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- Food, Drug, and Device
Covington’s internationally leading Food, Drug, and Device Practice encompasses the full range of pharmaceutical, biotechnology, medical device, veterinary, food and beverage, dietary supplement, and cosmetics issues. Through our offices in the United States, Europe, and China and a network of local counsel, we advise trade associations, multinational corporations, and emerging companies on a global basis. We are the only firm ranked “Band 1” for Life Sciences across Chambers’ US, UK, Europe, China, and Global surveys.
In the United States, we represent pharmaceutical, biotechnology, and medical device clients on matters spanning the product life cycle, from product development and clinical trials, through the FDA premarket review process, to postmarketing compliance, including adverse event reporting, Good Manufacturing Practice (GMP) and Quality System requirements, and sales and marketing. We also advise clients on complex issues relating to Hatch-Waxman, biosimilars, and orphan products. As a result of our long and deep work in the area, Covington lawyers have extensive knowledge of the governing laws and regulations, broad-based practical experience with their application, and an intimate knowledge of government regulators and enforcement authorities.
We assist clients in all aspects of food and beverage product development, safety, labeling, and promotion, and have played a key role in the most important legislative developments in the food arena, including advising clients on every new FSMA rulemaking and FDA guidance issued to date. We also have a preeminent regulatory practice relating to veterinary pharmaceuticals, veterinary biological products, pet food, and animal feed. We advise the principal trade association and numerous companies on regulation of cosmetic products.
Our London and Brussels offices include more than twenty-five lawyers who are qualified in various European Union (EU) member states and speak the main languages of the EU. We advise clients on the full range of issues involving pharmaceuticals, biotechnology, devices and diagnostics, foods, cosmetics, and borderline products. We advise on life cycle management planning, pharmacovigilance, EMA transparency policies, and the classification, conformity assessment, and CE marking of medical devices in Europe. We participate in pricing and reimbursement proceedings, including appeals against negative recommendations by the UK’s National Institute of Health and Clinical Excellence, and have in-depth expertise in the EU chemical regime (REACH), which has a significant downstream impact on consumer and health products.
We handle regulatory matters before the European Commission, the European Medicines Agency (EMA), and national regulatory agencies in the European Union. We have actively participated in the development of key pharmaceutical legislation in Europe, and we represent clients in connection with new legislative and regulatory initiatives, including new Medical Device Regulations, Clinical Trials Regulation, Transparency Directive on pricing and reimbursement, and legislation on information to patients.
Our China regulatory team plays a significant role in the firm’s global practice. Our attorneys in Asia and the United States regularly counsel national and multinational companies on the regulatory requirements of the China FDA and provincial FDA authorities. We advise on major developments in the law, regulation, and policy-making processes, including changes to the regulatory frameworks governing food safety, medical devices, pharmaceuticals, and cosmetics, and assist with regulatory advocacy during the notice and comment process before the China FDA.
Nidek ITC Section 337 Investigation
Representation of Nidek in the ITC Section 337 Investigation: Excimer Laser Systems for Vision Correction Surgery and Components Thereof and Methods for Performing Such Surgery, Inv. No. 337-TA- 419 (Respondent).
China Biopharmaceutical Regulatory and Legal Strategy
Counseling leading multinational biopharmaceutical company in doing business in China, including setting and executing on the regulatory and legal strategies for engaging in drug R&D, manufacturing, and sales and marketing.
China Device Regulatory and Clinical Trial Advice
Advise large device company on regulatory requirements for clinical trials of medical devices in China.
China licensing and collaboration
Advising a leading multinational pharmaceutical company on its agreement with a Nasdaq-listed drug manufacturer to develop and market its linaclotide capsule in China.
China licensing and joint venture
Advising a U.S. biotech company on its sino-foreign joint venture with a Chinese life sciences company to focus on RNAi-based drug discovery, and related license agreement.
China life sciences transactional
Advising a leading multinational pharmaceutical company on the acquisition of diabetes drug assets in China and the transfer of related employees from a multinational drug company.
China life sciences transactional
Representing a leading U.S. pharmaceutical company to set up a joint venture in China with a Chinese biotech company to research, develop and commercialize a late-stage clinical product for the Asia market.
China Medical Device Acquisition Due Diligence
Conducting due diligence on China device regulatory matters for a large multinational device company’s acquisition of a large Chinese device company.
China pharma bribery investigation
Representation of a major pharmaceutical company in its response to a Chinese government commercial bribery investigation in China.
China Regulatory and Compliance
Conducting internal investigation on behalf of a multinational pharmaceutical company into whistleblower allegations of corruption at its Chinese subsidiary.
January 2021
Recapture of Excess COVID-19 Payroll Tax Credits Addressed in New Regs 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 ...
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 ...
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 ...
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.
Asia's Complex Compliance Landscape
July 8, 2019, Pharmaceutical Executive
Eric Carlson spoke with Pharmaceutical Executive about the compliance challenges prevalent in the Asia-Pacific region. On the emergence of general compliance in the region, Mr. Carlson says, “When I first moved to Beijing in 2008, there were only a couple of dozen people who had compliance on their business card. It just wasn’t a job in China then. Ten years ...
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 ...
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.
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 ...
July 11, 2017, Medtech Insight
Medtech Insight references an Inside Medical Devices blog post in an article regarding the impact of China's draft circulars on medical device manufacturers. According to Covington's post, the four proposals represent important reforms to the existing drug and medical device regulatory regimes, and are intended to reduce obstacles that have delayed the launch of ...
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 ...
China to slash drug distribution groups in price drive
February 19, 2017, Financial Times
Eric Carlson is quoted in a Financial Times article regarding an initiative by the Chinese Government to reduce marked-up prices and corruption in multi-tier distribution chains of pharmaceuticals, known as the “two invoice reform.” According to Carlson, the crackdown on small distributors would accelerate sector consolidation, “centralising distribution in a ...
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 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 ...
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 ...
November 12, 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 ...
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 ...
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.
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.
- The only firm recognized by Chambers as a “Band 1” firm for Life Sciences across their U.S., UK, Europe, China, and Global surveys.
- Awarded “FDA Law Firm of the Year” by U.S. News & World Report in 2015, "Life Sciences Practice Group of the Year" by Law360 in 2012, 2013, 2014, 2015, 2016, 2019. and 2020, and "Compliance Practice Group of the Year" by Law360 in 2020.
- Recognized as a leading food, drug and device regulatory firm by Chambers, Legal 500, Law360, and LMG Life Sciences.
- More than a dozen individual attorneys recognized for excellence in food, drug, and device regulatory work by the leading legal industry surveys.
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