Network

Back

Worldwide Regulatory Updates

 

United States/DSCSA

  • October 10: The FDA held a public meeting on October 5 to present its EDDS (Enhanced Drug Distribution Security) Draft Guidance. The meeting was aimed at all supply chain stakeholders and presented a comprehensive overview of 2023 requirements. Webinar slides are available on the Small Business and Industry Assistance (SBIA) Education Events website.
  • October 10: The FDA still has not published their summary report of the FDA Pilot Project nor the collection of individual project reports, including from TraceLink.

 

European Union/FMD

  • October 10: No further news at this time on the European Commission’s proposal to restrict data upload to the EMVS only through hardware/software infrastructure physically located in the European Economic Area and Northern Ireland.
  • October 10: EMVO announced its next FMD Implementation Workshop for November 18.
  • October 10: The Czech NMVO (NOOL) updated its “Important Information / Q&A” aimed at end-users.
  • October 10: The Danish NMVO (DMVO) continues to receive requests on reactivating packs that have been decommissioned, and reminds users that there is a 10-day window for doing so. Reactivation must be done from the same location and some statuses, such as “exported”, cannot be reversed.
  • October 10: The Latvian NMVO (LZVO) announced the pilot phase of the Alert Management System (AMS) Hub, effectively launching the pilot in the production environment as of October 4.
  • October 10: The Maltese NMVO (MaMVO) will hold an explanatory session of NMVS Release 9 on October 14. The event is aimed at end-users and requires registration.
  • October 10: The Icelandic NMVO (ICEMVO) published its findings on reducing alert rates, with “double decommissioning” the primary culprit, and announced plans to connect to the Alert Management System (AMS) Hub in 2022.

 

Africa

  • October 10: The Zambia Medicines Regulatory Authority (ZAMRA) has launched a public consultation on proposed requirements for Master Data and barcoding and serialization of medicines.

 

Bahrain

  • October 10: TraceLink is seeking clarification from the National Health Regulatory Authority (NHRA) on reporting requirements for in-country shipments from agents/distributors and whether an Invoicing Company can delegate its reporting responsibilities to another entity such as a distributor.

 

Brazil

  • October 10: ANVISA has made the SNCM Portal available for submitting Serialization Plans as of October 6. According to the Normative Instruction, stakeholders have 30 calendar days to submit their plan.
  • October 10: Industry is seeking clarification on question 3.4.3 of ANVISA’s “Questions and Answers on SNCM Implementation.” The question deals with the reporting and timing of the “Activation Event” of finished goods based on whether they are produced domestically or imported.

 

China

  • October 10: The National Medical Products Administration (NMPA) has opened a consultation on the Drug Recalls process until October 29, 2021.

 

Ecuador

  • October 10: No updates from the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) on the status of the launch of a 5-week pilot to test traceability readiness for medical devices. The launch was scheduled for September 27.

 

Egypt

  • October 10: GS1 Egypt has not yet provided comments and suggestions to the Egyptian Drug Authority (EDA) on version 3 of the implementation guidelines.

 

Indonesia

  • October 10: The National Agency of Drug and Food Control (BPOM) recently updated its portal with version 3.0.1 of its APIs and version 2.0 of its Track and Trace Anti-Counterfeit (TTAC) website manuals.

 

Kazakhstan

  • October 10: The latest timelines from the Kazakh Ministry of Health represent a slight shift from their previous update:
    • July 1, 2022 - labeling for 93 medications; list indicates marketing authorization number and manufacturer
    • October 1, 2022 - expansion of list to cover 20% of medications on market
    • January 1, 2023 - 60% of medications to be covered
    • April 1, 2023 - 80% of medications to be covered
    • July 1, 2023 - 100% coverage
  • October 10: Discussions are ongoing with Kazakhtelecom to accept e-signatures from entities outside Kazakhstan.

 

Lebanon

  • October 10: Deadlines for full implementation are not yet published, but a traceability committee is being organized by the MoPH (Ministry of Public Health).

 

Russia

  • October 10: The pilot for marking Nutritional Supplements is gaining momentum, with 132 participants, including 48 manufacturers.
  • October 10: The industry is seeking clarity on whether a recent draft decree to Decree 1955 / 2019 to give weekly access to manufacturers and importers of downstream traceability data for their products is applicable to medicines.

 

UAE

  • October 10: The December 13, 2022 deadline for aggregation, serial number reporting, and obtaining GLNs has been confirmed by the Ministry of Health and Prevention (MoHAP). December 2021 deadlines are in place for Master Data reporting and barcoding, but no technical details on the Tatmeen system have been published.

 

TraceLink is the world’s largest digital supply network for the pharmaceutical industry supply chain. It enables firms in the healthcare sector to achieve greater transparency, agility, and resiliency in pharma supply chains and enhance pharmaceutical supply chain security through real-time information and insights sharing. Providing firms in the pharma value chain with the tools and advanced capabilities they need to improve pharmaceutical supply chain management, TraceLink’s technology is powering the digital transformation of the global medical supply chain and accelerating pharmaceutical supply chain optimization. TraceLink helps pharmaceutical supply partners better manage and build flexibility and resilience into medical supply chains by providing them with innovative pharmaceutical supply chain solutions that help promote and foster communication, collaboration, and enduring strategic partnerships.