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世界の薬事規制と承認審査に関するニュースサービス

世界的に新薬の開発競争が激しさを増す中、売上の最大化やドラッグ・ラグ解消の必要性から、海外との同時申請や国際共同治験も増えています。特に薬価の抑制政策やジェネリック医薬品の普及などにより、国内新薬市場の伸び悩みが予想される日本の医薬品企業や医療機器メーカーにとって、海外の薬事規制や承認審査制度について知悉することはとても大切です。

Pink Sheet(ピンクシート)では、アメリカ食品医薬品局(FDA)や欧州医薬品庁(EMA)など海外の承認審査や薬事規制当局の動きだけでなく、薬事に関連する下記のトピックについてもニュースを配信しています。

Pink Sheetは以下のトピックもカバーしています:
薬価、薬物安全性、知財、マーケットアクセス、価格・償還制度、生産・製造、臨床試験など

長年、世界のレギュラトリー・アフェアーズをみているジャーナリスト&アナリストチームが、薬事規制がビジネスに及ぼす影響について独自の考察を交えて記事を執筆しています。

Pink Sheetの購読ページでは、ログインしなくても各ニュースの冒頭を読むことができます。また、姉妹サービスのScrip(スクリプ)では、世界中の医療用医薬品と製薬産業全般に関する包括的なニュースを配信しています。あわせて購読されるとより効果的です。

このサービスの特徴

無料の最新記事&レポート

  • Pharma consulting: 医療用医薬品のコンサルティング

    Custom Intelligence Biosimilars Report

    04 Nov 2019

    Custom Intelligence Biosimilars Report

    You’ve probably noticed that biosimilars are the growth engine in global medicine spending right now. You’re not alone. With biologics accounting for 20-22% of total pharmaceutical spending already and looking to grow to $320 bn in the US alone by 2023, more and more companies and looking to compete in this arena. Informa’s Biosimilars Insights and Analysis Service can bring you the market intelligence and insights to inform your decisions and help ensure you’re not missing out on opportunities.

    Topic biosimilars

  • Pharma consulting: 医療用医薬品のコンサルティング

    Custom Intelligence Biosimilars Whitepaper

    By Duncan Emerton 04 Nov 2019

    Custom Intelligence Biosimilars Whitepaper

    If you’re looking at the opportunities to increase revenue and mitigate current and future threats by formulating the strongest biosimilars strategy, Informa’s Biosimilars Insights and Analysis Service is the tool you need.

    Topic biosimilars

  • Pharma consulting: 医療用医薬品のコンサルティング

    Commercial optimization

    By Pharma Intelligence 03 Sep 2018

    Commercial optimization

    The Issue Our client asked us to help support their CNS product portfolio strategy by helping to understand the clinical and commercial potential of the schizophrenia market

  • Pharma consulting: 医療用医薬品のコンサルティング

    Problem Solving Methods of US and EU Pharmaceutical Companies

    22 Aug 2018

    In this webinar recording, Timothy Pang, Senior Director for Informa Pharma Consulting, weighs in on how Pharma Consulting has been helping European and US Pharmaceutical companies tackle complex and specialized challenges; whilst developing strategic and operational plans; and improve the efficiency and bolster revenues.

    Topic business-strategies company-analysis

  • Pharma consulting: 医療用医薬品のコンサルティング

    Pharma Consulting 2018 Brochure

    15 May 2018

    Pharma Consulting 2018 Brochure

    With Pharma Consulting services, you tap into the expertise of our experienced consultants who leverage the data, resources and . expertise of our market-leading intelligence sources and develop authoritative. Download the Pharma Consulting brochure, which includes contact information and discover the power of our consulting solutions.

  • Pharma consulting: 医療用医薬品のコンサルティング

    Pharma Consulting Whitepaper

    30 Apr 2018

    Pharma Consulting Whitepaper

    Accurate benchmarking has never been more important to the biopharma industry than now, with increased scrutiny related to development costs at an all-time high. What benchmarks are you using? How does your development program compare to those of your competitors? Explore the importance of benchmarking, specificity, and consulting as they relate to drug development approval rates in biopharma with Pharma Consulting - Probabilities of Technical Success in Biopharma, the informative whitepaper from Informa’s Pharma Consulting.

  • Pharma consulting: 医療用医薬品のコンサルティング

    Competitive landscape assessment and monitoring

    11 Sep 2017

    Competitive landscape assessment and monitoring

    The Issue: A global pharmaceutical company needed to assess the current and future competitive landscape of an early-stage analog drug to determine the possibilities of market entry and the viability of possible differentiation strategies to compete in the market. 

  • Pharma consulting: 医療用医薬品のコンサルティング

    Benchmarking Loss of Exclusivity (LOE) and Price Evolution

    11 Sep 2017

    Benchmarking Loss of Exclusivity (LOE) and Price Evolution

    The Issue: Our client wished to understand the potential impact of the competitor’s drug going generic on their brand and whether there would be any spill-over effects.

  • Pharma consulting: 医療用医薬品のコンサルティング

    Pharma Consulting

    27 Jun 2017

    Biopharma portfolio management, commercial optimization, and R&D strategy can be tricky. We develop customized solutions to help you make better informed strategic decisions.

  • Pharma consulting: 医療用医薬品のコンサルティング

    Probability of Technical Success

    By Pharma Intelligence 01 Jan 2016

    Probability of Technical Success

    Issue A large biotech needed the correct analogs for follow-on biologics PTS in Oncology and Respiratory programs across a range of segments to assess the risk of their portfolio  

  • Pharma consulting: 医療用医薬品のコンサルティング

    Qualitative market research with payers in the EU and Japan

    By Pharma Intelligence 01 Jan 2016

    Qualitative market research with payers in the EU and Japan

    The Issue: The client was looking to develop a deeper understanding of the payer landscape in Europe and Japan as part of an overall market opportunity assessment

医薬品産業専門のジャーナリスト&アナリスト

Editor

Brenda Sandburg

Editor, Senior Editor

New York, USA

Brenda Sandburg

Brenda specializes in

  • Policy & Regulation
  • Biosimilars
  • Biotech
  • Generics
  • Pricing & Reimbursement

+39 year(s) experience

Editor

Cathy Kelly

Editor, Senior editor

Washington DC, USA

Cathy Kelly
Management

Denise Peterson

Management, Editor In Chief, Pharma US

Washington DC, USA

Denise Peterson

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