Coordinated Implementation of Electronic Submissions Requirements Would Improve Review of New Medicines

Streamlining Technical Requirements Would Advance Global Drug Development

05.12.14 | By Kristin Van Goor

Using new authority granted by the Food and Drug Administration Safety and Innovation Act (FDASIA), the Food and Drug Administration (FDA) issued draft guidance that, when final, will be binding upon industry to submit information to the Agency in specified formats and standards.  With the issuance of this draft guidance, industry and FDA have taken a big step forward towards a fully electronic review environment, which is intended to improve the quality and efficiency of FDA’s review of new medicines.

A more efficient and higher quality review is clearly in the best interest of patients. Many pieces must fit together to achieve this goal – industry must adopt and use consistently specified data standards, software and technology used in clinical trials must be updated to capture data in specified formats, industry and FDA must be able to process and analyze data in these defined formats, and FDA must be prepared to accept and interpret standardized data.  Putting the pieces together requires coordination across many stakeholders groups: those who develop standards (standards development organizations such as the Clinical Data Interchange Standards Consortium), vendors that develop software and systems for electronic data capture in clinical trials, biopharmaceutical industry that must test and validate the software and systems and keep pace with evolving data standards, and regulators (including FDA) that must also maintain systems and processes for receiving and reviewing standardized submissions from industry. 

Robust Cyber Security Measures Needed for Protection of Electronic Information
As all stakeholders work together to achieve the shared goal of a drug development and review process that leverages technology and standards to increase quality and efficiency, we must also keep in mind the importance of protecting these data that are transmitted and stored electronically.  As the FDA implements their new authority to require standardized, electronic submissions, it is of critical importance that robust cyber-security measures are in place to protect those data that FDA receives and stores.

Harmonization of Timelines for Implementation of Technical Requirements Would Advance Global Drug Development
It is also important that the requirements for use of data standards and specified submission formats do not have an unintended, negative impact on drug development or regulatory review timelines.  PhRMA’s members are global companies that seek to develop innovative medicines for patients around the world.  In pursuing global development programs for innovative medicines, it is important that technical requirements (such as the use of a particular data standard or format) by one regulatory authority are not in conflict with the requirements or expectations of another regulatory authority. 

Ideally, requirements for use of particular data standards and formats would evolve as standards are mature, widely adopted, and accepted by all major regulatory authorities.  The true benefit of use of specific standards and formats for submission of new drug applications comes with consistent, predictable use of those standards by both industry and regulators.   

With a deliberate, predictable, and coordinated approach to implementation of electronic submissions requirements, patients around the world could benefit.

For more information, please see the comments filed jointly by PhRMA and the Biotechnology Industry Organization (BIO) on FDA’s draft guidance on electronic submissions requirements.  


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