Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions and cannot be inspected prior to granting such approval. In such situations FDA intends to continue using other tools and approaches such as requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements as well as requesting records and other information directly from the facilities and other entities.1
Decisions regarding applications will be based on the totality of the information available to the FDA including but not limited to a firm’s previous compliance history and requesting records in advance of or in lieu of the audit. If a risk assessment of the firm deems that an inspection is required before the application can be approved, FDA intends to pre-announce the inspection or in some cases inform the applicant that the inspection may not be conducted before the action date if travel restrictions are prevalent in the region. If the inspection of a facility that raises such concerns has not been completed by the action date, FDA generally intends to issue a complete response.1
If you are a foreign manufacturer and received a complete response letter from the FDA for your drug approval without having FDA inspect your facility, it is important to know that FDA is expanding the use of other tools that have been proven to be effective in ensuring the quality of drug products imported to the US. These include physical examinations of products arriving at U.S. borders or product sampling and testing before release into commerce and other approaches mentioned above. FDA has the ability through its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool to focus its examinations and sample collections based on concerns of specific products being entered into U.S. commerce. The PREDICT screening has continued to adjust product risk scores as necessary throughout the COVID-19 outbreak. In addition to that, FDA continues to work with U.S. Customs and Border Protection to target products if they appear not to meet applicable standards for safety, effectiveness, or quality, to refuse admission of the product into the United States and an import alert may be issued for your product.1
We are closely monitoring the resumption of FDA’s inspections and changes in other operations during the pandemic and will keep you updated on how the changes will impact you. To find out how we can help you give us a call today at +1 248-987-4497 or email us at info@emmainternational.com
1FDA (Aug 2020) Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers retrieved on 09/09/2020 from https://www.fda.gov/media/141312/download
