ne of the key components of FDA’s regulatory oversight of the quality, safety, and efficacy of pharmaceutical products, both domestically and internationally, is the issuance of Certificates of Pharmaceutical Product (CPP), which are critical in the approval process for pharmaceuticals entering foreign (e.g., non-US) markets.

In recent years, FDA has adopted the electronic Certificate of Pharmaceutical Product (eCPP), a digital version of the traditional hard-copy paper CPP. The transition to eCPP aims to enhance the efficiency, security, and accessibility of the certification process, reflecting the FDA’s commitment to leveraging technology to improve regulatory practices.

FDA Chief of Exports Compliance Branch CDR Cristina Dar shares how these certificates support global health by ensuring the availability of safe, quality, effective pharmaceutical products worldwide.

DIA: Could you provide an overview of the history of the US FDA issuing CPPs and explain their impact on the quality, efficacy, and safety of drugs distributed in international markets?

Cristina Dar (CD): The 1996 FDA Export Reform and Enhancement Act (EREA) was a pivotal point for the export certificate program at the Center for Drug Evaluation and Research (CDER) because EREA simplified the requirements for exporting approved and unapproved drugs. We’ve been issuing CPPs, Certificates of Pharmaceutical Products, since that time.

The eCPP is a trusted and widely recognized tool we use to certify that both approved and unapproved drugs exported from the US meet US FDA requirements. Through this tool, we facilitate global trade, make sure that compliant drugs are available around the world, and provide assurances about the integrity of the global drug supply chain. Another important aspect is accessibility: We want to make safe, effective, high-quality drugs available globally. By doing this, we are increasing access to new treatments in other parts of the world. Lastly, the eCPP is also a harmonizing tool because it promotes regulatory compliance worldwide.

DIA: FDA recently transitioned from issuing hard-copy CPPs to electronic CPPs, eCPPs. Would you explain the benefits of this transition, and the transition process itself, including adjustments made to internal procedures and workflows?

CD: In 2021, when we transitioned to issuing electronic certificates of pharmaceutical products, the World Health Organization was recommending that governments move to issuing electronic CPPs, and we took this into account.

This transition was a huge undertaking for the exports program. With this transition, we essentially created a new product. The way I think of it is to use a phone analogy: We were working with a flip phone process and needed to transition to a newer, smart phone-like process. We first identified the business needs and realized that we needed to create a more efficient process because there were many bottlenecks.

Once we identified those business needs, we translated them into IT requirements and capabilities. We incorporated user acceptance testing in these requirements to make sure that we would have everything in line before launching the electronic system. We also made sure, all along, to give the exports community ample time to prepare for the changes coming down the pipeline.

One specific impact of transitioning to this more streamlined approach and process: We used to print about 9000 CPPs a year manually. That was a very tedious process, and it sometimes resulted in us not being able to meet the 20-day timeframe mandated by federal law. By moving to issuing electronic CPPs, we cut out two giant bottlenecks:

1. One was the need to manually print eCPPs. Working with a printer to issue 9000 CPPs annually was quite a heavy lift. We no longer have to do that.
2. The other bottleneck was shipping the CPPs and relying on couriers to deliver the CPP package to the applicants. A lot of times that would result in delays because it was a variable we could not control. With electronic CPPs, an applicant receives an eMail notification with instructions on how to access and download the certificate once it is approved, and is able to access it at any time via our CDER Export Certification Application and Tracking System (CDEReCATS).

DIA: Have you found that the lessons learned in the transition to this electronic document have been applicable in other aspects of your work?

CD: I’m an engineer, so I think with an engineer’s mind. Whenever I look at a process or a program, I look at it through my analytical lens. There are a few elements that I take into account, such as consistency and reliability, and keep in the back of my mind whenever I do anything. The exports component is: We want to help make drugs more accessible. How do we make them more accessible? By having a more efficient process for issuing CPPs.

DIA: How does FDA ensure that its eCPPs are aligned with international standards and requirements, specifically with the WHO Certification Scheme?

CD: We care about harmonization, and that is why we have been voluntarily complying with the WHO scheme for many years. We choose to align with the WHO certificate scheme because, by doing so, we are able to promote harmonization and, to use a different term, regulatory reliance.

One way we continue to ensure that FDA aligns with the WHO recommendations is by maintaining reconnaissance on the WHO recommendations. For example, in March 2021, the WHO put out new recommendations for the CPP template. We quickly looked at what those entailed and got busy revising our standard eCPP template. Of course, we had to work with our IT team to make sure the new changes were in line with our business processes to continue aligning with the WHO’s CPP template. Now our eCPP is current, based on the most recent recommendations from the WHO.

DIA: What measures have FDA taken to promote and support acceptance of the US eCPP by CPP-requesting authorities?

CD: We promote and support the acceptance of our eCPP around the world by ensuring that FDA conducts engagements with foreign governments to increase information sharing and awareness of our drug export processes so that we can promote regulatory reliance. In the time that I’ve been in this position, I’ve engaged with many different foreign governments individually. We’ve provided demonstrations on how we issue eCPPs, the types of requirements that we verify in the eCPPs, the types of eCPPs that we issue based on the different drug products we have (including approved, unapproved, and over-the-counter products), and how we issue eCPPs for active pharmaceutical ingredients.

We really take a tailored approach to answering the questions that we receive from foreign governments. We also work closely with the FDA Office of Global Policy and Strategy (OGPS). They have various offices around the world, and we work with them in the different regions from which we’ve received questions. We either address those questions individually, or we coordinate presentations based on what the foreign government or the region needs.

For example, there were some concerns as to whether certain governments would accept the electronic format of the eCPP after the transition. Their main concern was the authenticity and integrity of the eCPP. We provided a demonstration on how the quick-read (QR) code on our eCPP provides security controls that meet the need of making sure that the eCPP can be authenticated.

DIA: Is there anything else you wish to share about the eCPP?

CD: We work to be forward-looking and we really want to learn about the gaps and barriers that pharmaceutical companies and the export industry face regarding trade and the accessibility of drugs that are approved here in the US and then exported to other parts of the world. We’re open to collaborating and working with them in the same way that we did with transitioning to eCPPs. We want to do the same to meet those needs.