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John C. Balzano

Partner

New York +1 212 841 1094

English
  • About
  • Representative Matters
  • Credentials
  • About

    John has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China and APAC, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

    He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, implementing product recalls, and supporting virtual and onsite overseas quality inspections. John also has significant experience designing strategies to handle professional consumer litigation for companies operating in China and working with local counsel.

    He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

    He is the author of the book, China Food and Drug Law: Policy, Practice, and Future Directions (Springer 2024).

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Assisted business associations with drafting and submission of comments on draft legislation and regulations to National Medical Products Administration.
    • Developed policy papers on regulatory developments in China, related to drug regulation and infant formula regulation.
    • Developed briefs and regulatory submissions for multi-national companies to respond to enforcement inquiries and over one hundred processional consumer cases related to labeling and formulation issues.
    • Advise on digital health regulatory issues, including mobile app registration and telemedicine.
    • Assist food, animal health, drug and medical device companies with regulatory due diligence on M&A deals and on distribution and collaboration partners.

    • Advise on GxP compliance for drug and device companies, including on China-U.S. cross-border aspects of clinical trials.
    • Advised on China e-commerce regulatory compliance for cosmetics, food and health food products.
    • Advise on standard operating procedure and other strategies to protect trade secrets in the drug and device development process in China.

    Areas of Expertise

  • Credentials
    Education
    • Washington University School of Law, J.D., 2004
    • Washington University, M.A., 2004
        • East Asian Studies
    • Columbia University, B.A., 2001
        • East Asian Languages and Cultures
    Bar Admissions
    • Connecticut
    • New York
    Judicial Clerkship
    • Hon. Joette M. Katz, Supreme Court of Connecticut, 2007 - 2008
    • Hon. Steven M. Gold, U.S. District Court, Eastern District of New York, 2006 - 2007
    Languages
    • Mandarin
    • Japanese
    Pro Bono
    • Developed policy paper on hate crime legislation in Asia, South Asia, and the U.S. for use in aiding legislators in other countries in creating comparable schemes.
    • Represented incarcerated individual in completing name change proceedings.
    Previous Experience
    • Prior to joining the firm, John taught Chinese law and transnational litigation at Boston University Law School. He was also a fellow, and then a senior fellow and a lecturer in law, at the China Law Center of Yale Law School, where he worked with Chinese officials from central and local government agencies and academics on cooperative projects related to the drafting of legislation and regulations in China, primarily in the areas of administrative law and food and drug law.
    • John was in private practice in New York as a litigator from 2008-2010, where his experience included representing companies in transnational litigation.
    • In 2004, he was an intern to Rep. Takashi Shinohara in the Japanese House of Representatives.

    Areas of Expertise

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