China’s updated National Essential Drug Lists (NEDL) were published on March 15th, 2013 and came into force on May 1st 2013. The 2012 version of the NEDL includes 520 drug molecules on it, including 317 chemical drugs and biological products with 850 dosage forms. Oncology drugs, human insulin products and drugs for blood diseases are some of the new medicines added to the 2012 NEDL.

On May 9th, the China Food and Drug Administration (CFDA) announced the new drug serialization and traceability reporting deadlines for these added medicines. They include:

• November 30, 2013: 2012 NEDL drug products that are domestically packaged (i.e. w/in China) need to be serialized and reported upon to the CFDA.
• March 31, 2014: 2012 NEDL drug products that are packaged outside of China and imported into the country will need to be serialized and reported upon to the CFDA.

The new NEDL products, like the 2009 NEDL list drugs and the Provincial Essential Drug List medicines which have deadlines throughout 2013, all have similar requirements for acquiring serial numbers from the CFDA, applying the serial numbers at the case and unit package level and reporting on various commissioning and inventory movement transactions across the supply chain.

TraceLink and special guest David Colombo of Eli Lilly recently gave a detailed explanation of the deadlines and the operational and technical requirements for companies in the supply chain with respect to China serialization and traceability reporting compliance.

You can watch a streaming replay here: China Serialization Webinar

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The Director General of Foreign Trade (DGFT) in India has announced that India has deferred primary level (e.g. blister pack) barcoding for track and trace of exported pharmaceuticals one year to July 1, 2014. The original date of implementation for this requirement was to have been July 1, 2013.

This was the third phase of serialization and barcoding of pharmaceuticals manufactured/packaged in India and destined for export. The previous two phases for tertiary and secondary (unit or package) level serialization were implemented in 2012.

The DGFT described the change in the public notice no. 54(RE-2012) published on April 5th. Link to the notice. Navigate to the Public Notices section, Public Notices 2012-2013 and click on the link for notice 54(RE-2012)/ 2009-2014,

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Brazil has announced a new drug serialization and traceability system. The National System of Drug Control proposal published this week by ANVISA essentially provides for serialized drug identity and supply chain-wide drug traceability from production to dispensing where each node in the supply chain maintains their own database of product and transaction information.

The proposal has a 180-day implementation timeline for manufacturers and 1 year for the rest of the supply chain participants, to start upon publication of the final regulation. The proposal is now open for a 30 day comment period with final publication date to follow at some point thereafter.

Complete analysis of the serialization and traceability requirements is underway but below is an initial snapshot of the scope of the proposal.

Key Provisions

• Serialization: Serialized identification on secondary packaging (and hospital packs), using a 2D DataMatrix, which includes ANVISA drug registration number, unique randomized serial number, lot number, expiration date. These combine to form the ANVISA Unique Identifier of Medicines (IUM).
• Supply Chain Transactions: Tracing and capture of all product movements from point of manufacture to point of dispensation at pharmacy, including reverse logistics. Importation and transportation is also mentioned in the draft proposal although it is unclear exactly how these movements are to be captured.
• Manufacturer: Maintain in a database the following information: IUM, identification number (CNPJ) of drug recipients, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Distributor: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Pharmacy: Maintain in a database the following information: IUM, identification number (CNPJ) of companies shipping product to distributor, identification number (CNPJ) of companies receiving product from distributor, identification number (CNPJ) of carriers, date/type of drug movement, logistical packaging identifier
• Data Archival: Two (2) years after the expiration date of the drug product

Note: Although the official document mentions serialization at the secondary packaging level, it also specifically defines that the Unique Identifier and Serial Number should be encoded on the smallest unit of product marketed in Brazil. So this implies item-level serialization.

Here is the official ANVISA announcement link.

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The California Board of Pharmacy has posted the agenda for the upcoming 3/14 meeting of the Enforcement Committee and Public Meeting on E-Pedigree.

E-Pedigree Agenda Topics

• SNI: Update on proposed regulations to implement serialized numeric identifiers
• Grandfathering: Update on proposed regulations for identifying drugs which may be shipped into CA after the Jan 1, 2015 deadline without serialization and ePedigree
• 50 percent calculations: Proposed regulations on calculating the 50 percent of products each manufacturer must serialize and ePedigree by Jan 1, 2015
• Inference: Update from the Board on their proposal for regulations concerning the use of inference. Read our notes from the Feb. 2013 BoP meeting on Inference.
• Drop Ship: Discussion on the use of drop shipments in the supply chain and their ePedigree requirements
• Implementation Timelines: Presentations and questions from pharma supply chain participants on their readiness to meet the staggered implementation timeline as laid out in California state law
• Certification Process: Discussion on the certification process to comply with the ePedigree law

TraceLink will be there capturing the discussion and providing a summary for our industry friends. Here is the link to the official PDF of the meeting and agenda.

NOTE: Our CA Board of Pharmacy LIVE Q&A webinar (3/20) will bring out many of the answers and discussions which went on at the meeting. So join us!

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In the last five years we have seen a very rapid growth in recalls and drug shortages. The ramifications are not only a lack of life saving drugs for patients but also a rise in drug prices and counterfeiting. The recent issues with Avastin counterfeits and Doxil supply shortages clearly indicate the problem is growing and becoming more life-threatening. The situation keeps getting worse and the root causes need to be understood and addressed.

In parallel, we have seen the biopharmaceutical supply chain undergo massive changes based upon a fundamental change in the business model and organizational structure. Historically, biopharmaceutical companies were predominantly vertically integrated where they owned their own active pharmaceutical ingredient and bulk product manufacturing plants as well as their own packaging plants. In recent years, however, supply has become globalized and production virtualized. This has rapidly created a significant increase in the inherent risk in the supply chain. Products can now be manufactured in stages from all over the world and through a network of complex relationships. While the manufacturing network has grown in complexity the global distribution network has substantially grown in volume. China, India, Brazil and Turkey are all major growth markets, however their distribution networks are inherently vulnerable to diversion and counterfeiting. The US and EU markets are also threatened by the larger global distribution market with the diversion of counterfeits through importation or distributors engaged in illegal practices.

In order to address the growing risks in the supply chain, biopharmaceutical companies need to maintain the oversight of and collaboration with manufacturing partner companies as if they were their own plants. Many urge even greater visibility and tracking since partner companies have to manage the needs of multiple customers simultaneously. Coordination and visibility across the entire production lifecycle, including visibility into production status, quality reviews, material availability and current inventory levels, are essential to maintain the supply of quality products to the market. From a distribution perspective, China, India, Brazil and Turkey are now requiring both serialization and track and trace of products. The goal is to empower the pharmacist, the clinician and even the patient with the tools to verify the authenticity of the product before dispensation or administration. The US and EU are also moving towards comprehensive adoption of serialization, track and trace with authentication.

At TraceLink, we are working with major biopharmaceutical companies to address the need for superior collaboration, visibility, track and trace in order to achieve the supply quality, capacity and integrity required by the industry. Our approach is to create tight collaboration between supply planning, quality, logistics and manufacturing across companies in order to deliver quality products on-time and in-full. Our track and trace solutions use emerging GS1 standards being adopted by almost all countries for ePedigree and authentication delivered either through enterprise integration or mobile solutions available to patients via iPhone, Android or SMS phones.

With rapid adoption of the solutions that the industry has been developing, we can eliminate drug shortages and counterfeits from our global supply chain.

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