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Navigating regulatory landscapes

A guide to global submission standards

In the intricate landscape of pharmaceutical development and regulatory approval, adherence to stringent technical specifications and data standards is paramount. From ensuring compliance with US Food and Drug Agency (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) guidelines to navigating industry standards and addressing conflicts between regulatory and industry documents, drug sponsors face a myriad of challenges in preparing data for submission.

In a recent webinar, ICON’s experts delved deep into the nuances of FDA and PMDA technical specifications and data standards, providing essential insights for drug submissions. This blog summarises the key insights and recommendations shared in the webinar, offering a guide for pharmaceutical stakeholders navigating the complex terrain of regulatory submissions.

Understanding Regulatory Data Standards

Accurately interpreting regulatory data standards is crucial for submission preparation. Misinterpretation or non-compliance with these standards can lead to delays, rejections, or requests for additional information from the regulatory agencies, prolonging the approval process for new drugs and therapies. By understanding and adhering to regulatory data standards, sponsors can streamline the submission process, enhance data quality, and facilitate the agency’s review and evaluation of submitted data. 

Two key documents that describe FDA data standards requirements are the Data Standards Catalog and the Study Data Technical Conformance Guide, which are both referenced by FDA binding guidance documents. The Data Standards Catalog is a valuable resource showing which versions of data standards are accepted by the agency. The Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardised study data as defined in the Data Standards Catalog.

Similarly, the Japan PMDA also has a Data Standards Catalog and a Technical Conformance Guide. The PMDA Data Standards Catalog bases “Date Support Ends” on the date of the submission, while the FDA bases it on the date of study start. The PMDA Technical Conformance Guide includes a preference for receiving Analysis Results Metadata (ARM), which the FDA document does not.

Understanding the similarities and differences between FDA and PMDA data standards requirements is essential for sponsors aiming to submit their products for approval in both regions. While both the FDA and PMDA aim to ensure the safety, efficacy, and quality of pharmaceutical products, their data standards requirements may exhibit variations in terminology, formatting, or specific requirements. Exploring these nuances is crucial for sponsors to align their submission packages with the expectations of both agencies.

Conducting a practical analysis of these guides can shed light on the specific data standards required by each agency, facilitating the preparation of submission packages that meet both sets of requirements. Aligning submission packages with the expectations of both the FDA and PMDA requires careful consideration and attention to detail. Sponsors must identify areas of overlap and divergence between the two sets of requirements and develop strategies to address them effectively. By harmonising data standards, terminology, and formatting conventions across FDA and PMDA submission packages, sponsors can streamline the approval process and enhance the chances of regulatory success in both regions.

Key Considerations for Successful Submissions

The Models and Implementation Guides for the Clinical Data Interchange Standards Consortium (CDISC) Foundational Standards, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Define-XML, are essential resources for sponsors seeking to adhere to standardised data formats and terminology. By understanding these documents and implementing them effectively, sponsors can ensure consistency and interoperability in their submission datasets, simplifying the review process for regulatory agencies.

Both regulatory agencies and CDISC also provide validation rules to help sponsors identify and address potential issues in their submission packages. By conducting a detailed examination of validation rule violations, sponsors can proactively address any deficiencies and ensure that their submissions meet the agency’s standards requirements. 

Additional resources that provide details for FDA submission requirements include the CDISC Therapeutic Area User Guides (TAUGs); the PHUSE templates: Study Data Standardisation Plan (SDSP), Clinical Study Data Reviewer's Guide (cSDRG), and Analysis Data Reviewer's Guide(ADRG); and the FDA technical specifications.

Adhering to regulatory standards is paramount for ensuring smoother review processes and expediting the approval of pharmaceutical products. By aligning their submission packages with FDA and PMDA requirements, sponsors can minimise the likelihood of technical rejections and delays, accelerating the path to market for their products.

Watch the full webinar for a comprehensive overview of the diverse requirements and guidance on interpreting the FDA and PMDA data standards.

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