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Split and re-launched

We are receiving on a daily basis numerous inquiries concerning the regulated medicinal products (drugs, quasi-drugs, medical devices and cosmetics) and the regulatory affairs in Japan. To further make world-wide available the researched answers we have provided to the professional users and customers, a new interactive repository - Recentanswers has been re-launched as a blog. The Recentanswers Blog is an enhanced Frequently Asked Question (FAQ) system covering most of the queries and questions sent to the Regulatory Department of the JKS and to JKS in general. The answers not only address the issues, but also are extended to provide wider background information.
In contrast to Recentanswers blog, our other forum - Jouhoublog is preserved for the personal opinions of researchers and analysts working in the regulatory and business development fields. A number of events in the Japanese pharma industry warrant comments, especially the regulatory and procedural news what are largely ignored by the commercial news services.
All users and customers are encouraged to send queries for regulatory and other pharma, biotech and medical device issues by email to regulatory@jouhoukoukai.com

 Jouhoublog is a joint blog - post or send comments to . 

One of the leading Japanese shosha (general trading company) announced that in 20:80 partnership with a large foreign biotech-oriented venture fund has set up a service company under the apt name JapanBridge.

In the past three decades, an untold number of "Japan-bridging" companies were planned, set up and even still existed by entrepreneurs from both sides of the Atlantic (in the spirit of full disclosure, those included some of our founders).

What should be made the new JapanBridge different aside from the 100 million US$ expected to be pumped into the new entity within 3 years? The current answer is the new formula - taking only late clinical stage compounds from early stage biotech companies.

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)

Jouhoublog started as Askjouhou - a name now reserved for the JKS users forum.

Jouhoublog is a joint blog - post or send comments to .

Technorati Tags: MHLW; Japanese regulatory affairs