Import of safety and international criticism of vaccine for focus "Large-scale side" new full Dipterocarpus tuberculatus of "Exception approval" to the first application

The import from foreign countries of the vaccine for a new influenza has rapidly worn reality. A necessary vaccine is declared to be "For 53 million" domestically as Health Minister Yoichi Masuzoe renews, and the idea of covering an insufficient amount by the import in a domestic manufacturing is stressed. In addition, even the outlook that applied "Exception approval" on an omissible pharmaceutical Affiars Law for the first time showed a domestic clinical test (trial) to the import vaccine contingent on approval in foreign countries. It is possible to exchange or -.  an international criticism to the import Japan of developed countries problem Hanai in the safety of the import vaccine

- One year from half a year

Approval in the country based on the pharmaceutical Affiars Law is needed to circulate the medicine domestically. It is necessary to pass the trial domestically to obtain approval and to pass the review by the country on the implementation lingua. However, the period of one year from half a year is required even if it is short, and it is not in time for approval at all in a real fashion in the country of a new influenza as usual when stepping on this procedure.

Then, having surfaced is application of the exception approval. HIV (aids virus) infection problem by the unheated blood product before was founded to supply the medicine that had to be used in the emergency to the lesson promptly as for this system in 1996. However, it has been applied up to now and it never exists with the calositas.

The emergency import of the vaccine has the example in the past. The blanket operation lingua of the live vaccine in the emergency import and 13 million infants from the former Soviet Union and Canada because the poliomyelitis (infant paralysis) greatly goes around in 60, and the live vaccine had not been authorized at this time domestically in 61. A supralegal countermeasure before the exception approval was able to be done.

- Different type

The vaccine for the new influenza that four companies of the country are manufacturing need not newly receive approval in the country for the same manufacturing method as the vaccine for the seasonality influenza used every year.

On the other hand, the type is different as the material that reinforces the immunity that is called "Adjuvant" has been added as for an overseas vaccine from the vaccine in Japan though the government is advancing the negotiation with plural overseas manufacturers.

 ｢At least, data ..what one the vaccine is.. is useless in case of not being. It is approved in foreign countries it is not recommended by the person in 'Safe perhaps' domestically though it thinks the effect to be if it tries to inoculate it widely. ｣

The center head specifies it so Okabe Nobuhiko of the National Institute of Infectious Diseases infectious disease information center also who is the member of the council of the specialist of the new influenza task force of the government (and Hiko Nobu).

Similarly, as "One's personal observation" and a condition that imports the vaccine though it refuses in a skill practice from which chairman Shigeru Omi of the council (It sees and grow thick) was opened in Tokyo on the 20th｢The one only to do the clarification to safety might be necessary. There may be even a judgment of not using it when understanding if safety is not good. ｣The view is shown.

 - "Regrettable impression"

Running short internationally at first is inevitable though the supply of the vaccine starts in September in an early point in foreign countries. There is a criticism in the import of Japan where there are abundantly possession of the vaccine manufacturer of four companies within the country, and Influenza medication, too and the medical treatment situation is in order of the vaccine in that situation, too.

Kuniko of Shindo (halberd of -) medical affairs government of World Health Organization (WHO) : in July when the import policy was shown for the first time. ｢Regrettable impression. The international society might be surprised. ｣With the indication. The dissemination lingua of the proposal such as "It is necessary to think about validity from an international aspect widely" of the group of the biosis medical ethics system of University of Tokyo this month. An opinion not positive is not few in the import in a domestic specialist.

Health Minister Masuzoe is speaking, "I want to make an effort ..not going to another country because of buying up of Japan..".

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