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The U.S. Food and Drug Administration (FDA) and regulators in numerous other countries are increasingly focused on ensuring “good practice” in the development, manufacturing, and marketing of products. The underlying quality regulations and guidelines are collectively known as “GxPs.” Those practices include good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), good pharmacovigilance practice (GVP), and good distribution practice (GDP), among others. These regulations set minimum standards for that companies must meet to insure that their products are of suitable quality and are safe and effective for human consumption.

Increasing International Regulation and Enforcement

Regulators have for many years imposed their standards of GMP on facilities in other jurisdictions, but the proliferation of mutual recognition agreements, such as that between the U.S. and the EU that has recently taken effect, mean that what appear to be local GMP issues can quickly become international. Local breaches of GLP and GCP can mean that the results of non-clinical and clinical studies become ineligible for submission to regulators in any jurisdiction. The need for companies to comply with differing standards of GVP applied extra-territorially is also a growing challenge.

Covington’s Capabilities

We advise clients on:

  • Discovery of Non-Compliance with GxPs, including determining whether the company has a legal obligation to carry out an investigation and/or self-report
  • Handling routine and triggered GxP inspections, including:
    • creating procedures for handling GxP inspections;
    • providing GxP inspection training for relevant company personnel; and
    • responding to inspection findings.
  • Enforcement actions, including seizures of adulterated products
  • Product recalls

Covington is one of the only firms that regularly advises life sciences, food, and cosmetics companies on the legal and regulatory impact of GxP requirements in a number of key jurisdictions, from the U.S. to Europe and Asia.

Our U.S. team includes senior former FDA officials with experience in the Office of Compliance in the Center for Drug Evaluation and Research (CDER) and the Office of Manufacturing Quality (OMQ).

In Europe, our lawyers in London, Brussels, and Frankfurt have deep experience advising clients on EU and national laws governing GxP issues. They have participated in formal and informal GMP, GCP, and GVP regulatory and enforcement proceedings before the European Medicines Agency (EMEA), national authorities and in the courts. This has included the successful defense of a major pharmaceutical company in the first financial penalties infringement case bought by the European Commission for alleged breaches of EU GVPs.

Our China food, drug, and device regulatory team based in New York and Shanghai has advised numerous companies on China GxP issues concerning a wide range of products, including infant formula, general and health foods, drugs, medical devices, and animal foods and drugs. For example, we have advised on various aspects of drug and medical device clinical trial, good manufacturing practice, and good supply practice inspections and self-inspections, as well as on establishing food and health food manufacturing operations. We also have experience integrating China-specific content into global standard operating procedures.