Katherine Wang

Chief China Life Sciences Advisor

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  • LLM, Harvard Law School, 2000
  • LLM, National Taiwan University, Taipei, 1999
  • LLB, National Taiwan University, 1997

Qualifications

  • New York, 2002
  • Chinese (Mandarin)
  • English

Katherine Wang

Chief China Life Sciences Advisor

Katherine Wang is chief China life sciences advisor in our Shanghai office. Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of commercial and regulatory matters, including early-stage discovery, product registration, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine represents life sciences companies in response to various inquiries from agencies including the China Food and Drug Administration (CFDA) and the Administrations of Industry and Commerce (AICs), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China.

Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.

Experience

  • Routinely advises foreign life sciences companies on their China entry strategies, particularly issues relating to the selection of regulatory pathways, availability for fast track approvals and regulatory exclusivities.
  • Routinely advises multinational pharmaceutical and medical device companies on issues arising from their clinical studies in China, particularly concerning localization of clinical study agreement templates, regulatory approvals, informed consent, waiver for registration studies, permissibility of non-registration studies, importation of clinical study drugs, contract manufacturing of placebos, study insurance, privacy protection, dealings with CROs, research injuries, and dispute resolution.
  • Counsel to several multinational pharmaceutical companies in the conduct of secondary medical research in China, e.g. collection, use, import and export of human biological samples, construction of biobanks through collaborations with Chinese hospitals, and radioactive labeling of human biological samples in China.
  • Routinely advises multinational pharmaceutical and medical device companies on issues concerning statutory compliance of promotional practices, particularly commercial bribery risks associated with various marketing initiatives, off-label promotion, and patient communication.
  • Advised several privately-owned medical device manufacturers headquartered in the US on the establishment of its green-field operation in China; assisting in the regulatory approval process for medical device distribution and manufacturing licenses; assisting in registration of Made-in-China products.
  • Advised several multinational pharmaceutical and medical device companies on regulatory issues associated with localization of product manufacturing in China.
  • Advised several multinational pharmaceutical and medical device companies on market access issues in China, particularly related to pricing, reimbursement, and tendering.
  • Counsel to several multinational pharmaceutical companies in the conduct of feasibility analyses of acquiring a pharmaceutical distribution company in China.
  • Advised several multinational life sciences companies and investment funds on the general regulatory environment concerning OTCs, cosmetics (including medical aesthetics), dietary supplements, and veterinary drugs in China.
  • Advised institutional and corporate investors in the conduct of regulatory due diligence on issues ranging from product registration, compliance with GLP/GCP/GMP, and pharmacovigilance/device safety of their potential investment targets in China.

Awards

  • The International Who’s Who of Life Sciences Lawyers (2013 - 2014)
  • Chambers Asia: Asia's Leading Lawyers in life sciences (2011 - 2014)
  • Chambers Global: The World's Leading Lawyers for Business (2014)

Insights

Publications

  • Quoted, “The risks and opportunities for pharma under China’s new rules,” Scrip Regulatory Affairs (March 2014)
  • “Multinational Pharmas: Expect Key Policy Shifts in China”, Law360 (December 2013)
  • "China Offers New Possibilities for Drug License Transfers," Update (May/June 2013)
  • "Navigating China’s Regulatory Landscape for Commercial Success," Pharma (June 2013)
  • "Pharma Cos., Scan Your Drugs for Proper Barcodes," Law360 (February 2013)
  • "Payers and Reimbursement in China," DIA Global Forum Special Section (October 2012)
  • "China Gets Tough on Labeling and Packaging of Medtech Imports," Scrip Regulatory Affairs (August 2012)
  • "New Rules in China Tighten ADR Reporting Environment," Regulatory Affairs Pharma (July 2011)

Presentations

  • Speaker, "Riding the New Wave: How to Prepare Your Life Sciences Company for Compliance and Success in the Face of China's Recent Regulatory Changes," Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference (January 2014)
  • Moderator, "Medical Devices: How New Rules Will Impact Your Business," FDLI’s International Conference: China-US Updates in Food and Drug Law (October 2013)
  • Speaker, "China Entry through Joint Ventures," China Forum 2013 (October 2013)
  • Speaker, "Responding to Regulatory and Reimbursement Challenges to Pharma Sales and Marketing," China Pharmaceutical SFE & Marketing Excellence Conference (November 2013)
  • Speaker and Moderator, "New Biosimilar Regulation: Challenges and Opportunities in China" and "Medical Device Innovation:  From Bench to Bedside," DIA China Annual Meeting (May 2013)
  • Speaker, "Stem Cells: Perspectives on Intellectual Property and Regulation," Ropes & Gray Tokyo Morning Briefing Teleconference (February 2013) 
  • Speaker, "Navigating China's Complicated Life Sciences Regulatory System for Commercial Success," Ropes & Gray West Coast Lunchtime Legal Briefing Teleconference (January 2013)