Jouhoublog
Drug approvals and pharmaceutical affairs in Japan
Categories:

Archives:
Meta:
September 2017
M T W T F S S
« Mar    
 123
45678910
11121314151617
18192021222324
252627282930  
01/20/07
Speedy, isn’t it?
Filed under: Approvals, Anticancers
Posted by: Kanri @ 4:33 pm

In contrast to the chorused complains against the - as lobbyists put it - “glacier speed” of new drug approval in Japan, the chronology of Alimta shows quite the opposite. Let’s follow:

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

Technorati Tags: ;

comments (0)
02/12/06
Silver lining of Iressa
Filed under: General, Approvals, Medicinal products, Anticancers
Posted by: Kanri @ 6:39 pm
If the approval of Iressa happened to be if not a cloud, but at least cloudy, it also has a silver lining. Both in response to the public criticism and along with the newer obligations concerning the pharmacovigilance, the authorities have decided to start disclosing information on advirse events (AEs) reported for medicines approved in Japan. Although it is hardly to assume that the disclosure step has been prompted solely by the Iressa saga, yet the reaching of Iressa incidents to the general public nonetheless served as a catalyst.
 
Remarkably, the AEs data - previously elusive even to professionals, are now readily open to the public. Many pharmaceutical companies in Japan have fallen to third party providers to make available even for professional audience - such as physicians and pharmacists, and even the most innocent pieces of information - such as photographs of the packages, against charges and detailed registration. The Government took an opposite approach to have all the data posted at no charge and accessible without any tracking. Commendable.

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

Technorati Tags: ;


Web site to offer information on drug side effects
 
The Pharmaceutical and Medical Devices Agency on Tuesday launched a Web site that enables people to search for lists of side effects, symptoms and associated diseases brought on by a variety of medicines. The site, www.info.pmda.go.jp, includes a database of all side effects as reported by drug manufacturers. The first data to be made public by the agency was in April 2004, with accounts detailing 732 medicinal products and 2,477 related case studies that include information such as age, gender, disease, details of the side effects, the drug and other medicines taken concurrently. The site also includes case studies for the 63 people whose deaths during that period were brought on by side effects from medicines they were taking. Twelve of these deaths were linked to the lung cancer drug gefitinib, marketed as Iressa. Warnings also are included for cases in which the side effects were found to not be connected to health problems. The PMDA will make information from May 2004 onward available in due course, aiming to put a system into effect before the end of March 2008, with updates every six months. Until now, such reports were limited to cases involving previously unknown side effects, or where revisions had been made to warnings over usage. The new system was conceived of in the face of increasing complaints from citizens’ groups and others organizations demanding all the information be made public, as only 1,872 of the 25,000 or so drug-related side effects last fiscal year had been disclosed. The agency, an independent organization, has also begun posting on its Web site easy-to-understand explanations on dosage and side effects. Beginning with 54 kinds of drugs, including oral diabetes medication, the next medicines to be posted will include antirheumatic and antiasthmatic drugs. (The Daily Yomiuri, February 9, 2006, p. 3)
comments (0)
12/02/05
Warning before approval
Filed under: Approvals, Medicinal products, Anticancers
Posted by: Kanri @ 8:07 pm

Femara - an aromatase inhibitor - is known to be submitted and currently under a review by the Japanese regulatory authorities. Yet, as distributed today by the mass media, the warnings issued by Novartis AG were forwarded to the physicians in Japan as well. As read between the lines - under the provision of the Pharmaceutical Affairs Law (PAL), any unapproved drug could be imported for individual use in Japan as long as the custom official is shown a prescription by Japanese doctor. Obviously, Femara (the name is misspelled in the original news release below) - another of the unapproved anti-cancer drugs in Japan has been imported by significant number of female patients treated domestically.

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

Technorati Tags: ;

 

Swiss firm warns breast cancer drug can harm unborn children
 
Thursday, December 1, 2005 at 07:15 JST
TOKYO — A Swiss pharmaceutical company has decided to warn gynecologists in the United States, Japan and other countries not to prescribe women a breast cancer drug during pregnancy or before menopause, as it may harm unborn children, officials of the its Japanese associate said Wednesday.
 
Letrozole, distributed by Novartis AG under the name Femera, is commonly used to prevent relapses of breast cancer. Animal tests have proven that the drug can cause fetal abnormalities and its use in pregnant and pre-menopausal women has been banned. 

comments (0)
08/01/05
What is more difficult?
Filed under: Approvals
Posted by: Kanri @ 10:03 am

One of the unapproved anti-cancer products, recommended so far by the Committee for the Examination of the Use of Unapproved Medicinal Products for domestic development is thalidomide, which was once registered and in 1962 withdrawn in Japan. The task for clinical development with a sole indication for treatment of multiple myeloma is being undertaken by the Fujimoto Seiyaku KK. The Osaka-based company is small, discloses its staff (about 300), but not the revenues. Apparently, it is run in a very traditional way, so one may wonder how it will survive the PR barrage while developing the notorious compound. On July 20, 2005 in what it seemed as a rare press conference the Fujimoto’s management reported the progress in planning the clinical trials: IRBs of 22 hospitals accepted the protocol and the recruitment of patients through informed consent has started. However, the trials are amidst of a considerable controversy. While for years the Japanese branch of International Myeloma Foundation (IFM Japan) has lobbied for official registration (in contrary to private use legal import), the relatives of the 60s disaster victims are voicing strong concerns regarding the safety. Surprisingly or not, no references of any kind about thalidomide on the web site of Fujimoto have been posted.

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

Technorati Tags: ;

comments (0)