Global regulatory agencies are setting time-lines for conversion of paper Drug Master Files (DMFs) to electronic “eCTD” format. Health Canada went into effect March 31, 2016. The US FDA is scheduled to go into effect May 2017. No health authority will grant exemptions from the mandate and respective deadlines.
Compliance of eCTD submissions is validated with international standards and agency guidances. Validation failure results in the DMF being rejected, and requires correction (remediation) and resubmission until validation succeeds.
Many excipient manufacturers lack the resources and expertise to convert their DMFs into eCTD format. Based on an IPEC-Americas member poll in Q1, 2016, it was determined that IPEC-Americas should explore negotiating lower rates for eCTD services with 3rd party eCTD vendors (e.g. both for services and for software).
The ground work is now complete, and several vendors have expressed interest in working with IPEC-Americas member companies. The services of each of these companies varies, and IPEC-Americas is not endorsing any one particular company, and has not vetted or evaluated any of the vendors. However, if your company needs a list of service providers to assist with the eCTD conversion process, regardless of what stage you are at in the process, IPEC-Americas can help. Don’t wait until 2017 to meet this requirement, now is the time to get your DMFs converted and your gateway established!
Contact IPEC-Americas staff at firstname.lastname@example.org for a list of companies, services, points of contact and discounts.