Introduction

 

 

What is the Globally Harmonised Submission and Transport Standard (GHSTS)?

The Global Harmonised Submission Transport Standard (GHSTS) is a standardised set of technical specifications used to assemble electronic files for any pesticide package in a predefined manner. Microsoft Word and Excel, Adobe PDF, and XML data files are just some of the file types which can be transferred using the GHSTS according to business needs. Once the files are assembled according to the specifications, they can be transferred from one business entity to a  regulatory authority with the receiving regulatory authority able to extract the files for use in a regulatory process. The GHSTS can potentially be used to create electronic packages for other regulatory purposes as well.

Limited metadata are included in the GHSTS. Only enough information is included to identify who the submitting entity is, the purpose of the files contained within the GHSTS, and how to handle the files once received. The GHSTS itself is not intended to use the content of the files. It is not a standard for the information itself. The GHSTS is not a tool or software application.

Information Technology (IT) systems can be constructed to utilise the Standard and by doing so, would be able to easily transfer data to each other.

For more information on the GHSTS, read the Documentation and Training materials.
Benefits of the GHSTS

The main benefits of the GHSTS are:

  • The establishment of a single worldwide technical standard for all types of pesticide submissions.
  • The support of the 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 for Reporting Chemical Test Summaries.
  • The transport of "raw data" and other file types that may be required in the evaluation of submissions.
Using the GHSTS

The GHSTS standard supports applicants and regulatory authorities in the course of a dossier regulatory action for a pesticide registration by defining a standard for the representation of the individual submissions in a regulatory action. The representation is called a GHSTS package and contains all required information for a submission as well as lifecycle information to set the submission in the correct context of the dossier regulatory action.

GHSTS also supports the Joint submission and the Joint review scenario with multiple senders (registrants) and multiple receivers (regulatory authorities) for the same regulatory action.

A dossier regulatory action is a series of events accomplished by a regulatory agency beginning with the submission of an application with data by a registrant and ending with a unique regulatory decision for a given active ingredient or product.

The dossier is the set of documents prepared and continuously maintained by the applicant throughout the lifecycle of a regulatory action. A dossier has at least one submission. A submission is the compilation of documents in a structured form according to the given regulatory requirements. Multiple submissions can be submitted for each dossier; they are differentiated with version numbers.

 

Creating the package

A GHSTS submission package can be created in one of the following ways:

  • The required information and content for the submission is kept in a dossier management system and the GHSTS submission package is created by a publication component that generates the GHSTS submission package format.
  • A GHSTS standalone builder is used that is capable of creating the GHSTS submission package based on information directly supplied to this tool.

A submission package consists of:

  • The GHSTS XML main backbone - containing the metadata of the submission as well as references to the submission documents. The GHSTS XML main backbone can also contain external references, for example to a previous submission package. Part of the XML describes a structure according to a standard Table of Contents defined by authorities.
  • Submission documents.

Validating the package

After the creation of the GHSTS submission package it must be validated. The submission package cannot be validated directly by a human-reader but requires software components to be processed.

Sending the package

The validated package can then be handed over to the regulatory agency as receiver. GHSTS does not restrict the parties on how a package should be transported – for example network protocols, offline media like CD/DVD, USB and hard-drives or contained like email may be used.

Receiving the package

The receiver could work with the GHSTS package in a couple of ways:

  • A GHSTS viewer (software that allows the standalone display of a submission package in a web browser) can be used for viewing the package in a user-friendly way.
  • A GHSTS ingestion component can parse the package and ingest the data into the electronic dossier management system for review and approval.

If the submission is not the initial submission of the regulatory action then it will likely contain external references to predecessor packages.

  • During ingestion into a document management system these external references need to be resolved.
History of the development of the GHSTS

As increasing numbers of chemical agricultural pesticide submission Joint Reviews  are processed by regulatory authorities there has been an increased call for harmonisation of the review process. Currently with a number of disparate systems and methodologies in place around the world, multinational submissions are both resource intensive for the industry to assemble and awkward for the authorities to review.

The existence of multiple standards means that the applicant must duplicate their submission preparation effort in order to provide different data elements lists with matching dossier and document metadata such as title, author, guideline number and report number in a proprietary format for every electronic submission to a regulatory agency in support of an application for registration. In some cases regulators will provide a software tool to prepare electronic submissions, but data entry of metadata is usually manual work for the applicant. Manual compilation of large dossiers can take several man weeks and is an inefficient and error prone process.

For the past number of years the OECD has taken the lead by being engaged with efforts to harmonise the pesticide review process world wide.

To further the efforts of global harmonisation, the OECD Expert Group on the Electronic Exchange of Pesticide Data was tasked with investigating the possibility of harmonization in the information technology used in the pesticide regulatory process, where that harmonization might occur, and what would be required for the harmonization to take place.  As part of its investigation, the Expert Group looked specifically at the ability to harmonise the various methods used to submit information to the regulatory authorities.

The Expert Group focused its attention on the development of a common method of electronic submission – the Global Harmonised Submission Transport Standard (GHSTS).

The development of the specification, taking into account harmonisation with other existing electronic standards for pesticide submissions, took place from 2011 to 2013.

The first and current version of the Standard was published in May 2014.
Next steps in the GHSTS project

Individuals or organisations that can share lessons learned and/or offer guidance, assistance and support for any new country seeking to implement the GHSTS are being identified, as well as training materials needed to facilitate the adoption of the GHSTS.

Questions regarding the GHSTS project may be addressed to ehs.cont@oecd.org.

 

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