pharma track and trace regulations 2023

[Blog] Pharma Regulations: What will the Pharma industry face in 2023?


This year pharma industry will face new regulatory requirements for Kyrgyzstan, Kazakhstan, Saudi Arabia, UAE, USA and Australia.


Regulatory Compliance is a permanent hot topic for all supply chain participants.2023 is bringing new challenges regarding the track and trace requirements. Here are the essentials of the upcoming mandatory serialization and aggregation regulations ->

The government of Kyrgyz Republic has taken measures against drug counterfeiting, including the medicines in the binding product list for labelling. The traceability system for medicines and medical devices identification of the Kyrgyz Republic will be live in 2023. The deadline for serialization and aggregation requirements is Q3 2023. However, voluntary serialization implementation waves are planned for 1) January 2023; 2) April 2023; 3) August 2023. Moreover, a 2-year transition period is laid down, meaning that serialized products with any country labelling will be allowed for 2 years.

Pharma Track and Trace requirements for Kazakhstan has been a topic for a couple of months among the supply chain as in 2023 the serialization will become 100% mandatory. Regarding the aggregation, it is carried out in the presence of several levels of nesting: 1) aggregation of the first level – the combination of primary and (or) secondary packages into a transport packaging; 2) aggregation of the second level – combining transport packages into another transport package of a higher level of nesting.

As one of the most dynamically developing countries in the MENA region, Saudi Arabia – is also in the final stage of traceability system implementation. The Saudi Arabia Healthcare Transformation Project has been ongoing since 2018, setting three goals to improve access, quality, and value. Moreover, unlike in Europe, a complete track-and-trace system includes the introduction of aggregation processes.

Having innovation and growth in mind, it is essential to note that the UAE`s traceability solution – Tatmeen is also going into force this year. All manufacturing sites licensed to dispense medicines in the UAE must be registered with a GS1 global location number (“GLN”). Pharmaceutical products already within the UAE before 13 December 2021 may continue to be sold without complying with the decree until the quantities in the country run out at the various trading points.

In December, FDA held a meeting primarily focused on the Implementation and Readiness of DSCSA 2023. The second phase of requirements will go into effect in November this year allowing the track and trace process of medicines at the package level.  The main goals are in direction:

  • Product Tracing Enhancement – including the exchange of transaction information (TI) and transaction statement (TS); a gathering of relevant product tracing information in response to requests; and serialized TI
  • Verification Enhancement at the package level and salable returns

The FDA has already conducted pilot activities and meetings with pharmaceutical stakeholders to develop precise guidelines and establish the technical utility until 27 November 2023. We remind you that the DSCSA requirements cover four crucial pillars – product identification (serialization), product tracing, verification and ATPs.

Last but not least, until January 2023 the serialization and use of data matrix are optional for manufacturers and sponsors supplying medicines in Australia. (TGO) No.91 and TGO No.92 documented the requirements for Australia that are consistent with the National Medicines Policy which aims to meet medication and related service needs so that both optimal health outcomes and economic objectives are achieved. The four central objects are:
1) timely access to the medicines that Australians need, at a cost that individuals and the community can afford;

2)medicines meeting appropriate standards of quality, safety and efficacy;

3) quality use of medicines;

4)maintaining a responsible and viable medicines industry.

If you need more information regarding the regulatory compliance and implementation of Track & Trace system, schedule a meeting with our experts >>