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言語選択:

世界中至るところで皆様の企業ゴールを達成するために、シドリーの先駆的なグローバル ライフ サイエンス プラクティスは、世界中に所在するオフィスに多数の法的規律に携わるおよそ200名の経験豊富なチームを擁しております。

規制、コンプライアンス及び執行、訴訟並びにトランザクション案件全般の助言をする中で、業界の変化、技術の進歩、マーケット需要及び政策の壁にうまく対応し潤滑に案件を進める包括的な法律提案を提供しております。

“全米、ヨーロッパ及びアジアに際立つ存在感をもつ素晴らしいグローバルファーム”
チェンバースグローバル2019 グローバル ワイド:ライフサイエンス

連絡先

“規制当局の認可、知的財産から法廷での直接対決まで、シドリーですべてをカバーできる。実際、シドリーはすべてを代理してくる。”
LMGライフサイエンス2018 IP訴訟を除く訴訟及び執行

クライアントのニーズにお応えします

卓越したインサイトを駆使した取組 多くのチームメンバーは高度なテクニックを有し、複雑な自然科学及び臨床案件の取り扱いに関し、非常に長けております。私共は政府見解に関し過去の政府内経験により精通しており、これは多角的要素、国境を越え多国間をまたがるビジネス、文化及び法的適用が難しい地域での助言に役立っております。多くの弁護士が重要な規制当局の上級職に従事していた経験を有しており、こうしたチームの主要な政府機関経歴を生かしてクライアントを代理することで、米国食品医薬品局(FDA)、メディケア・メディケイドサービスセンター、米国司法省、欧州委員会及び公式には中華人民共和国国家食品薬品監督管理局として知られる中国国家薬品監督管理局等と折衝し成功裏に導いています。

垣根のないグローバルストラクチャーは私共プラクティスの根幹です。三大陸に広がり、非常にまとまりの良い総合チームが織りなす業務はバイオテクノロジー、医薬品及び医療機器業界に先駆的な法的助言を行っています。チームを構成する優秀な人材及び世界的展開により、迅速に、世界中のどこにあっても即座にあらゆる規模の案件にも陣容を整えることが可能です。

シドリーはグローバル イノベーター特有の課題を理解しています。先駆者的遺伝子療法及び細胞治療、ハイテクソフトウェア及び境界製品を伴う新しい分野を進める上で、クライアントは技術の進歩に呼応する複雑な規制に同時に対峙しなければならなりません。規制当局を取り巻く何十年もの経験と詳細な知識を有し、製品ライフサイクルのあらゆる段階において時に、重大かつ時に沸き起こる新たな問題について助言してまいりました。

迅速な対応と実践的な問題解決は私共のサービスの核心です。皆様が経営目標を達成する過程で直面する数々の圧力に対し、救済するすべを心得ております。また私共チームは常に現場で起きている問題に積極的に対応いたします。議論となりそうな問題点を優先的かつ率先して取り組むことで優位に進めることができます。これには規制当局との初期段階で十分に折衝し、友好な関係を築いていくことを含みます。

“シドリーの弁護士は先を見越し、実践的かつ対応が早い”
チェンバーズ グローバル 2019 アジアパシフィック:ライフサイエンス

業界を熟知するチーム構成 私共の経験豊かな人材は、ライフサイエンスの大勢を形成し続ける法律及び政策の草案にかかわってきた弁護士で構成されています。内100人以上が以下に記載される世界の規制当局及び政府機関の高官経験者で成り立っています。

  • アメリカ合衆国保健教育福祉省 (HHS)
  • アメリカ合衆国食品医薬品局 (FDA)
  • ホワイトハウス
  • アメリカ合衆国司法省
  • 主たるアメリカ合衆国議会委員会
  • 欧州委員会
 
  • スイスメディック
  • 欧州医薬品庁(EMA)
  • 中国国家国務院(中華人民共和国)
  • 中華人民共和国外交部
  • 中華人民共和国商務部 (MOFCOM)


成功の記録

クライアントへの助言に強力なリーダーシップを発揮することで、チェンバース グローバル、チェンバースUSA及びチャンバース アジアパシフィック、チャイナ ビジネス ロージャーナル、LMGライフサイエンス、U.S.ニュースーベストロイヤーズ “ベスト ローファーム”調査等、数多くの業界誌より常に取り上げられています。

Sidley has a powerful, fully integrated Global Life Sciences practice. In China, our practice serves multinational pharmaceutical, biotechnology, medical device and food companies in every aspect of their business operations.

Sidley’s experience in foreign direct investments (FDI), commercial corporate/M&A, licensing and joint ventures, China anti-bribery/U.S. FCPA compliance, antitrust, intellectual property and local enforcement work, as well as our regulatory experience, allows us to advise on virtually every facet of life sciences operations in China.

Sidley was the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. As an integral part of our Global Life Sciences practice, we bring our knowledge of industry practices in the U.S. and EU to each project in China and help develop global Standard Operating Procedures (SOPs) and benchmark best practices.

We were honored in December 2013 with a Memorandum of Understanding (MOU) issued by the China Center for Pharmaceutical International Exchange, a public institution affiliated with the China Food and Drug Administration, and, in January 2008, by the Shanghai Institute for Food and Drug Safety, a public institution affiliated with the Shanghai Food and Drug Administration. Under these MOUs, Sidley provides input into new drug, device, food and cosmetics laws and regulations; also co-hosts seminars and training programs for the industry and government officials.

Life Sciences Regulatory Advice

More than 50 leading global pharmaceutical, biological, medical device and food manufacturers have turned to Sidley for life sciences regulatory advice in China. Our regulatory experience covers areas such as:

  • Adverse Drug/Device Event Reporting
  • Audits/Investigation on Quality Issues
  • CFDA Drug and Medical Device Approvals
  • Clinical Trials
  • Counterfeiting Countermeasures
  • Distribution Agreements
  • Drug/Device Pricing & Reimbursement
  • Drug/Device Promotion
  • Drug/Device Recalls
  • Drug/Device/Cosmetic/Food Labeling
  • Enforcements
  • Environmental Issues
  • Food Safety
  • GMP, GCP, GLP, QSR
  • Licensing
  • Patient Assistance Programs
  • Privacy/Data Exclusivity
  • Use of Human Genetic Resources
  • Vaccines

China Product Development and Regulatory Strategies

China represents one of the most important strategic emerging markets for pharmaceuticals and medical device. Accelerating development and time-to-approval to bring new innovative products into China calls for a comprehensive strategy and effective execution. Our local knowledge and insight, combined with our global network, are right there to support your product development needs in China.

  • Advising on pathways for early product development to facilitate due diligence decision making in M&A, licensing, and joint venture transactions: Reviewing product profiles, assessing China regulatory issues and providing strategic recommendations.
  • Advising on product development strategies and tactical plans for clinical trials and registration in China: Evaluating and providing professional opinions on specific regulatory and clinical program plans including, program and protocol design, and implementation plans to help speed approvals.
  • Product development lifecycle advice: navigating China’s regulatory and clinical trial environment: Providing professional advice to support proactive regulatory planning, providing guidance on issues requiring prompt responses
  • Regulatory Agency interactions: Developing regulatory meeting strategies, supporting the planning, preparation and organization of formal regulatory meetings and consultations.
  • Advising on areas such as CRO/vendor identification and assessment, proper clinical trial set-up and compliance with ICH and Chinese regulations, clinical trial operational issue assessment and resolution, drug safety and pharmacovigilance programs.
  • Advising on regulatory policy review, analysis and advocacy initiatives, projects and activities.

Corporate / M&A / Licensing / Joint Venture

More than 70 lawyers handle corporate matters in Hong Kong, Beijing and Shanghai, our three offices in China, and are supported by lawyers in our Tokyo, Singapore and Sydney offices. Professionals in our China offices have worked on a comprehensive range of foreign direct investment, M&A, joint venture and corporate restructuring matters in China, and our in-depth regulatory knowledge makes the difference in a variety of corporate and commercial transactions for life sciences companies, including:

  • Handling mergers, acquisitions, restructurings, divestitures and liquidations in China;
  • Advising on the establishment of equity and co-operative joint ventures (EJV/CJV), wholly foreign-owned enterprises (WFOE), holding companies and representative offices.
  • Advising on all stages of foreign-invested enterprise (FIE) projects for life sciences clients in China, including the evaluation and selection of appropriate commercial vehicles, performing due diligence, drafting contracts in Chinese and English, negotiating with Chinese partners and Chinese government officials, effecting registrations and procuring government permits and approvals.
  • Handling contractual, licensing and intellectual property rights, tax, foreign exchange, labor, land use rights and regulatory matters and other complex issues that arise alongside FIE projects in China.

FCPA and China Anti-Bribery Law

Sidley has extensive experience representing clients with respect to the Foreign Corrupt Practices Act (FCPA) and Anti-Bribery enforcement laws in China. We are well-versed in laws that relate to dealing with government officials.

We have assisted U.S. and European drug and device companies in

  • Responding to FCPA and Chinese anti-bribery investigations and enforcement proceedings,
  • Conducting internal compliance reviews,
  • Designing remedial actions,
  • Creating and implementing compliance programs, developing local best practice guidelines, and,
  • Implementing compliance training programs.

Antitrust

China’s Anti-Monopoly Law (AML) brings new regulatory challenges to multinational companies in connection with their joint venture and M&A projects in China, as well as most types of commercial activities. Sidley’s extensive experience in antitrust matters in China, coupled with its in-depth understanding of Chinese business and culture, allows us to help clients devise effective solutions to antitrust compliance in China.

We have provided advice to global drug and medical device companies in connection with merger clearance filings for joint venture and M&A projects, as well as AML compliance for distribution agreements, co-promotions agreements and pricing strategies.

In addition, since 2005 Sidley has represented the China Chamber of Commerce of Medicines & Health Products Importers & Exporters, and later the Ministry of Commerce (MOFCOM), in the first-ever U.S. federal antitrust litigation against Chinese pharmaceutical companies. Through our representation of MOFCOM, we have established a very close working relationship with the MOFCOM officials administering the AML.

Intellectual Property

Our China team provides strategic and advisory services to many of the top multinational pharmaceutical and medical device manufacturers in China on diverse intellectual property matters, including those relating to technology transactions, joint ventures and other corporate transactions.

Sidley’s International Intellectual Property group has extensive experience in the life sciences industry. Many of our lawyers carry joint degrees in science and have significant experience working in the field of global health. Our experience covers the entire product life cycle, including research and development, pre-clinical, clinical and commercial contract manufacturing, filling, finishing and packaging, storage, testing, clinical trials and distribution.

Our Team

Our China Life Sciences team is led by partner Chen Yang, who is recognized as a leader in both regulatory and commercial/corporate law in the industry in China. The team consists of experienced and industry-dedicated professionals, particularly including partner Yuet Ming Tham, the former Asia Pacific Regional Compliance Director for an multinational pharmaceutical company and Lei Li, the former government attorney at the Ministry of Commerce of China (MOFCOM) with substantial experience in antitrust, FCPA compliance and international trade matters. Our practice is further enhanced by partners in Shanghai office, including Zhengyu Tang, one of the top corporate/M&A lawyers in China, and Joseph Chan, who has extensive experience in the investment funds and corporate/M&A transactions targeting the life sciences industry.

連絡先