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• Japan drug approvals
• Pricing & Reimbursement
• Japanese pharmaceutical regulations
• Pharmaceuticals & Biologicals
• Medical devices
• Quasi-drugs & Cosmetics

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JAD NEWS

March 17, 2008: Introduction to JKS News

February 14, 2008: JKS News launched

October 26, 2008: JAD Databases and Drug Price List service

Jouhou Koukai Services LLC and its businesses provide information and intelligence on the Japanese pharmaceutical market in the fields of drug and medical device approval, regulatory and pharmaceutical affairs, and market data.

Company of the week:
Momenta Pharmaceuticals & Copaxone

 

Regulatory and Commercial Headlines

JKS News: XML  RSS feed

July 24, 2008: JKS News: MHLW made public the 2008 draft version of "Medical Devices Industry Vision" mapping plans for the next 5 years, now soliciting public opinions ... Medical devices / IVD consulting
July 23, 2008: JKS News: Otsuka Holding Group a diversified 100-member conglomerate to acquire all Itoham Life Science KK properties including American Peptide Co. to expand its ingredients and API capacities ... Otsuka products in JAD Databases | related report preview
July 22, 2008: MHLW announces coming release of "Five Peace-of-Mind Plans" for overhaul of social security system, possibly ministry's administrative restructuring ...
July 22, 2008: Momenta Pharmaceuticals successfully submitted in US the first generic version of Copaxone (Glatiramer acetate), an yet unapproved in Japan product indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (MS) ... related report preview
July 18, 2008: JKS News: MHLW released for qualified public comments the Step 2 draft of ICH Harmonised Tripartite Guideline "Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" ... Japanese guidelines consulting
July 17, 2008: JKS News: Kinetic Concepts Inc. announced that by end of June has completed in Japan the Phase II trial required for approval of its negative pressure wound therapy (NPWT) technique ... medical device consulting
July 16, 2007: JKS News: The Japan Medical Association published a full-page petition in national newspapers soliciting Japanese citizens to protest 220 billion Yen health insurance cost-reduction plan of the Government
July 16, 2008: MHLW approved 23 new products, including anti-cancer drugs in summer round of approval ... details in JAD Databases  |  related report preview
July 15, 2008: JKS News: PMDA starts soliciting public comments in relation to the Pharmacopoeia Discussion Group (PDG) international harmonization of the Japanese Pharmacopoeia XV ... Information Meetings reports

...more headline news

DOCUMENTS STORE

Japan Master Files - view

Accredited Foreign Manufacturers preview

Japan Orphan Drugs
preview

Japan Pricing & Reimbursement preview

Japanese Generics and API
preview

Stigmatized Markets: ED
preview

Stigmatized Markets: Depression preview

Stigmatized Markets: Genital Herpes preview

Stigmatized Markets: Metabolic Syndrome preview

Unapproved Medicinal Products (drug lag) preview

IN THE MEDIA

EContent Magazine: Jouhou Koukai Adds to Database

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JKS, HR Department