Multiagency Electronic Regulatory Submission

MERS Project Update

July 27, 1995

The purpose of the MERS project is to develop and demonstrate an interchange standard for the electronic exchange of pharmaceutical regulatory information based on existing de jure information standards.

MERS Working Group
The MERS Working Group aims to prototype and demonstrate the submission, review, and management of a cross platform, easily archived and content accessible regulatory submission using structured document (ISO and ANSI) standards. The MERS Working Group is composed of representatives of the regulatory agencies from the Drugs Directorate of Health Canada (HPB), the Food and Drug Administration (FDA) of the USA, the Therapeutic Goods Administration (TGA) of Australia, the Medical Products Agency (MPA) of Sweden and the Medicines Evaluation Board (MEB) of the Netherlands. HPB provides project management.

MERS Project
The MERS project was initiated on January 31,1994 at a meeting between representatives of the FDA, HPB and PharmaSoft (a consultant to the MPA on IT technology) at FDA headquarters in Rockville, Maryland. Meeting participants discussed and explored common interests in the application of SGML technology to the development of an international standards-based electronic submission. SGML is an international standard for electronic document interchange (ISO 8879, US Federal Information Processing Standard FIPS 152, Canadian Treasury Board Standard TBITS-14). The Quality (Chemistry and Manufacturing, CMC) section of the submission was identified as the initial part of the submission to prototype since the Quality section is technically complex and relatively compact.
A draft data model was developed at the working group meeting held in Ottawa, Canada in October of 1994. Four meetings have been held since October 1994 between the participants to develop, define and refine the necessary Document Type Definitions (DTDs) for the development of a non-proprietary SGML- based Quality submission, with InfoDesign (USA, Canada) and PharmaSoft (Sweden) providing technical expertise.

Current Status
At the working group meeting hosted by the MPA in Uppsala, Sweden, July 24-27,1995, the draft data model was further refined and a prototype DTD was prepared. This prototype DTD will be tested with simulated regulatory submissions. This prototype solution will be completed in 1995/96 and tested across multiple environments to assure cross-platform / software portability and implementation independence. The outcome of this phase will provide essential experience for prototyping DTDs for the clinical and safety sections.

For more MERS Information E-mail to:
Dr. Bob Kapitany, Health Canada
Dr. Carl Berninger, US FDA

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