THE OECD GLOBAL HARMONIZED SUBMISSION TRANSPORT STANDARD (GHSTS) PROJECT

Transcription

1 THE OECD GLOBAL HARMONIZED SUBMISSION TRANSPORT STANDARD (GHSTS) PROJECT May 2014

2 History Pesticide Regulatory Process and IT Requirements Duplicate efforts by industry to meet various authority needs Numerous ways for registrants to submit their applications Paper, electronic, or combination of both Structured data for IUCLID (International Uniform Chemical Information Database) Or Unstructured Document centric data depending on requirements of regulatory authority

3 History (2) Last two decades agencies have put in place a number of different methods for submission CADDY (Computer Aided Dossier and Data Supply) and *IUCLID in the European Community E-Index (electronic index) / e-prs (Electronic Pesticide Regulatory System) in Canada PRISM (Pesticide Registration Information System) in the United States *currently supporting industrial chemicals and biocides

4 Current Situation Company 1 Compilation Tool 1 Authority A Import & viewing tool A Company 2 Compilation Tool 2 Company 3 Compilation Tool 3 Authority B viewing tool B Authority C Import & viewing tool C Joint Review Company 4 Compilation Tool 4 Authority D Paper and viewing tool D Incompatible deliverables - Challenging communication and process management between stakeholders

5 Goals (1) Company 1 Compilation Tool 1 Authority A Import and viewing tool A Company 2 Compilation Tool 2 Company 3 Compilation Tool 3 Authority B Standard viewer Authority C Standard viewer Joint Review Company 4 Compilation Tool 4 Authority D Import and evaluation tool Develop one new standard acceptable for all based on and replacing the existing standards. (Note: bidirectional exchange of information is not in the scope of GHSTS Version 1)

6 Applicants Goals (2) National submissions Zonal submissions (EU) Joint Review GHSTS submissions JMPR submissions G H S T S Authorities... An open standard for exchanging different types of submissions.

7 The GHSTS project OECD Expert Group on the Electronic Exchange of Pesticide Data Mandated to investigate the possibility of harmonization in the information technology used in the pesticide regulatory process. Undertook project to develop a Global Harmonized Submission Transport Standard (GHSTS)

8 Project plan Phase 1 - Development of specification ( ) Phase 2 - Proof of concept and finalization ( ) Phase 3 - Endorsement and publication (2014) Phase 4 - Target implementation (2014- )

9 The GHSTS Set of technical specifications used to assemble electronic files for a pesticide package in a predefined manner for electronic submission.

10 Contents of an electronic submission according to the GHSTS Limited metadata (extensible Markup Language [XML]) indicating: Identity of submitting entity. Identity of receiving entity. Purpose of files contained in package. How to handle files once received. Files (e.g. MS Word, EXCEL, PDF, XML data files)

11 GHSTS Deliverables GHSTS XML schema GHSTS Specification Document (for developers of GHSTS packages and tools)

12 GHSTS Deliverables - Related components GHSTS Picklist schema definition GHSTS Table of Contents (ToC) schema definition GHSTS Viewer (not yet built)

13 Harmonisation with other electronic standards GHSTS includes elements common to electronic standards for pesticide submissions in place (CADDY ; e-index/e-prs; e-prism). GHSTS allows transport of XML-file formats for structured data, e.g. IUCLID XML files. GHSTS is harmonised with IUCLID where possible. Currently IUCLID cannot be used as a Pesticide submission transport mechanism. Reached harmonisation on a maximum of data elements. Incorporation of GHSTS requirements into future IUCLID releases, when possible.

14 Foreseen benefits of the GHSTS Single worldwide technical standard for all types of pesticide submissions. Support of submission of single dossier to multiple recipients with different requirements. Version management for submissions and documents. Delivery of structured data in the form of OECD Harmonised Templates. Transport of "raw data" and other file types that may be required in the evaluation of submissions.

15 Main Design Principles Parallel viewpoints: Human & machine readable Parallel navigation scenarios: ToC & documents Document-based organization: Files & metadata Adaptable with respect to different standard ToCs Lifecycle management: Metadata, files, content, etc. Persistent identifiers of information Information specific for regulatory authorities

16 Main Data Elements Sender and Recipient Substance / Product Dossier Sender: Legal entity submitting the dossier (incl. contact details) Recipient: Receiving Authority one sender one recipient for e.g. national submissions many senders many recipients for e.g. Joint Reviews Technical Grade Active Ingredient or formulated product Identified via name(s) and a Persistent Identifier (PID) Names may be flagged to be specific for one receiving authority (e.g. trade names) A dossier addresses a unique regulatory action (a series of events accomplished by a regulatory authority beginning with the submission of an application with data by a registrant and ending with a unique regulatory decision). Identified via a descriptive title and a Persistent Identifier (PID) Submission Data for a given regulatory action may be submitted at different points in time (e.g. additional data requests). First submission = version 01 = V01, Second submission = version 02 = V02,... ( defines the life cycle management). All data submitted for a given regulatory action define the data package (Dossier) to be evaluated by the receiving authority. Each submitted data package may contain all information or may be incremental to the preceding submission.

17 Main Data Elements (2) Document Each submission contains one to many documents to be evaluated by the receiving authority. Each document may have multiple representations, e.g. PDF, Word, XML. A document is identified by its bibliographic data, document number(s) and a Persistent Identifier (PID) (to allow for easy identification of multiple submitted content). A document refers to one or more file instances (physical content representation). Document family Logical grouping of sets of documents that are common because they have evolved from each other or have tight semantic relationships between each other, e.g. a translation. Allows easy and doubtless identification of documents related to each other. Helps to more easily identify already submitted and evaluated content (as e.g. amendments will have another PID).

18 Main Data Elements (3) Files main source supplemental XML study summaries in OECD Harmonised Template format Physical manifestation of a document s written content (or part of the content). Identified by a filename and a unique identifier (PID). Provided in defined and currently accepted file format(s). May have recipient specific flagging (e.g. Confidential Business Information). Full content representation as PDF file. Mandatory. Full content representation as office file optional Supplementary information (e.g. videos) optional Content representation as XML study summary in the OECD OECD Harmonised Templates for Reporting Chemical Test Summaries format Might be displayed in the GHSTS viewer when accompanied by style sheets (XSL files) to display an XML document. Optional

19 Main Data Elements (4) ToC-Table of Content (Guidelines) The ToC is either a flat list or a hierarchy of data points identified by node number and a node description. The GHSTS is not limited to one ToC schematic, but can handle many. Within one Dossier only one ToC schematic is allowed (OECD or OPPT or DACO, or MAFF or...) The GHSTS does not provide translations from one ToC schematic to another ToC schematic. ToC version management is available to differentiate ToC representations of the same ToC schematic. ToC-Table of Content to Document relationship Defines the relationship of ToC entry (guideline requirement) to a dossier included document. Defines in which ToC entry and dossier version a document was added (new), replaced with another member of the document family or marked as deleted. Required to organize a correct data import into authority systems. Required to display the data in different views in the GHSTS viewer, e.g. Standard Table of Contents as defined by OECD for Chemical pesticides.

20 GHSTS Viewer (not yet built) Sender and Recipient Substance / Product in-house Document and Dossier- Management System exists does not exist Dossier Submission Document Files ToC-Table of Content (Guidelines) ToC-Table of Content to Document relationship Gives easy access to all GHSTS data elements in an Internet Browser. Offers possibilities to filter data by Regulatory Authority (e.g. in joint submission scenarios). Use the cost-free GHSTS viewer for viewing and printing

21 Proposed components for the sustainability of the GHSTS ; edited by S. de Marcellus, May 2013

22 Next / Future Phase 3 (2014) Submit for endorsement at OECD. Make publically available by OECD. Phase 4 ( ) Development of implementation strategy Governance, marketing, communication, training Components of the GHSTS ecosystem Other software development, e.g. GHSTS Viewer Regulatory Authorities analysis of what is needed to adopt GHSTS

23 Thank you