Drug approvals and pharmaceutical affairs in Japan

April 2024
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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.

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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,, 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)

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