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.
- January 10: GS1 Africa summarized activity throughout the continent, which consisted primarily of awareness workshops on GS1 standards and traceability in 2020 and continuing into 2021. Countries noted were Kenya, Botswana, Namibia, Senegal, Benin, Burkina Faso, Togo, Ghana, Rwanda, and Ethiopia. The bulk of these efforts has been driven alongside USAID.
- November 24: The South African Development Community (SADC) circulated draft guidelines for product labeling and barcoding with QR codes. The guidelines, which are early stage, are being reviewed by the 16 countries that participate in the SADC and may influence serialization and traceability requirements in those countries in the future.
- July 26: Australia’s new medicine coding and identification requirements are being circulated for public consultation. These requirements would formalize barcoding and serialization for all medicines. Today, barcoding is required on many medicines, and serialization for some blood-related products.
- July 21: The Australian government's Therapeutic Goods Association (TGA) has published updates to their guidance documents on TGA 91/92 about the identity of medicines. One of the key updates provides clarification on product coding.
- 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.
- December 13: The National Health Regualatory Authority (NHRA) released v1.2 of its Technical Onboarding Guideline.
- November 15: The NHRA-MVC issued Circular No. (46) 2020 that moved the aggregation requirement to May 1, 2022. An update to the technical guidelines, now v1.1, has also been issued.
- November 8: The National Health Regulatory Authority (NHRA) issued its initial draft of the Technical Onboarding guidelines v1.0 for connection to the Traceability Hub.
- September 27: Bahrain’s government published a circular documenting the next steps for traceability reporting. The steps must be implemented by October 1, 2021.
- January 20: Version 1.1 of the Medicines Barcoding and Serialization Guidelines document was published. The changes to this version included adjustments to the mandatory and optional fields.
- August 5: The NHRA published a new medicines guideline and FAQ with deadlines for master data and barcoding/serialization set for Dec. 31, 2019.
- October 25: A new draft law has been circulated. The main changes relate to the National Product Number and remove the obligation for it to be printed on the packs as part of the verification code. Instead, the National Product Number will be generated by the Bulgarian Drug Authority (BDA), used in the products registries, and digitally linked to the product numbers already printed on the packs.
- 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.
- December 13: The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) published the list of Phase 1 products for traceability in the public health sector by May 26, 2021. Traceability for these products will extend to private channels such as community pharmacies by November 26, 2021.
- December 6: The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) has published their traceability regulation in the country’s Official Gazette, establishing a first-phase deadline for May 26, 2021. Products in the various phases have not been announced. The central system and technical guidelines are scheduled to be published by March 26, 2021.
- November 29: The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) published an updated guideline that indicates the first-phase deadline as May 2021 for certain medicines as determined by the health authority. It also states that ARCSA will be acquiring a central reporting system by mid-March 2021 and that technical guidelines will be available then.
- November 15: The current draft regulations indicate a phase-in by product and dispensation channel beginning 6 months after the final regulation is published, with deadlines ranging from May 2021 to November 2022 if the final regulation is published at end of November 2020 as communicated. Traceability system guidelines are stated to be published within 60 days of the Resolution publication date, so are expected by January 2021.
- November 8: The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) issued an updated draft regulation document from the August 2020 version. Technical guidelines still have not been issued.
- September 13: Ecuador's government published new regulations mandating that serialization and traceability reporting be implemented in six months.
- December 13: The Ethiopian Food and Drug Administration (EFDA) published a list of Master Data Attributes based on GS1 standards. The deadline for submission is still under discussion.
Eurasian Economic Union (EAEU)
- August 4: The Eurasian Economic Commission met to discuss the adoption of uniform serialization and cryptographic requirements across the five-member countries of the Eurasian Economic Union (EAEU) based on those being adopted by Russia. Future discussions are expected to address members’ concerns about implementation timelines and complexity as the roadmap is finalized.
- December 13: The Indonesian food and drug authority, Badan Pengawas Obat dan Makanan (BPOM) held an industry consultation on December 10 to discuss a new draft version of the regulation. This version extends the traceability deadline from 2 years to 3 years from electronic license renewal. Aggregation is required, and there are minor changes in product exemptions in primary packaging.
- January 20: An updated background summary was circulated on the upcoming barcoding, serialization, and reporting requirements that will be phased in from 2020 to 2025.
- 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.
- January 20: The Ministry of Health circulated an outline of discussions for a proposed new electronic Product Information Leaflet, which will include a QR code.
- September 9: JFDA has postponed the implementation of barcoding and serialization until Dec. 31, 2019.
- March 10: The Kazakhstan Ministry of Health (MOH) continues work on their pilot program for pharmaceutical track and trace regulations. The MOH plans to focus on GS1 standards, but it has yet to be determined if they will align more closely with the European Union/Turkey approach or the Russia approach to GS1 standards.
- 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.
- November 29: The Lebanese Ministry of Health issued an update to its barcoding guideline and the use of the MediTrack system for uploading product information. No deadline has been communicated.
- 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.
- August 30: Malaysia’s government issued an update on the country’s serialization and traceability plans, reinforcing its intention to move forward with a 2023 deadline for full implementation of regulations.
- 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.
- November 22: The government of the UAE circulated a formal announcement for their forthcoming track-and-trace system which was mentioned in their 2019 future vision document. No specifics on requirements or deadlines were included.
- September 13: The Abu Dhabi emirate published a circular announcing new coding and serialization requirements for 2021 as well as information on submitting product master data to the United Arab Emirates portal.
- 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.
- December 16: An article was published in CoinReport, which mentioned that the government will be launching their first blockchain track and trace pilot project designed to remove counterfeit drugs in the country.
- December 16: A new government circular clarified that their barcoding/serialization requirements only cover pharmaceutical products while herbal and other medical products and devices are not in scope for the regulation.
- 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.
- March 31: The government circulated a draft of Statutory Regulatory Order (SRO) 470 among internal ministries to finalize the adjusted serialization timelines that were first stated in January.
- December 9: An agreement between regulatory and the Supreme Court has laid out new timelines and requirements for coding, serialization, and track and trace implementation.
- 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.
- An eHealth circular was published with initial thoughts on placing a QR code on pharmaceutical packages to enable identification and product information access. The industry is also considering the use of GS1 2D barcodes with DigitalLink capabilities.
- November 25: The government published draft guidance to gain feedback on electronic labeling of therapeutic products. Deadlines have not yet been outlined for the labeling requirements.
- March 10: The government is beginning to look into digital track and trace requirements and other global approaches as they create their pharmaceutical regulations.
- 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.
- July 21: The SAFEMed project to improve the safety of medicines in the supply chain through identity and traceability was published by the United States Agency for International Development (USAID). This project is distinct from the Ministry of Health’s similar project.
- March 17: The Ukraine Ministry of Health (MOH) published a draft regulatory circular outlining the implementation of a serialization and traceability system from 2019 to 2024. The first step is the launch of a pilot project in Q4 of 2019 that will last until the end of 2020, which includes the development and creation of the main components of the system—labeling, software, changes in legislation, and monitoring. Mandatory labeling on the list of drugs established by the MoH will be introduced in 2021, and that list will be expanded in 2024.
- 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.