Drug approvals and pharmaceutical affairs in Japan

November 2005
« Sep   Dec »
Flu fortune
Filed under: Medicinal products
Posted by: Kanri @ 2:04 am

In Japan the Pharmaceutical Affairs Law (PAL) permits individual import of both approved and unapproved drugs, as long as you have a prescription from Japanese physician.

Should we expect the Tamiflu to crash this winter the previous individual import record of Thalidomide (reportedly about 500,000 tablets were imported before the approval)?

Tamiflu is sold in Japan in two formulations: 75 mg capsules and 3% dry syrup, as the cost for 1-day treatment is 727.4 Yen for capsules and 1,392.5 Yen for the syrup. 

Reported below in Yomiuri Shimbun:

Shortages push Tamiflu prices up 10-fold

Online purchases have depleted stocks. One agent offers 10 capsules of Tamiflu, or oseltamivir, imported from the United States for 30,000 yen, excluding shipping charges. "One U.S. company recently told us the price had risen to more than 300 dollars. We need to raise ours to 38,000 yen just to show a profit," the company’s president said. According to the company, which has acted as an import agent for six years, demand for Tamiflu remained low until last year when 10 capsules could be obtained for 8,000 yen. The government in 2001 designated the drug to be covered by national health insurance.

Purchase orders for Tamiflu surged early this month following an increase in news reports on the spread of a new type of influenza and the government’s announcement of its plan to further stockpile the flu-fighting drug. The company received orders for about 20 sets in the past week. Another agent, which offers Tamiflu for 25,000 yen, said it was out of stock and had a waiting list of about 100 people.

Chugai Pharmaceutical Co., which imports and markets Tamiflu, prices the drug at 363.7 yen per capsule. A dosage of two capsules a day is normally recommended for five days, and a set of 10 capsules is offered at 3,637 yen. Insurance coverage reduces the price to about 1,100 yen, but it requires a doctor’s prescription, which increases to the total cost to about 3,000 yen.

(Nov. 24, 2005)

Jouhoublog is a joint blog - post or send comments to jouhoublog[at mark]

Technorati Tags: ;

comments (0)
Anticancer PR
Filed under: Anticancers
Posted by: Kanri @ 4:41 pm

In a rare PR move, the MHLW made publicly available through the mass media the previously adopted decision regarding changes in the approval qualification for anticancer drugs. Today Kyodo News Agency distributed in bilingual format the announcement that from April 1, 2006 the NDAs for anticancer drugs should include - along with the efficacy and safety profiles, data proving prolongation of patient life. Yet another of the Iressa aftershocks…

The new guideline from MHLW stipulates that data from Phase III studies in patients with non-small cell lung, stomach, large intestine and breast cancer should contain detailed evidences for life prolongation.

Ironically, Iressa (gefitinib) was one of the very few New Chemical Entities (NCE) to be first internationally approved in Japan and it turned into a regulator’s nightmare, as the cases of fatal interstitial pneumonia reached to the tabloids. Ever since the first news about lethal side effects of Iressa appeared in 2002, the MHLW found itself between rock and hard place: criticized for both negligence in "hastily" approving Iressa and systematically failing to approve other advanced anticancers.

Jouhoublog is a joint blog - post or send comments to jouhoublog[at mark]

Technorati Tags: ;

comments (0)