HL7 Version 3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2

DESCRIPTION

The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry, and between sets of regulators. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between parties. This message is designed to be flexible enough to be used to support regulatory exchanges for any regulated product.

ALTERNATIVE NAMES

HL7 Version 3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 may also go by the following names or acronyms:

TARGETS

• Regulatory agencies
• Pharmaceutical and Medical Device industry
• Pharmaceutical Vendors
• Document Management and Publishing Vendors

BENEFITS

• Provides healthcare regulatory authorities a single message specification to manage the entire spectrum of regulated product submission types
• Supports existing and future electronic regulatory product submissions to enable exchange between Regulators and Regulated Industry

IMPLEMENTATIONS/CASE STUDIES

• ICH – eCTD v4.0 will use RPS as the underlying technical standard to regulatory product submissions for biopharmaceuticals

DEVELOPMENT BACKGROUND

Regulatory Authorities (hereinafter referred to as Regulators) exchange information with the regulated industry (hereinafter referred to as Industry) and each other to address a variety of regulatory issues. The information included in these regulatory exchanges can be provided in paper or electronically in the form of digital files. Frequently, the new information is directly related to information previously provided. Because information is submitted over time, often in increments, it is difficult to efficiently process and review the new information in light of pre-existing information.

The goal of the Regulated Product Submission message is to facilitate the processing and review of electronic regulatory submissions. Accordingly, the Regulated Product Submission Refined Message Information Model (RPS RMIM) captures all information required for the efficient processing and review of electronic regulatory submissions.

Different regulated product types (e.g., devices, medicinal products) specify different hierarchical constructs (i.e., tables of contents) to organize the information provided in the regulatory exchanges. However, the basic requirements for submitting information electronically over time are the same. Therefore, the objective of the Regulated Product Submission message is to define one message structure that can be used for all regulated products. The message standard is intended to be used worldwide, to support the review of regulated products including, but not limited to, foods, medical devices, human therapeutics, and veterinary medicines. It is important to note that the wide range of products that is contemplated leads to providing a generic structure for the actual specification.

RELATED DOCUMENTS

	HL7 Version 3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2		(Download) (47.08 MB)
	Version 3 Implementation Guide: Regulated Product Submission, Release 1	(View Brief)	(Download) (271 KB)

ADDITIONAL DETAILS

This standard is available in the HL7 2015 Normative Edition. The 2015 Normative Edition is also available online to members.

TOPICS

• Public Health
• Regulated Products
• Regulated Studies

BALLOT TYPE

• Normative

STATUS DATE

2020-07-27

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• ANSI-approved

STAKEHOLDER

• Pharmaceutical Vendors

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal