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Korea's Ministry of Health and Welfare has announced new phased pharmaceutical serialization deadlines. In a publication on August 7, 2014, the MOHW adjusted the serialization dates to allow two phases starting January 1, 2015.

Pharmaceuticals must be serialized according to the following schedule:

  • January 1, 2015:  30% of products (by sales), plus all psychotropics, biologics and drugs that are flammable or explosive.
  • January 1, 2016:  All pharmaceutical products.
  • Companies should submit an implementation plan describing the products to be committed for phase 1 by October 2014

Beginning in January 2016, serialized product supply reporting also begins.

The remaining attributes of the Korea serialization regulations (barcoding specification, optional aggregation, etc.) remained unchanged. Korea is also planning to undertake a series of supply chain traceability pilots starting in 2015 to help inform the development of an end-to-end traceability system for Korea.

Here is the link to the original announcement (in Korean).

Here is a detailed press release describing in more detail the requirements (in English).

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HDMA, the Health Distribution Management Association, has released an update to the implementation guideline for the EDI 856 Advanced Ship Notice to support DSCSA 2015 product tracing compliance.

The "HDMA ASN" as it is known was first published in May 2014. This new update provides additional support for identifying transfer of ownership (e.g. ship to, ship from, buyer and seller information). The update also includes support for the Direct Purchase Statement required when TH, TI and TS are provided to a Dispenser from a Wholesale Distributor under the Direct Purchase DSCSA scenario. 

HDMA ASN is one of several interoperable data exchange approaches supported by the TraceLink Life Sciences Cloud for end-to-end DSCSA compliance with all trading partners. One connection to the Life Sciences Cloud and a company can exchange DSCSA TH, TI, TS with all suppliers and trading partners, regardless of partner technical capabilities.

The HDMA ASN data exchange guideline is available as a complimentary download from the HDMA Marketplace.

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India's Directorate Generate of Foreign Trade today officially announced a deferment of the primary level pharmaceutical serialization requirement which was originally slated to go into force on July 1, 2014.

Barcoding and serialization of other levels of packaging have already come into force, including Tertiary Level (October 1, 2011) and Secondary Level (January 1, 2013). The primary level serialization requirement would have added significant new complexity for pharmaceutical packaging.

Mono cartons which were earlier to be treated as part of primary level packaging are now to be treated as secondary level packaging instead. The self certification process which went into effect on May 15, 2014 stayed unchanged in the latest notice.

Yet to be announced but rumored to be in development is the design of the India track and trace reporting system for exported products.

You can read the official India DGFT notice.

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The FDA released its suspect product guidance today to help the industry in its implementation of the Drug Supply Chain Security Act. The guidance entitled "Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification" provides information for identifying suspect products and managing termination of illegitimate product investigations.

NOTE: This guidance does not address data exchange questions with respect to requests for information and verification queries from government officials or trading partners as required by DSCSA verification regulations. Register for this short webinar summarizing the guidance and 2015 DSCSA verification.

DSCSA Suspect Product Guidance has four goals:

  • ID specific scenarios that could significantly increase the risk of a suspect product
  • Provide recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable
  • Process by which trading partners should notify the FDA of illegitimate product
  • How they must terminate the notifications in consultation with the FDA

Suspect product covers several scenarios in DSCSA including potentially counterfeit, diverted, stolen, adulterated, subject of a fraudulent transaction or otherwise unfit for distribution.

The FDA makes it clear that this guidance doesn't address all DSCSA provisions related to suspect and illegitimate guidance. Furthermore, this document is meant to be viewed as a set of recommendations, not new regulatory rules, unless outlined as required by law. Most of the commentary is focused on laying out a set of standard operating procedures for these processes

Guidance summary:

  • Specific suspect product scenarios
  • Recommendations for identifying suspect product
  • Notification of illegitimate product
  • Termination of illegitimate product notification with FDA

The biggest new area relates to the FDA Form 3911 (Attachment A) which must be completed and submitted to the FDA when initiating an illegitimate product notification or when requesting a consultation with the FDA for terminating an illegitimate product notification.

Here is the Drug Notification page on the FDA website with more details on notification submission.

UPDATE: The FDA CDER Small Business and Industry Assistance (SBIA) department is holding a webinar on July 1, 2014 to discuss the new guidance. Here is the information page for the: CDER SBIA Webinar. Live Q/A will be taken during the event.

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The FDA has released their summary readout of the May 8-9 public workshop on interoperable data exchange for the Drug Supply Chain Security Act. Review the summary. <Note: Summary is a PDF that opens in a new window>

The public workshop brought together over 140 pharmaceutical industry stakeholders and the FDA to discuss methods to exchange required compliance documentation for DSCSA compliance including the Transaction History, Transaction Information and Transaction Statement.

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The FDA held a two day public workshop to discus interoperable data exchange for compliance with the upcoming Drug Supply Chain Security Act (DSCSA - DQSA Title II). This workshop brought together the FDA, industry stakeholders, standards organizations and solution providers like TraceLink to work together in developing options and solutions for companies to share DSCSA-required compliance information.

Presentations for the public workshop are now available here.

A recorded webinar on the FDA discussions and takeaways from the workshop are available here.

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The FDA is holding a two day public workshop to discus interoperable data exchange for compliance with the upcoming Drug Supply Chain Security Act (DSCSA - DQSA Title II). This workshop brings together the FDA, industry stakeholders, standards organizations and solution providers like TraceLink to work together in developing options and solutions for companies to share DSCSA-required compliance information.

TraceLink held a FDA Workshop readout webinar on May 13. Listen to the streaming replay to get a summary of the discussions and any key takeaways from the FDA event.

Workshop Details:

  • Topic: Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format
  • FDA's White Oak Campus, Silver Spring MD
  • May 8-9, from 9am to 5pm

Topics:

  • Transaction History, Information and Statement structure and format
  • Data exchange options (HDMA ASN, GS1 EPCIS, secure web portal, etc.)
  • Verification, Request for Information and other suspect product investigation queries
  • Data exchange methods between industry stakeholders and with the FDA

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The FDA has posted their current activity plan and deadline timelines for developing guidance, holding meetings and working with stakeholders on implementation of the various provisions of the Drug Quality and Security Act.

The timeline covers project activity phases and target deadlines:

  • Guidance development and publication
  • Public meetings (target dates tbd)
  • Licensure regulations and databases
  • Additional regulations supporting unit-level tracing and other DQSA provisions

Various industry stakeholders have stated a desire to work with the FDA to accelerate the development and completion of the TH/TI/TS data exchange as soon as possible even though the FDA isn't required to complete this until November 2014.

The timeline document is available here.

To provide direct feedback to the FDA, here is the preferred email dropbox: drugtrackandtrace@fda.hhs.gov

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The FDA has announced a DQSA Request for Information related to data exchange methods and information standards to be used for compliance with the Drug Quality and Security Act.

Published on February 20th and available on the FDA website, this RFI is part of the FDA's process seeking information from industry stakeholders on ways to facilitate the creation and exchange of transaction information, history and statement. Public comments on the public docket are due within 60 days (April 21st).

In summary, the RFI's purpose:

  • We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers.
  • In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs.

Since DQSA went into law on Nov 27, 2013, the industry has been looking at various approaches for managing, exchanging, archiving and analyzing the compliance data mandated by DQSA. EPCIS event-based approaches and modifications to existing ASN data methods are two of the options being reviewed by industry stakeholders and standards bodies such as GS1.

The FDA has until November of 2014 to publish official guidance for DQSA data exchange but recent comments by the FDA and feedback from industry has suggested that the FDA will want to information as soon as practical to help industry efficiently implement DQSA compliance solutions.

TraceLink held a recent webinar looking at some of the DQSA data management and data exchange issues facing industry as companies put into place solutions to meet the product tracing and product and transaction verification regulations of DQSA.

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Brazil's ANVISA, the Brazilian Health Surveillance Agency, has published the first public hearing to discuss the creation and implementation of the National Drug Control System to use for meeting the new resolution mandating pharmaceutical serialization and drug tracking to be phased between 2015 to 2016.

The meeting is set for January 23, 2014 from 9am to 12pm at ANVISA headquarters in Brasilia, Brazil. Here is a link to more information.

The National System of Drug Control framework published on December 10th, 2013 provides for unit-level serialization and supply chain-wide drug tracking from manufacture to dispensation where each node in the supply chain maintains their own database of drug product and downstream transaction tracking data.

Our recent webinar on the regulation detailed specifics on the new regulation from serialization requirements to drug tracking capabilities that companies need to implement by December 10, 2015.

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