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
- Environmental Issues
- Food Safety
- GMP, GCP, GLP, QSR
- Patient Assistance Programs
- Privacy/Data Exclusivity
- Use of Human Genetic Resources
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.
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.
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.