This is a compilation of the recent regulatory updates from emerging markets. Every week, we post an update of what's new, which you can view here.
- July 6: The Australian Digital Health Agency published its new Framework for Action, outlining a strategic work plan for implementing digital health over the next four years. The framework features the use of GS1 coding standards, supply chain solutions (master data/GDSN/GLN, and national recall solutions), patient identification, etc. The roadmap is supposed to help establish a foundation for future regulations and requirements.
- June 17: The government announced new barcoding and potential serialization requirements for products under "special pricing arrangements" and high cost medicines. Five different models are being reviewed, one of which would require secondary level serialization. The requirements will go into effect July 1, 2019 and internal consultations are starting June 20 to determine the model.
- June 3: A new circular was issued for supplying medicinal products to the Australia government for government programs. This circular mandates a July 1, 2019 deadline to include serialization.
- August 5: The NHRA published a new medicines guideline and FAQ with deadlines for master data and barcoding/serialization set for Dec. 31, 2019.
- August 5: The CNDA IT center (China National Drug Administration, which was formally the CFDA) has been tasked with developing the drug traceability process and codes. The China Association of Pharmaceutical Commerce (CAPC) is developing a recommendation paper by the end of August on the requirements for this process. GS1 Public Policy is working to support CAPC in aligning to GS1 standards wherever possible. This is all part of the previously discussed 2020 goals for China identification and traceability.
- August 5: Manufacturers and wholesalers in the country are considering implementation of a track and trace regulation. GS1 is working on a draft position paper to support those local efforts.
- April 1: A new regulatory draft was circulated for Pharmaceuticals and Medical Devices submission of product data. Neither serialization nor reporting was mentioned in the draft.
- November 11: Egypt published an update to their drug track and trace requirements, which document the data and encoding guidelines for individual packs and cases of medicines throughout the supply chain. Along with these guidelines, it was announced that MAHs/manufacturers must submit an initial report and implementation plan to include barcoding and serialization for all medicines and GTINs/GLNs for each company by the end of 2018.
- June 29: The serialization and government reporting requirements for June 2018 have been postponed as long as MAH apply a barcode and identifier to at least one pack and report it to the Ministry of Health by the end of the year. No reset timelines were published.
- April 1: The official track and trace implementation guidelines are finished and will be published this coming week (week of 4/2). Serialization and compliance reporting details will be included with a follow-up on technical guidelines for specific integration requirements to Egypt national system. No announcements will be made on deadlines, but the outcome of the upcoming April stakeholder meeting with the Ministry of Health is expected to result in the serialization deadline of June 2018 sticking and aggregation/compliance reporting being delayed until 2019.
- March 11: Industry guidance on regulations is ready for publication but a circulation date hasn't been set. The XML reporting schema will follow soon after and the June 2018 deadline still stands.
- February 25: A cross-industry stakeholder meeting was held, with some discussion of agreement to delay the June 2018 deadline for serialization and reporting to 2019 given slow progress on publishing guidelines and the start up of the government system. Recommendations may be made to start with high-priority drugs as a pilot.
- January 28: Ministry of Health is drafting serialization and reporting requirements for February publication. They are still expecting full serialization compliance by June 2018.
- April 1: Meetings continue with regulators to discuss the criteria for serialization in 2020. Both 2D DM and QR Codes are allowed today and the industry is advocating for continued allowance of 2D when the 2020 regulation goes into effect.
- February 25: It is expected that technical guidelines will be published in 2018 for the 2020/2025 serialization/track and trace requirements that are in draft form. BPOM has asked the industry for feedback on their potential timelines. Some pharmaceutical companies have been stating they will be ready for serialization using GS1 2D in early 2019.
- February 11: The use of QR codes (not 2D DataMatrix barcodes) has been officially adopted, with an initial focus on Vaccines starting in 2018 for adoption through 2020.
- September 9: JFDA has postponed the implementation of barcoding and serialization until Dec. 31, 2019.
- July 15: Government is moving forward with their plans for serialization and traceability with a target of draft regulations by the end of the year. Potential timelines: Pilot (2018-2019); voluntary coding (2020-2021); and serialization of all products (2023).
- April 8: Formal general guidelines were circulated for a future track and trace system, with an initial pilot project being slated for 2018-19 and phase in of labeling/reporting in 2020-2024.
- March 11: Government is looking at serialization and traceability of all medicines. An internal letter has been circulated in government ministries but nothing formal has been stated.
- October 28: A new government decree extended the implementation date for 2D barcoding until December 31, 2019 for imported medicines and December 31, 2022 for domestically produced medicines. Based on this decision, serialization updates are still pending.
- August 5: Ministry of Health published a statement allowing for pharmaceutical companies unable to make the Jan. 2019 deadline to follow an alternative transitional strategy using stickers.
- October 7: Malaysian Ministry of Health (MoH) published their formal regulatory requirements this past week, including a timeline for full implementation by 2023 with phased implementation to start in 2020. These requirements include serialization and full track and trace to a central government repository using EPCIS. The overall transaction event model is based on Turkey.
- September 9: Draft regulatory requirements were published by the Ministry of Health for serialization and track and trace reporting to a government system. These regulations will be phased in over the next two years, with firm deadlines still being worked out.
- September 2: The Malyasian National Regulatory Conference (NRC) 2018 in early October will discuss the upcoming serialization and reporting requirements on day 3 of the conference.
- April 1: Draft regulation is expected to be published 6/13 but no data has been released thus far on scale/scope.
- September 16: The Gulf Health Council has published new barcoding requirements for Gulf Cooperation Council (GCC) countries. Deadlines for these requirements have not yet been set.
- June 3: A new government circular on serialization regulations with standards GS1 identifiers will be issued March 1, 2019, which will cover all registered Rx, health products, and registered medical devices.
- October 7: PharmaBureau and DRAP met on September 26 to continue discussing the alignment of regulatory requirements and identification needs with the global framework for serialization and traceability.
- September 23: The Drug Regulatory Authority of Pakistan (DRAP) published a compilation of public comments for review prior to a meeting scheduled for September 28 with a broad group of industry stakeholders. This meeting will discuss the path forward for national serialization regulations and implementation requirements.
- June 10: Government reaffirmed that the AI240 may not be removed from the serialization requirements for the fifth data element, although individual companies may apply for exemptions.
- April 29: An update was published to coding regulations with enhancements to require the barcode not only on the outside box but also on the wrappers/containers of the medicine. This may be a push to introduce Primary level serialization on the medicines in Pakistan.
- March 18: Pakistan Court of Justice determined during a recent hearing that DRAP, Pharma Bureau, and industry will have three months to agree to an implementation timeline for barcoding and serialization, upon which the timeline will be formalized and published and the industry will be required to meet such a timeline.
- February 11: Punjab province regulators announced the removal of Application Identification (AI) coding in barcode to better align with GS1 standards, but the existing barcoding/serialization regulations for the country at large still include them.
- January 14: DRAP published minutes of a Dec. 14 2017 meeting discussing the current state of barcoding of medicines. With only partial compliance by the industry thus far and a new recommended product coding identification scheme, DRAP recommended to the government to extend the deadline for barcoding.
- April 29: Government legislation was published that reaffirmed the alignment of scope under EU FMD and formalized the content of the product identifier.
- August 5: GS1 is working with local authorities to help clarify the use of GTIN-13 with leading 0 vs. GTIN-14.
- November 4: New deadlines of July 2019 have been published for aggregation and compliance reporting.
- October 28: Compliance implementation guidelines were updated and published this past week. These updates did not include a listing of dates for compliance.
- August 5: The comment period on the draft Integration Guide for compliance has now closed. An updated Guide is expected by the end of September.
- February 11: The reporting of GLN codes is required by February 28 for each factory and warehouse serving the country.
- September 2: Regulators have noted that the final regulatory requirements are expected to be published by the end of September.
- January 14: Department of Health is reviewing comments submitted in 2017 on draft serialization requirements but no final timeline was stated for when the review will be completed.
- March 11: Government added 30 more products to a list of products targeted for the upcoming track and trace regulations.
- August 5: The Ministry of Health circulated a list of 15 questions for public feedback regarding data requirements and data management for serialization and traceability. The current draft law "On Medicines" only refers to lot-level traceability and the MoH is also working on potentially cross-tying traceability with medicine reimbursement.
- September 23: A draft government circular was published for drug registration, quality documentation, and barcoding using standard barcodes or QR codes. This circular included a few technical details, but did not include final deadlines.
- September 9: A government circular was published that lists the draft requirements to put a QR Code on the outer box of medicines.