From Food to Pharma: growth opportunities in the United States

FDA submissions of Type III DMFs open up new pathways in the US for food packaging manufacturers

Cristina Sancolodi – Scientific Client Relationship Manager, Food & Food Contact Materials Division, Knoell. Member of Aibo-FCE

The pharmaceutical packaging sector represents a highly attractive growth opportunity for companies currently operating in the food contact materials industry. Through the strategic submission of Type III Drug Master Files (DMFs) to the United States Food and Drug Administration (FDA), food packaging manufacturers can leverage their regulatory expertise and in-depth materials knowledge to secure a significant share of the pharmaceutical packaging market. In 2024, this reached a global value of USD 151.5 billion, with growth expected to exceed 15% by 2034.

What are FDA Type III DMF authorisation requests?
A Type III DMF allows packaging or packaging component manufacturers to submit confidential and proprietary information directly to the FDA, without disclosing it to their clients – the pharmaceutical companies. A Type III DMF typically includes details on the composition, manufacturing process, specifications, and stability of a packaging material, along with supporting data demonstrating its suitability and safety for contact with food. It can cover packaging and components such as bottles, closures, caps, blisters and any that comes into direct contact with pharmaceutical products.

The main advantage lies in the confidential nature of DMFs. Food contact packaging or component manufacturers can safeguard their intellectual property while simultaneously providing the FDA with the full technical data needed to demonstrate regulatory compliance and safety for food contact. Pharmaceutical companies benefit from being able to reference these DMFs in their marketing authorisation applications without needing access to the confidential details. This system provides food packaging manufacturers with a competitive edge, effectively fostering preferred partnerships with their pharmaceutical clients.

Leveraging food contact materials expertise for the pharmaceutical market
Food packaging manufacturers bring a number of inherent advantages when entering the pharmaceutical packaging market, as the regulatory frameworks share significant similarities while maintaining their specific requirements. Many companies have already developed expertise in ensuring compliance of raw materials and finished products with US food contact regulations, giving them a strong advantage in preparing the information required for Type III DMF submissions.

The DMF submission process
The DMF submission process begins with a request for a pre-assigned DMF number from the FDA, a mandatory requirement before submitting any technical content. Companies may also engage a consultancy to obtain this number, which serves as a unique identifier throughout the entire submission process.

At the same time, companies must have access to the FDA Electronic Submissions Gateway (ESG), the mandatory transmission system for all DMF submissions since May 2018. The FDA’s ESG serves as the central transmission point for electronically sending information to the FDA. It receives the submissions, acknowledges their receipt, routes them to the relevant FDA centre or office, and notifies the sender of delivery. The FDA’s ESG does not open or review the submissions.

Electronic submissions of Type III DMFs must comply with the eCTD (Electronic Common Technical Document) format and specifications. The eCTD is the mandatory digital file format companies must use to submit DMFs to the FDA, replacing paper submissions. It is a standardised electronic structure based on an XML architecture, which consistently organises PDF documents, allowing FDA regulators to access and review the information efficiently. Submissions that are not filed electronically, as well as electronic submissions that do not comply with the required format, are neither accepted nor archived.

The ESG registration process involves several stages, including account creation, testing phases, and validation of submission capabilities, which may take several weeks to complete. For this reason, the FDA recommends that companies start well in advance of the intended submission date.

Companies without an ESG account may engage a consultancy that already has an account and experience with submissions.

Once submitted and accepted by the relevant FDA centre, the FDA conducts a completeness check. This review is purely administrative, ensuring correct formatting and that all required sections are present. It is not a scientific evaluation of the packaging’s safety or suitability.

A technical review of the information only occurs when a pharmaceutical company references the DMF in its marketing authorisation application for a drug via a Letter of Authorization (LoA).

Letter of Authorization: enabling third-party reference
The Letter of Authorization (LoA) mechanism allows pharmaceutical companies to reference the information contained in their packaging suppliers’ DMFs without accessing confidential data. This confidential referencing system protects trade secrets while providing FDA reviewers with access to the complete technical documentation previously submitted by packaging manufacturers in a Type III DMF.

The LoA must specify the reference details, including the DMF number, the DMF holder’s name, the authorised third party, and the product name. It is important to note that each LoA authorises a third party for a specific application. If multiple pharmaceutical companies or applications with different uses are involved, separate LoAs will be required.

Should any changes or adjustments occur after the DMF submission – such as modifications to materials, processes, specifications, production parameters, regulatory updates, or similar – the DMF holder must submit a formal amendment to the FDA via the same ESG system, as previously described. This change control process may require scientific justification for such variations, impact assessments for the referencing applications, and notification to all authorised third parties.

Annual report requirements
To keep a DMF submission “active” in the FDA database, the DMF holder must submit annual reports to the FDA one year after the original submission and every year thereafter. These annual reports must include information such as any changes that have occurred since the last report and updates regarding authorised third parties. The reports provide the FDA with up-to-date information on DMF usage, ensure the holder’s commitment to maintaining the accuracy of the submission, and confirm regulatory compliance by all authorised parties.

Failure to submit these annual reports on time may result in the DMF being deactivated. Submission of the annual report is a mandatory requirement to maintain an “active” DMF.

Conclusion
Packaging manufacturers with solid experience in the food sector have significant advantages in managing the requirements of pharmaceutical packaging, making the submission of a Type III DMF a natural extension of their regulatory expertise.

Finally, as previously noted, leveraging specialised expertise during the DMF submission process facilitates compliance, ensuring that the technical documentation meets all FDA requirements while minimising the risk of delays or deficiencies. Qualified support can efficiently manage submission requirements, safeguard proprietary data confidentiality, and provide ongoing assistance through updates and communications with regulatory authorities, thereby increasing the chances for a smooth and successful submission.

https://www.gminsights.com/industry-analysis/pharmaceutical-packaging-market