Upcoming Pharma Regulations 2024

[Blog] Pharma Regulations: What will the Pharma industry face in 2024?

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Discover the upcoming track and trace deadlines and requirements ahead of the Pharma industry in 2024

 

As an industry with a crucial impact on consumer safety, the Pharma industry faces new regulatory regulations and requirements almost continuously. Regarding track and trace of medicines, in 2024 Pharmaceuticals are going to meet traceability deadlines for the USA, Jordan, Kuwait, Kyrgyzstan, Kazakhstan, Ecuador, and Ethiopia. Moreover, the pharma supply chain has to be prepared to face regulatory requirements for some other countries such as Azerbaijan, Nigeria and Rwanda. Let`s not waste time and dive into the topic >>

 

 

 

 

 

Track & Trace Deadlines in Q1 and Q2

 

In the first two quarters of 2024, Pharmaceuticals will meet the deadline in the following countries:

 

  • Jordan – JFDA released a new document with instructions for applying DataMatrix and the requirements for serialization and DataMatrix for pharmaceutical products in Jordan. The new deadline to comply with the requirements is 1 January 2024.

 

  • Kuwait – the deadline for drug serialization and tracking has been set for January 2024. All pharmaceutical products to be sold in Kuwait, imported, or locally manufactured, must have a GS1 DataMatrix with 4 data elements. Thus, all local requirements must be implemented by the end of 2023.

 

  • Ethiopia – the start of serialization for listed pharmaceuticals is set for 19 February 2024.

 

  • Kyrgyzstan – the deadline for Implementation of traceability for medicines included in the traceability system, List No. 3 and not included in Lists No. 1 and No. 2, is 1 March 2024. As for the Implementation of traceability for all medicinal products in circulation in the territory of the Kyrgyz Republic, the deadline is set for 30 June 2024.

 

 

 

 

Track & Trace Deadlines in Q3 and Q4

 

The second two quarters will also bring some deadlines for pharma supply chain participants in the following countries:

 

  • USA – On August 25, 2023, the U.S. Food and Drug Administration (FDA) announced that it was delayed by one-year enforcement of key requirements under the Drug Supply Chain Security Act (DSCSA). This “extended stabilization period” moves the enforcement date from November 27, 2023 to November 27, 2024. The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. By November 27, 2024, all stakeholders must have interoperable systems in place to share and verify package-level product identifier data electronically. The new compliance deadline of 27 November 2024 will help achieve DSCSA’s prescription drug product traceability and security goals while minimizing supply disruptions and avoiding interruptions to patient care.

 

  • Kazakhstan – the Kazakh regulatory deadlines are divided into stages, as the 1st Stage, Mandatory labelling of 100 % of medicines, must be finished by 1 July 2024. The 2nd Stage, Serialization of drugs purchased by a single distributor (for government procurement), is planned to start from 1 July 2024.

 

  • Ecuador – the establishment of a track and trace mechanism started in 2019, according to the latest update, all supply chain actors shall comply with batch traceability for listed pharmaceutical secondary packages and their higher packaging levels from 19 August 2024.

 

 

 

 

Other upcoming track and trace regulations

 

Azerbaijan is among the countries that announced the launch of a Traceability system in 2024 without specifying the concrete serialization requirements. The next one on the list is Rwanda – the country notified that the master data for all authorized pharmaceutical products, their packaging levels, and their associated locations and legal entities and pharmaceutical products shall be shared with the Authority in 2024. Lastly, in Nigeria, the NAFDAC developed a 5-Year Traceability Implementation plan in line with the national strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of Substandard and Falsified Medicines and Medical Devices. From this strategy document, it is expected that traceability will become fully operational in the Nigerian Pharmaceutical Supply Chain by the end of the year 2024.

 

 

 

 

2024 is turning into a dynamic year from the very beginning. The requirements are diverse and could look challenging in the first place. If you need more information regarding the regulatory compliance and implementation of the Track & Trace system, schedule a meeting with our experts.