Supply Chain Integrity

 

Recommendations on common technical denominators for track and trace systems to allow for interoperability

August 6, 2021

The International Coalition of Medicines Regulatory Authorities (ICMRA) published recommendations to facilitate the use of track and trace systems at global level. The paper identifies common technical denominators that allow different systems to exchange and use the available information on medicines and their supply chains in order to protect public health.

In this paper, international regulators emphasise that the interoperability of track and trace systems helps to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities. A common understanding of these potential benefits of interoperability is fundamental to promoting global planning and implementation of interoperable systems for medicines.

The ICMRA paper was open for public consultation from November 2020 to February 2021. The extensive and helpful feedback was carefully analysed and reviewed in order to refine and finalise the recommendations on common technical denominators for track and trace systems. More details on the comments received and the ICMRA analysis of these comments is available in a separate document.

November 27, 2020

The International Coalition of Medicines Regulatory Authorities (ICMRA) has developed a draft paper with recommendations on common technical denominators for track and trace (T&T) systems. It aims to facilitate the implementation of interoperable systems for medicines around the world.

In this paper, regulators emphasize that interoperability of T&T systems would help to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities.

The draft recommendations are available for public consultation until 28 February 2021:

Stakeholders can send their comments on the document via an online form to icmratrackandtrace@ema.europa.eu.

The draft recommendations were developed in consultation with the World Health Organisation (WHO), representatives from international medicines regulatory authorities and experts from the private sector.

ICMRA intends to publish the final document in 2021 after considering the responses to the public consultation.

 

Call for Expression of Interest in a Joint ICMRA-Industry Working Group

October 26, 2018

Production and distribution of medicines are globalized and rapid exchange of information among regulatory authorities is integral to the protection of the supply chain integrity and patient safety. Track & Trace (T&T) systems can contribute to rapid exchange of information. However, so far these systems have been designed and implemented with a local or regional focus, without consideration as to their interoperability with other such systems.

Building on work already done by the World Health Organization’s (WHO) Substandard and Falsified (SF) Medical Products initiative (previously Member States Mechanism), ICMRA collected information on existing and planned T&T systems for medicines around the world. Based on this information it developed recommendations on how existing and planned T&T systems could be better aligned globally, to allow for interoperability. These recommendations have been published on the ICMRA website (see below).

As a next step in this project, ICMRA is now establishing a working group to facilitate implementation of the principles in the recommendations document. Because this work needs expertise from both regulators and industry, ICMRA has decided to launch a call for expression of interest to identify potential experts from the industry with appropriate knowledge in T&T systems. ICMRA is seeking to nominate a maximum of ten industry experts, representing as broad a geographical spread as possible.

The participants in the working group are expected to work towards the following deliverables:

  • More detailed guidance on common technical features to enable interoperability of T&T systems
  • Capacity building tools for jurisdictions wishing to implement T&T systems
  • Solutions/tools for systems to become interoperable, applicable to both new systems and already existing ones.
  • Analysis of technical aspects related to interactions between alert systems and T&T systems
  • Identification of solutions to overcome barriers to exchange of information between different T&T systems (including e.g. data ownerships and confidentiality issues)

The expected duration of the project is one year. This may be extended, if necessary.  The project will be led by one of the regulatory agencies participating in ICMRA, who will report regularly to the ICMRA Executive Committee and plenary.

Any outcome of the project will be adopted by the ICMRA plenary. All outcomes will be made public and published on the ICMRA website.

Those interested in joining are kindly asked to submit an expression of interest as outlined in the following document:

NOTE: The deadline for submission of expressions of interest was January 15th, 2019.

ICMRA Supply Chain Integrity - Call for expression of interest
 

 

Track and Trace Recommendations Paper

December 20, 2017

Supply Chain Integrity has been an ICMRA strategic priority since November 2015. Given the importance of Track and Trace (T&T) systems in ensuring the integrity of the medicines supply chains, ICMRA agreed that this project, at least in its initial phase, would focus on T&T systems.

T&T systems have been so far designed and implemented with a local or regional focus, and no consideration has been given to their interoperability. As production and distribution of medicines are nowadays often globalised however, the rapid exchange of regulatory information among regulatory authorities is integral to the protection of the supply chain integrity and to the protection of patient safety. T&T systems could enable such rapid exchange of information among regulatory authorities along the supply chain.

ICMRA, building on work already done by the WHO SF Member States Mechanism, collected information on existing and planned T&T systems for medicines around the world and used this information to develop recommendations on how existing and planned T&T systems should be better aligned globally, in order to allow for their interoperability. This document discusses various aspects such as the prospective advantages for public health which would arise from interoperability of T&T systems for medicines and what the challenges are to reach such interoperability. It also recommends some common technical features T&T systems should have in order to enable their interoperability and proposes next steps ICMRA might take in order to implement these recommendations. The document has been endorsed as a formal ICMRA document, and is provided below.

ICMRA T&T Recommendations.pdf