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John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.
Mr. Balzano has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated 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, 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, and implementing product recalls. Mr. Balzano also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic 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.
Mr. Balzano has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.
- 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.
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, Mr. Balzano 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.
- Mr. Balzano 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.
March 2021
As the legal, regulatory, and commercial implications of coronavirus COVID-19 continue to evolve, our lawyers and advisors are helping clients navigate the complex considerations that companies around the world are facing and develop plans and strategies in response. Reach out to our COVID-19 task force at COVID19@cov.com. Below is a compendium of resources ...
February 4, 2021
By: Aaron Gu On December 30, 2020, the State Administration for Market Regulation (“SAMR”) issued a three-year action plan for improving the quality and safety of dairy products in China (the “Plan”), reflecting China’s commitment to continue strengthening the regulatory and legal standards for dairy products, The Plan sets forth eight quantitative goals for the ...
January 25, 2021
By: Muyun Hu On December 25, 2020, the Institute of Food Science and Technology (“IFST”) issued China’s first plant-based meat standard T/CIFST 001-2020 (the “Standard”). The Standard will take effect on June 25, 2021. The Standard is a group standard issued by a government sponsored industry association and adopted by its members.[1] Group standards can ...
December 18, 2020, Food Safety News
December 9, 2020, Covington Alert
On October 17, 2020, the Standing Committee of National People's Congress (“NPCSC”), China’s top legislative body, adopted a Biosecurity Law (“Law”), which will go into effect on April 15, 2021. The Law reflects a growing area of regulation of drugs and medical devices in China that is separate from the regulations to ensure safety, effectiveness, and quality ...
July 14, 2020, Covington Alert
On July 3, 2020, the Standing Committee of the National People’s Congress (“NPC”) of China published a second draft amendment (the “Draft”) on the Patent Law of the People’s Republic of China (“Patent Law”). Most notably among the Draft’s proposed 29 revisions to the Patent Law, the Draft includes high-level provisions that would establish a framework for early ...
April 29, 2020, Covington Alert
On March 30, 2020, the State Administration of Market Regulation of China, the parent agency of the National Medical Products Administration (NMPA), released a revised Drug Registration Regulation (Revised DRR).
April 6, 2020, Covington Alert
This alert provides an update on the regulatory measures regarding medical-use and industrial-use personal protective equipment (PPE) from China to combat COVID-19, including a brief summary of measures the U.S. Food and Drug Administration (U.S. FDA) is taking to facilitate import of PPE from China into the United States. The regulatory guidance from both ...
March 29, 2020, Covington Alert
Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...
September 18, 2019
📄 Download PDF of Client Alert The Nagoya Protocol on Access and Benefit Sharing is the main global mechanism to regulate the access and utilization of biological resources. The agreement entered into force nearly five years ago, on October 12, 2014, as a supplement to the 1992 Convention on Biological Diversity Today, 118 countries are a contracting party ...
China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions
September 10, 2019, BioWorld
John Balzano is quoted in BioWorld regarding recent updates to China’s drug administration law and the establishment of marketing authorization holders (MAH). Mr. Balzano says, “This creates much-needed flexibility for research-based companies to develop products and bring them to market.” Another advantage of the MAH system is that licenses can officially be ...
September 9, 2019, Covington Alert
On August 26, 2019, China’s Standing Committee of National People's Congress (“NPC) adopted a significant revision of the Drug Administration Law (“DAL”). The newly adopted DAL (“Revised DAL”) will go into effect on December 1, 2019. The Revised DAL is the first overhaul of the DAL since 2001.
June 18, 2019, Covington Alert
On June 10, 2019, the State Council (China’s chief executive agency) promulgated the long-awaited Regulation on the Administration of Human Genetic Resources (the “Regulation”), which will become effective on July 1, 2019. The Regulation supersedes the currently effective regulations and guidance on human genetic resources (“HGR”).
March 4, 2019, Covington Alert
On December 29, 2018, the State Council (China’s chief executive agency) opened a new pathway for drugs to come into China through a special zone in southern China. It suspended certain central regulations in the Bo Ao Lecheng International Medical Tourism Pilot Zone in Hainan Province (“Pilot Zone”) and permitted local authorities to make marketing decisions ...
January 24, 2019, Covington Digital Health
On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here). Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all ...
October 12, 2018, Covington Digital Health
China continues to advance policy supporting e-healthcare services and resources. On September 14, 2018, National Health Commission (“NHC”) and the National Administration of Traditional Chinese Medicine (“NATCM”) publicly released three new rules on internet based medical services and telemedicine. These rules cover the areas of e-diagnosis (“e-Diagnostic ...
March 27, 2018, Covington Alert
China has reorganized many of the ministries and commissions under its chief executive body, the State Council, creating a new super-ministry to replace the China Food and Drug Administration (“CFDA”) and other healthcare agencies.
Law360 Names Attys Who Moved Up The Firm Ranks In Q4
January 30, 2018, Law360
Law360 highlights the promotion of Covington's newest partners, including John Balzano, Lindsay Burke, Bradley Chernin, Christopher DeCresce, Guy Dingley, Matthew Dunn, Laura Flahive Wu, Pamela Forrest, Alexa Hansen, Megan Keane, Sam Pyun, Kyle Rabe, Ansgar Simon, Andrew Soukup, Emily Ullman, and Mark Young.
November 6, 2017, Covington Alert
China has recently announced several initiatives to reform its regulation of drugs and medical devices that could have a significant impact on pharmaceutical and medical device companies doing business in China.
November 2, 2017, BioWorld MedTech
John Balzano is quoted in a BioWorld MedTech article regarding the decision by Chinese regulators to accept data from clinical trials conducted outside China for approvals of new drugs and medical devices. “In general, this statement is part of a long-term effort by the government and the China Food and Drug Administration that has been ongoing since 2015 to ...
Covington Promotes 16 New Partners
October 2, 2017
WASHINGTON—Covington has promoted 16 lawyers to its partnership. “It’s a great tribute to the firm’s vibrancy that we’re continuing to build an exceptional pipeline of new partners from within our ranks,” said Timothy Hester, Covington’s chair. “We’re confident that all 16 will add importantly to the firm’s strengths and will drive further expansion of core ...
June 29, 2017, The American Journal of Bioethics, 17:7, 51-53
May 23, 2017, Covington Alert
On May 11 and 12, 2017, the China Food and Drug Administration (“CFDA”) published drafts of four proposed policies in the form of circulars (or notices) for public comment. These “Proposed Policies” include significant reforms in the areas of the new drug and device approval process (“Circular 52”), clinical trial regulation (“Circular 53”), life-cycle ...
April 7, 2017, Covington Alert
On March 17, 2017, the China Food and Drug Administration (“CFDA”) released a notice to seek public comments on four proposed adjustments to China’s drug registration requirements (“Proposed Adjustments”) that will remove some barriers to applications for clinical trials and drug registrations of imported drugs (drugs that are manufactured outside of China). The ...
January 23, 2017, Covington Alert
On January 9, 2017, eight Chinese ministries announced a significant new policy that aims to reduce marked-up prices and corruption in multi-tier distribution chains. The policy effectively requires that under most circumstances, at most two invoices may be issued throughout the distribution chain, with one from the manufacturer to a distributor and another from ...
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
November 14, 2016, Covington Alert
On November 10, 2016, the Food and Drug Administration (FDA) released its final guidance for industry on the voluntary qualified importer program (VQIP). The final guidance builds upon draft guidance issued in June 2015, as part of FDA’s implementation of the FDA Food Safety Modernization Act of 2011 (FSMA) mandate to establish a voluntary, fee-based program to ...
November 4, 2016, FDAnews
John Balzano participated in an FDAnews webinar and is quoted in an article regarding China FDA’s proposed expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls. According to Balzano, to be eligible for the accelerated pathway for breakthrough medical devices, the intellectual property for the device needs ...
November 2016, Insight Magazine
September 29, 2016, Inspection Insider
John Balzano participated in an FDAnews webinar and is quoted in an Inspection Insider article regarding China FDA’s proposed rules that increase penalties for devicemakers that fail to issue recalls. Commenting on the agency’s “accelerated pathway” for breakthrough medical devices, Balzano says that in order to be eligible for the pathway, the devices’ ...
September 12, 2016, International Devices & Diagnostics Monitor
John Balzano participated in an FDAnews webinar and is quoted in an International Devices & Diagnostics Monitor article regarding China’s changing device regulations. According to Balzano, "Overall, they're going to want to make sure that they have a regulatory structure in place that facilitates the most innovative applications and the applications for devices ...
August 26, 2016, Global Policy Watch
Against the backdrop of a long string of product safety scandals that have eroded public trust, and a desire to transition China’s economy from an export-driven model to a consumption-driven model, the Chinese government continues to enhance its legal framework for the protection of consumer rights. On August 5, China’s State Administration of Industry and...… ...
April 25, 2016, International Devices & Diagnostics Monitor
John Balzano’s remarks from an FDAnews webinar are quoted extensively in this article on changes to Chinese device regulations. According to Balzano, it is important to consider a host of issues, such as whether the device will be manufactured in China. Understanding the finer points of the Chinese FDA guidances "can influence whether your application gets ...
November 17, 2015, Covington Alert
September 18, 2015, Covington Alert
September 17, 2015, Covington Alert
September 8, 2015, Covington Alert
June 8, 2015, Covington Alert
Covington Announces Ten New Counsel
April 10, 2015
WASHINGTON, DC, April 10, 2015 — Covington is pleased to announce the promotion of three lawyers to of counsel and seven lawyers to special counsel, effective April 1, 2015. The new of counsel are as follows: John Balzano (New York) represents companies and industry associations on U.S. and China regulatory and policy matters related to food, drugs, and ...
Regulation of eHealth Products and Mobile Apps
February 25, 2015, Covington’s Life Sciences Essentials Webinar Series
January 23, 2015, Covington E-Alert
January 6, 2015, Covington E-Alert
September 23, 2014, Covington E-Alert
September 23, 2014, Covington E-Alert
September 23, 2014, Covington E-Alert
July 29, 2014, Forbes
Covington's John Balzano writes on the safety issues with meat production in his blog for Forbes Asia. "Safety issues with the meat and meat products in China are causing controversy again. Last year a group of diseased pig carcasses came floating into rivers near Shanghai, causing concern about black markets for meat spreading foodborne illnesses. This time ...
July 18, 2014, Covington E-Alert
China's Elusive Pet Food Regulation
June 25, 2014, Forbes
Covington's John Balzano writes on Chinese pet food regulation for Forbes. "Long-term, all-too-frequent, and severe safety issues with pet treats and pet food coming from China have led to serious questions about the state of China’s pet food regulations. The answer to those questions may be fairly simple: China does not have a significant body of pet food ...
June 4, 2014, Covington E-Alert
Does China have Good Manufacturing Practices for Food?
May 16, 2014, Forbes Asia
Covington's John Balzano writes about food manufacturing in China for his latest blog post in Forbes Asia.
The Food Police: China Proposes a Plan for a Special Unit for Food and Drug Safety Violations
April 20, 2014, Forbes
Covington's John Balzano writes about a recent announcement by the China FDA and the Ministry of Public Security that China is creating a special police unit for food and drug law violations.
April 9, 2014, Covington E-Alert
March 24, 2014, Forbes
John Balzano, special counsel in Covington's food and drug practice group, writes about the regulatory enforcement of illegal sales of recycled or expired food in Chinese village markets in his latest blog post for Forbes.
March 3, 2014, Covington E-Alert
January 16, 2014, Covington E-Alert
December 24, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
Risk-based Regulation and Food Safety Risk Assessment
December 2012, Shanghai Food and Drug Administration, Shanghai, PRC; Central University of Finance and Economics, Beijing, PRC
U.S. Food and Drug Law in Comparative Perspective
July 2012, Boston University School of Law, Boston, Massachusetts
Medical Autonomy: China’s Regulatory Dilemma
February 2012, Yale University, New Haven, Connecticut
2012, 13 Asian-Pac. L. & Pol’y J. 23
2012, 38 N.C.J. Int’l L. & Com. Reg. 43
Effectiveness & Accountability in the Implementation of China’s Food Safety Law
November 2011, Yale Law School, New Haven, Connecticut
2011, 13 Or. Rev. Int’l L. 71
Food Safety Law in China
October 2010, Yale University, New Haven, Connecticut
2007, 16 Tul. J. L. & Sexuality 1
2006, 3 Loy. U. Chi. Int’l L. Rev. 187
COVID-19: Legal and Business Toolkit
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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