Best Practices for Pharma Trade Compliance Teams
Trade compliance professionals in the pharmaceutical sector must deal with considerably more regulation than many other industries. In addition to U.S. Customs and Border Patrol (CBP), pharmaceuticals are subject to import requirements of several other government agencies, such as the Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). Pharmaceutical trade compliance professionals can proactively manage this added complexity in several key ways.
Understand your Products
To properly determine the regulatory requirements applicable to your company’s products, it is important to thoroughly understand their characteristics. The data and documentation required for submission at the time of importation depends on attributes such as whether or not a product is approved, how it is packaged, its intended use, and the components it contains. For example, an FDA approved drug that is packaged ready for use does not require an APHIS import permit. An unapproved placebo capsule shipped in bulk that contains the animal derived component, such as gelatin or lactose, does need an APHIS import permit. However, if lactose is the only animal derived ingredient in the product, a permit is not required if a written confirmation on the manufacturer’s letterhead is presented. Knowing product attributes helps you understand what data and documentation need to be provided at the time of importation, and when a product may be exempt from a requirement. Take time to develop relationships with people in areas such as purchasing, manufacturing, R&D, and clinical trials management who are sources of this vital information.
Additionally, it will be easier to explain to colleagues in other departments, such as R&D, clinicals, or manufacturing, what is required to move materials internationally so that they can adequately prepare and plan ahead of time. The last thing you want to deal with as a compliance professional is a shipment detained at the U.S. port of entry because an APHIS permit wasn’t obtained.
Proactively Maintain Regulatory Data
Once you understand the regulatory requirements for your company’s products, you can more easily develop a process to collect and maintain this data proactively so that is readily available at the time of entry. A best practice is to maintain data such as NDA, IND or BLA numbers, FDA product codes and NDC number in a product database in an ERP or automated global trade system (GTS). If this is not an option, an Excel spreadsheet can serve as a your “database” if your product assortment isn’t overly large and complex. Having all regulatory data and requirements in one place provides a single source of truth from which to pull information to give to your customs broker to submit on the import declaration. This also ensures that data submitted to FDA for each import is consistent and matches FDA’s system each time, leading to quick release and reduced delays and detentions.
Work Closely with your Regulatory Group
While you may know what the regulatory requirements for your products are, you may not completely understand what they mean. What exactly is an NDA, IND, BLA, FDA product code or NDC number? Why are they necessary for import, and what do they tell FDA? Your regulatory group is the key to helping you understand these terms. Ask them for training because they are integrally involved in managing regulatory requirements, especially FDA, applying for approvals and registrations, maintaining, and updating them. A deeper knowledge of regulatory terms and acronyms helps you better understand the language FDA uses on inquiries and notices of detention so that you can respond quickly with the correct information in case of an issue. For example, if FDA issues a detention notice stating the NDC code was missing from the data set submitted by the broker, you’ll understand exactly what that is and be able to respond quickly to FDA with the right information to get the product released. No time is wasted going back and forth multiple times trying to understand what FDA is requesting. You’ll also know exactly where to find it – in the database you just created.
Keep up to Date on Regulatory Requirements
Regulatory requirements change constantly. Therefore, it is important to keep up to date on all the other government agency requirements affecting your products. Great ways to keep current include subscribing to agency updates and newsletters available on their websites, reviewing federal register notices announcing new regulations for the agencies that are key for your company, downloading the latest versions of guidance documents many agencies publish on their websites, and participating in industry trade organizations where you can network with, learn from, and exchange information with other trade compliance professionals in the pharma industry. In addition, attending conferences and webinars sponsored by trade organizations and service providers also keeps you abreast of the latest developments. Many of these webinars feature agency officials as speakers. You’ll stay ahead of changes and give yourself the time to adapt your data and processes to proactively prevent problems.
While there is much added complexity for trade compliance professionals in the pharmaceutical industry, there are many ways to be smart about how you manage it.
