1. Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Jason.Kerr@gilead.com
Historical Timeline
Regulatory ImpactWHO Guidelines
1906 - No exportation restrictions from FDA
1938 - FDA implemented definition of drugs and ceased
exports
1986 - Export regulations hindered from globalization
1996 - FDA executes Export Reform and Enhancement
Act (EREA) to allow exportation
1998 - World Health Organization establishes guidelines
CPPs are critical documentation for many global
regulatory filings for drug products in countries without a
rigorous drug regulatory authority infrastructure.
Requirements
Certifying (exporting) country - “USA”
Requesting (importing) country - “Mongolia”
Name, pharmaceutical form, and composition of product
“Harvoni® (ledipsavir 90 mg/sofosbuvir 400 mg)
tablets”
Information on registration and marketing status
“Harvoni® tablets are approved and are currently
marketed in the United States”
Include current product information
“Approved shelf-life for Harvoni® tablets is 24
months and should be stored below 30C”
Gilead prepares a cover letter with NDA number and information
about market approval and manufacturers to the FDA.
Gilead also includes the original NDA approval letter with the
documentation.
Gilead provides two sets of attachments to the FDA, one for the
country and one for FDA’s records.
Attachments include: Formulation Composition, Bottle Label, and
Package Insert.
Gilead pays $175.00 for certificate application.
Regulatory Affairs: Application Process of
Certificate of Pharmaceutical Product (CPP)
Jason KerrSummer Intern Session
August 2015
FDA receives certificate application.
FDA can take up to 20 government working days to respond
Returned due to missing information
Rejected due to manufacturing facilities not to cGMP
compliance
Denied due to drug product not compliant with regulations
Accepted
FDA will then fill out a certificate with an official ribbon and send
it back to Gilead with an expiration of 24 months.
Acknowledgements
Special thanks to the Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC): Erin Watson, Michael K. Lee, and Denise Aycox.
Mongolia receives CPP and begins reviewing the drug
application.
Mongolia will send an approval letter to Gilead.
Gilead will ship drug product and distribute prescription
drugs throughout the country.
With a globalizing economy, Ministry of Health (MoH)
require a more efficient means of receiving essential
information systematically regardless of country of
origin.
Countries lacking a strong regulatory infrastructure
heavily rely on CPPs for their submission.
CPP’s ensures that imported products are made at
cGMP facilities.
Whenever possible, the importing country will verify
drug standards with their own national laboratories.
Application Process
Gilead decides to
market product to
Mongolia, which
requires a CPP in their
submission filings
FDA produces official
certificate and sends it
back to Gilead
Gilead prepares proper
documentation for the
FDA
FDA processes and
verifies applicant’s
information
Once submission is
ready, Gilead submits
CPP to Mongolia’s
submission for approval
Timeline
If required, the
certificate is sent to the
Mongolian embassy for
authentication