Certificate of Pharmaceutical Product Modernization

Dr. Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory, is back to share his insights on a recent update in the field.

Well, it is that time again. I thought I would review and comment on some recent CVM/FDA announcements, plans and new GFIs.

On December 11, 2020 the CVM/FDA announced that they will no longer be issuing the Certificates of a Pharmaceutical Product (CPP) on unique CVM paper with a gold seal. Why should we care? Well, for those companies that export products around the world, this will expedite their processes greatly. In my past life, these were essential for obtaining and keeping approvals in many foreign markets. These markets rely on CVM/FDA approval to expedite and maintain approvals in their respective countries. Allowing exporters to be able to access these certificates online and print them on their own is a major step. The World Health Organization (WHO) no longer requires CPP to be issued and hard printed on unique paper, or ribbon and gold seals to be attached to CPPs. From this point forward, all CPPs will be printed on regular office paper.  Any foreign body receiving a CPP will be able to verify certificates by using the website link found at on the certificate. See more details at https://www.fda.gov/animal-veterinary/cvm-updates/fda-launches-new-online-portal-assist-industry-exporting-animal-products.

This is as positive step forward for companies selling products outside of VICH. The amount of effort I have seen at various multi-national companies to obtain and process these certificates was substantial, as companies are typically asked by foreign governments to supply a CPP for products regulated by the FDA/CVM. The new process should help reduce the time it takes for a company to obtain CPPs. This will also simplify when obtaining multiple CPPs and allow recipients to verify the authenticity via the website, enabling faster import processing. In my opinion, this is a huge step forward in modernization of FDA/CVM processes.

By comparison, companies were previously required to submit a paper application through the mail to CVM. Once received, CVM would review the application and issue the resulting CPP back through the mail. Obviously, this was time consuming and delayed a company’s business significantly. 

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