Action Point 3 - Strategy to facilitate information sharing

Last update: 04/07/2024

Background

The first objective of SEARN is dedicated to information sharing, and especially to ‘create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between NRAs in the region’. Information sharing was also the most common and the main demand from the working groups during their meetings in January 2022 and from the Steering group in its March 2022 meeting.

However, the Heads of NRAs and their representatives considered during the Assembly of the Members of SEARN in June 2022 that the level of information shared was insufficient and requested that tangible progress are achieved for this key objective.

To address this need, the Assembly created in 2022 a dedicated action point (AP3) in the SEARN workplan, led by Working Group 4 (WG4) Information Sharing.

General objective

To facilitate information Sharing

Framework to facilitate information sharing

SEARN Terms of Reference

The SEARN terms of reverence define information sharing as the first objective of the Network, and specifically to ‘Create an enabling environment to enhance communication and information sharing on regulatory policies, guidelines, standards, procedures, outputs and regulated products and entities between NRAs in the region’.

Declaration from the Members of SEARN to facilitate information sharing

In order to renew the political commitment to share information between the NRAs and to lay the basis for a political framework to do so, a declaration from the Members of SEARN was adopted by the Assembly in July 2023:

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Declaration from the Members of SEARN to facilitate information sharing

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Guidelines to SEARN members on Information Sharing

The following guidelines were adopted by the Assembly during its meeting on 27 July 2023 and updated in February 2024:

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Guidelines to SEARN members on Information Sharing v2

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Customizable Template for Confidential Disclosure Agreement

The following Customizable Template for Confidential Disclosure Agreement was developed to facilitate bilateral agreement between SEARN members for sharing confidential/sensitive information:

Customizable Template for Confidential Disclosure Agreement

Survey on barriers to information sharing

A survey was conducted in 2024 to further identify barriers to sharing confidential information. The survey explored whether currently Members could share certain information, and what was the barrier if not.

Highlights

  • The survey highlighted that there are little obstacles remaining for sharing urgent information between SEARN Members, and all responding SEARN Members indicated they can currently share such information, which is a significant progress.
  • However, the situation is more mixed for sharing internal SOPs and templates, unredacted PV case narratives, or unredacted market control incident reports.
  • On the other hand, Members cannot at the moment share between themselves unredacted marketing authorisation assessment reports or quality dossier, unredacted GMP inspection reports, or laboratory Certificates of Analysis.
  • In most Members, beyond agreement from the Heads and changes in SOP/guidelines, some MoU, Confidential Disclosure Agreement (CDA) or agreement from other authorities would be required.
  • Beyond, some changes in the regulation and/or law are required in some SEARN Members to be able to share such information without specific/ad hoc agreement from the marketing authorization holder.

Sharing of routine information required to develop reliance

Requirements of information sharing to develop reliance

The discussions under the Strategy to facilitate reliance highlighted that effective reliance would require sharing confidential information, including e.g. assessment reports, elements from the marketing authorization dossier, GMP inspection reports etc. without requiring the ad hoc authorisation from the Marketing authorisation holders.

Information from the Global Benchmarking Tool and the WHO-Listed Authority assessments

In line with the 2023 Declaration from the Members of SEARN to facilitate information sharing and the SEARN Guidelines to SEARN members on Information Sharing, a dedicated section accessible only to SEARN NRAs was created on the SEARN internal platform to share information in the region about:

  • the type of benchmarking,
  • the overall maturity level,
  • the overall maturity level for each function.

Sharing ad hoc urgent information between SEARN Members

Form for sharing ad hoc urgent information between Members

In line with the Guidelines to SEARN members on Information Sharing, a form for sharing urgent information between SEARN members was created and approved, and has been made available in a dedicated folder on the SEARN internal platform. It was agreed that this template may start being implemented from 1st January 2024.

In addition, some guidelines were developed to assist SEARN Members in assessing the risk, when filing the form.

Next steps

The Assembly recommended to the Heads of NRA that each SEARN Member prepares a strategy with target timelines to address obstacles to information sharing for the identified key information by the end of 2024, and requested SEARN to follow up on the progress twice a year, including at the time of the meeting of the SEARN Assembly.

In addition, the following actions were recommended:

  1. To set up a system for monitoring the progress on the national strategies to facilitate information sharing.
  2. Develop an MoU on sharing information with the target of signing it during the next meeting of the Assembly
  3. Address any challenge arising from the implementation of the outputs of action point 3