Skip to content
This is available in:

Driven to help you achieve your business goals wherever they may take you in the world, Sidley’s pioneering Global Life Sciences practice comprises an experienced team of approximately 200 lawyers across numerous legal disciplines in our offices around the world. We understand the challenges you face in the course of conducting business across the global drug and device supply chain, having counseled high-profile clients in every sector of the dynamic life sciences industry.

Advising on the full scope of regulatory, compliance and enforcement, litigation and transactional matters, we can offer you a holistic legal approach that will smooth your path as you navigate industry changes, technological advances, market demands and policy hurdles.

“Impressive global firm with a significant presence in Europe and Asia and across the USA.”
Chambers Global 2019, Global-wide: Life Sciences

Contacts

“From regulatory clearance, to IP, and right down to all-out court battles, Sidley has got it all covered. They really do it all.”
LMG Life Sciences 2018, Non-IP Litigation & Enforcement

Attuned to Your Needs 

Uncommon insight to your work. Many members of our team hold advanced technical degrees, making us uniquely adept at handling complex scientific and clinical issues. Our insider’s perspective of government is also an important feature we bring to bear in advising your multi-faceted, multinational business across borders, cultures and tough legal terrain. A number of our lawyers have years of experience serving in senior roles at key regulatory agencies. Our team’s substantial government credentials include successfully representing clients before agencies such as the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services, the U.S. Department of Justice, the European Commission and the National Medical Products Administration, formerly known as the China Food and Drug Administration.

A seamless global structure is the bedrock of our practice. Spanning three continents, our integrated team works together as a cohesive unit to provide pioneering legal advice on the biotechnology, pharmaceutical and medical device industries. Our deep bench and global reach allow us to be nimble, staffing up any size matter at a moment’s notice anywhere in the world.

We understand the unique challenges of global innovators. While charting new terrain with pioneering gene and cell therapies, high-tech software and borderline products, our clients simultaneously confront complex regulations that struggle to keep pace with the evolving technologies. With decades of experience and in-depth knowledge of the regulatory environment, we have advised on significant, often novel issues, at every stage of the product life cycle.

Responsiveness and practical problem-solving are at the heart of our work. We know and seek to remedy the pressures you face in the course of accomplishing your business objectives. The team is also proactive in response to issues breaking on the ground. By prioritizing and preemptively addressing contentious issues, we can help you stay ahead of the curve. This includes engaging with the regulators early and often, and in a way that maintains our positive relationships with them.

“The lawyers are proactive, practical and provide quick responses.”
Chambers Global 2019, Asia-Pacific: Life Sciences

Industry acumen defines our team. Our deep bench comprises lawyers who have given input into the drafting of the laws and policies that continue to shape the life sciences landscape. This includes more than 100 former senior officials from regulatory agencies and government bodies around the world, such as:

Global Life Sciences
  • the U.S. Department of Health and Human Services (HHS)
  • Centers for Medicare & Medicaid Services (CMS)
  • the U.S. Food and Drug Administration (FDA)
  • the White House
  • the U.S. Department of Justice (DOJ)
  • key U.S. Congressional Committees
 
  • the European Commission 
  • Swissmedic
  • the State Council of the People’s Republic of China (P.R.C.)
  • the Ministry of Foreign Affairs of the P.R.C.
  • the Ministry of Commerce of the P.R.C. (MOFCOM)


A Record of Success

Strong leadership in advising clients has consistently earned us acknowledgement from numerous industry publications, including Chambers Global, Chambers USA and Chambers Asia-Pacific, China Business Law Journal, China Law & Practice, LMG Life Sciences and the U.S. News – Best Lawyers® “Best Law Firms” Survey.

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.

Contacts