Mon April 17, 2017

The Plastics Industry Association (PLASTICS), working on behalf of our member companies in the pharmaceutical packaging supply chain, met with the Food and Drug Administration (FDA) last year to urge them to grant waivers and/or exemptions from the electronic filing format (or eCDT) submission requirement for Type III Drug Master Files (DMFs), or at minimum grant an extension of the May 5, 2017 compliance deadline, until an electronic filing system can be developed that accommodates Type III DMFs.

The requirements for electronic submission of Type III DMFs will cause more harm for the industry. Companies that supply the pharmaceutical packaging industry, separate from pharmaceutical companies, often supply many other industries and do not have the technical resources or the infrastructure to manage this new electronic filing system, with costs ranging from $80,000 to $1.2 million per year combined for eCTD Publishing Software, Publishing Operations Support and training (80 FR 26057). Faced with the inability to continue relying upon DMFs due to the impossibility of meeting the electronic filing requirements, some companies are considering exiting the pharmaceutical packaging business entirely. This result may be contrary to FDA’s intent and may reduce the technologies available to preserve and protect pharmaceuticals, including products currently on the market.

Our letters to FDA and our meeting with FDA staff has resulted in a guidance update that provides for a one-year extension of the deadline for Drug Master Files (DMFs) to be submitted in electronic format. Our next steps will include continuing to work with the agency on alternatives to the eCTD submission format in hopes that one of these will be adopted prior to the new May 5, 2018 deadline for DMFs to meet the electronic submission requirement.