Understanding the role of the FDA in the importation of pharmaceutical products

The United States Food and Drug Administration (FDA) plays a vital role in safeguarding public health by regulating a wide range of products, including drugs, biologics, medical devices, and more.

While these products may be manufactured domestically or internationally, they all must meet stringent safety and efficacy standards set by the FDA.

The FDA's Office of Regulatory Affairs (ORA) Office of Import Operations (OIO) lead the FDA's import program and ensure that all products entering the US market are safe, effective and in accordance with the applicable regulations.

In this process, it is essential to recognize that the term ‘importer’ refers to any entity acting as the importer of record for a given shipment.

When an FDA-approved product is manufactured overseas and imported into the US, it must pass through Customs and Border Protection (CBP), all products regulated by the FDA are referred by the CBP to the FDA for an admissibility evaluation upon importation, . This process ensures that imported products adhere to the same regulatory standards as those produced within the US.

To facilitate FDA review, importers are required to provide specific information about the shipment via the Automated Commercial Environment (ACE) system, which assigns an entry number for tracking purposes.

The submitted data should include mandatory and optional supporting details necessary for the FDA to determine whether the shipment complies with relevant regulations. Additionally, importers should consult the FDA Supplemental Guide to ensure that all data is provided, and applicable criteria are met.

If the submitted information is complete, accurate, and raises no concerns, the FDA will release the shipment.

However, in some instances, the FDA may decide to physically inspect or sample the product to confirm compliance with applicable regulations.

Additionally, if the provided data is found to be insufficient, the FDA will contact the importer for clarification and, should the importer's response satisfactorily address the FDA's concerns, the shipment will be released.

In cases where the importer's response is deemed inadequate, the shipment may be forwarded to the FDA compliance office. A compliance officer could then detain the shipment and issue a notice of action (NOA) to the relevant parties. To obtain release approval, the importer must address the FDA's questions sufficiently. Based on the assessment, the compliance office will either release or refuse the shipment. Refused products must be exported or destroyed within a specific period.

In summary, the FDA plays a crucial role by enforcing strict safety and efficacy standards, ensuring that imported products meet the same regulatory requirements as those manufactured domestically within the United States.

Through the thorough import review process, the FDA confirms that importers stay compliant with relevant regulations and that the imported products are safe for human consumption.

Author Bio – Manan Shah

Manan Shah is a Senior Manager of Regulatory Affairs at G&L Healthcare Advisors.

Most recently, he has been responsible for assisting clients with the COVID-19 vaccine strategy in development and commercial aspects.

Manan has a thorough understanding of regulatory requirements and has successfully navigated many companies through the regulatory challenges associated with CMC, and FDA import compliance and submissions. With his expertise and experience, Manan is committed to advancing the development of innovative drugs and biologics that improve patient outcomes.

G&L Healthcare Advisors provide industry-leading advice, guidance and support for clients working with global Health Authorities, including the FDA. 

To find out how we can support you, contact Manan at: mshah@gandlhealth.com