On July 15, 2015 the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) published “Data Standards Strategy 2015-2017” [DC1] as a revision to the originally created strategy in 2012. The document states that the goal, which is to ensure ongoing commitment to development, implementation, and maintenance of data standards to facilitate regulatory review, follows three principles:
- Ensure high-quality data standards
- Reduce burden of regulation through alignment with regulations
- Ensure efficiency of data standards through adoption and adaption
Incidentally, these principles and goals are shared across Life Sciences. Sponsors and vendors all strive to have continuity within their organizations, across product lines, throughout product lifecycles. But the pièce de résistance is when the regulatory agencies and sponsors come together in alignment to reach these goals.
This alignment and acceptance of standards across regional and organizational boundaries is primarily due to the efforts of organizations such as the International Standards Organisation (ISO), Health Level 7 (HL7), International Conference on Harmonisation (ICH), Coalition for Accelerating Standards and Therapies (CFAST), and the list goes on. Additionally volunteers across industry in groups such as IRISS, DIA, and PhRMA to name a few, work together to collaborate on implementation of these standards.
The “Data Standards Strategy 2015-2017” lays out the strategic approach to standardization for Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ADNAs), all products that fall within CDER/CBER jurisdiction. These standards fall into five categories:
- Drug Development and Pre-Market Review
- Drug Safety Performance and Promotion
- Pharmaceutical Quality
- Planning and Governance
These standards such as IDMP are driving industry change and leading to a push for overall Master Data Management (MDM). IDMP is expected to be final on July 1st 2016. EMA has announced that they will require product information in compliance with IDMP on that date. The US-FDA is expected to follow suit by 2018. While these dates may flux between now and then, potentially allowing some additional time to prepare, it is still a huge undertaking. Cataloging all this data, correlating it to the respective standard, and finding the gaps lost in excel sheets, desktops, and paper filings. The industry and agencies have been preparing and moving towards standardization since 2001. Structured Product Labeling (SPL), eCTD, and CDISC have all been pushing standardization and adoption of these standards.
At Paragon, we recognize that these standards which drive industry changes can also place a burden on the individuals within organizations to educate, implement, and remain in compliance while still maintaining day to day job functions. We’re committed to working with volunteer groups, standards organizations, and vendors to evaluate and collaborate on the best practices and processes for change in order to alleviate that burden.
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- Standardized study data required for all clinical and non-clinical studies that start on or after December 17, 2016 (December 17, 2017 for INDs) per section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) – Providing Regulatory Submissions in Electronic Format – Standardized Study Data Guidance for Industry, December 2014
- All submissions to the FDA for NDAs, ANDAs, BLAs, INDs to CDER or CBER must be submitted in electronic format by May 5th 2017 per Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, May 2015
- Inclusion of Ad/Promo information in eCTD Module 1 format per FDA Form 2253 Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry, Draft April 2015
The views stated in this document are not representative of the FDA or any of the other organizations mentioned in this blog.