO) has launched a new Member States Mechanism (MSM) to build network of the authorities. Also, INTERPOL (ICPO) initiated globally concerted enforcement actions (Operation Pangea) against pharmaceutical crime as well as built partnership with pharmaceutical industry to create Pharmaceutical Crime Programme. It is also necessary to prevent consumers encountering counterfeit medicines and to prevent health hazard. The Ministry of Health, Labour and Welfare (MHLW) has been actively involved in prevention and educational activities such as public awareness campaign. MHLW started anti-counterfeit medicines and new psychoactive substance project from February 2013, which centrally collects information about counterfeit medicines, in particular, and provides the risk information more effectively to the public. Japanese Government will work together with international community and contribute to combating counterfeiting through public and private partnership.

著者

佐藤 大作

出版者

公益社団法人 日本薬学会

雑誌

YAKUGAKU ZASSHI (ISSN:00316903)

巻号頁・発行日

vol.134, no.2, pp.213-222, 2014

被引用文献数

5

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Circulating counterfeit medicines in the market is a public health threat. Counterfeit medicines become common problem, not only in developing countries, but also in industrialised countries, as internet has made them more accessible. In Japan, the recent survey on the medicines purchased through on-line pharmacy (targeting Japanese consumers) showed that the majority of erectile dysfunction (ED) medicines imported by individuals in Japan were counterfeit version. The survey of Japanese consumers, who privately imported medicines through on-line pharmacy, indicated that 16% of these consumers experienced adverse events associated with these products. Not only that it is just fake brand, but fake medicines may even cause health hazard. The counterfeit version of Avastin recently detected in the United States became a serious threat for those who desperately need these medicines for life-threatening disease. The Japanese regulatory authorities have provided risk information of counterfeit medicines to general public, as well as monitored on-line pharmacies and conducted enforcement action where necessary. However, more resources of compliance activity should be allocated to respond to the situation of growing threats of counterfeit medicines. Purchasing medicines from abroad through unauthorised channel is the major source of counterfeit medicines. It is essential to prevent circulation of counterfeit medicines through international collaboration of various regulatory authorities. To address these problems, the World Health Organization (WHO) has launched a new Member States Mechanism (MSM) to build network of the authorities. Also, INTERPOL (ICPO) initiated globally concerted enforcement actions (Operation Pangea) against pharmaceutical crime as well as built partnership with pharmaceutical industry to create Pharmaceutical Crime Programme. It is also necessary to prevent consumers encountering counterfeit medicines and to prevent health hazard. The Ministry of Health, Labour and Welfare (MHLW) has been actively involved in prevention and educational activities such as public awareness campaign. MHLW started anti-counterfeit medicines and new psychoactive substance project from February 2013, which centrally collects information about counterfeit medicines, in particular, and provides the risk information more effectively to the public. Japanese Government will work together with international community and contribute to combating counterfeiting through public and private partnership.<br>