Today Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ, starts with a series of articles talking about international trends in Drug Registration and Evaluation. He will provide an update on some selected topics in electronic submissions and some insight into how LORENZ will deal with these evolving regulatory requirements.
Regulatory authorities around the world continue to adopt internationally recognized data standards in an effort to improve the efficiency of their work environments and processes. The most commonly discussed data standards are the Electronic Common Technical Document (eCTD); International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP); Health Level 7 (HL7) Structured Product Labeling (SPL)-based standards for the transmission of product data, including IDMP; and Clinical Data Interchange Standards Consortium (CDISC)-based standards for both clinical and non-clinical study data.
The adoption of these standards not only allows individual national authorities to improve their own processes, but also allows for increased cooperation and information sharing among global regulatory authorities. Recently, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) expanded its membership with the addition of China’s Food and Drug Administration (CFDA), Brazil’s National Sanitary Surveillance Agency (Anvisa), and Korea’s Ministry of Food and Drug Safety (MFDS). The expectation of industry is that these authorities will move quickly to adopt relevant ICH standards.
Developed as an ICH standard in the early 2000s, eCTD is now used by the leading regulatory authorities around the world to receive drug evaluation information from regulated industry.
The eCTD provides many advantages over paper or non-eCTD electronic submissions:
- Reliable presentation of information to reviewers – reviewers can always find the same type of information in the same place as they evaluate different products or applications. This reduces the time that reviewers must spend searching for a particular piece of information and increases the speed and efficiency of the evaluation.
- Flexibility for national authorities – national regulatory authorities are free to create their own regional information section in the eCTD, including the relevant metadata and documents that are necessary for each region’s evaluation.
- Metadata for automated processing – the eCTD envelope section will normally carry information to uniquely identify an evaluation including an ID number and metadata about the type of application. This metadata can be used by systems at the national authority to automate processing, validation, and import of the eCTD message into tracking and review systems. Enabling automated processing can reduce errors and increase the speed in which reviewers are given access to information. The eCTD also contains metadata about the submission contents that can be used to mark documents for additional processing. This is important as more regulatory authorities accept, or mandate the submission of, CDISC-based standards for study data. This study data is routinely pulled from the eCTD submission and stored in other systems where advanced analysis can be performed. eCTD v3.2.2 enables this through metadata at the heading level and through the Study Tagging File (STF).
- Life cycle information on documents – the eCTD allows the creator to explicitly mark that a document has been updated with new or changed information. The reviewer receives a clear notice that documents have changed and must be re-evaluated or compared to a previous version.
- Reuse of information – modern submission management tools, like LORENZ docuBridge, allow eCTD publishers to easily reuse information in new applications for the same or for different national authorities. For regulated industry this helps to speed the application process and time to market for additional regions.
Due to these advantages and the maturity of eCTD v3.2.2 as a standard, several authorities have either made the use of eCTD v3.2.2 mandatory or have announced that they soon will. For example, as of 5 May 2017, the United States Food and Drug Administration (USFDA) only accepts eCTD submissions for the majority of their evaluation application types. The European Medicines Agency (EMA) also forces the use of eCTD for certain procedure types and Health Canada has announced that effective 1 January 2018 most of their submissions must be in eCTD format. In general, adoption of eCTD is increasing globally as new national authorities either begin accepting eCTD or larger national authorities mandate its use as the only accepted submission format for evaluation applications.
LORENZ is committed to supporting eCTD v3.2.2 for both our authority and regulated industry customers by reacting quickly to changes in national specifications. We take great pride in a history of always supporting new or changed national specifications before the revised version is required, and in time to support internal and pilot testing with the target authority. Through our reliable release schedule, every April and October, we are able to capture these regional updates and provide our customers with a dependable rhythm to plan their own upgrades, to ensure compliance with the latest regulatory requirements.
We are also committed to providing our customers with products that increase operational efficiency. The LORENZ Automator is used at leading health authorities to automate the receipt, validation, processing, and import of electronic submissions into LORENZ docuBridge and agency tracking and case management systems. On the industry side, the Automator is being used to complete repetitive error-prone processes, freeing humans to tackle more interesting and complex issues. The best example of this is the submission dispatch profile. The Automator can take a selected submission, deliver it to the appropriate authority gateway or portal, process incoming receipts and acknowledgements, notify personnel of success or failure, and archive the submission – all with the press of a single button.
Please contact us to find out how LORENZ docuBridge and Automator can improve the success of your regulatory operation. We are able to offer a solution for firms of all sizes, from our single-user workstation software, docuBridge ONE, to highly-scalable, integrated, and automated systems using our flagship docuBridge product for both submission compilation and review.