The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July. The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website). That is, it is a database of master data wrapped within a cloud-based service.
Last week, the National Agency of Sanitary Surveillance (ANVISA), the healthcare regulator in Brazil, published a draft of their proposed pharma serialization regulations aimed at meeting the requirements of the new law number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”). The purpose of this new publication is to solicit comments from interested parties. It is called “Public Consultation No. 311 of February 15, 2017”. This is not a final regulation—the public consultation ends on March 17, 2017, after which changes to the text, based on the feedback collected, are likely before it becomes final—but it provides us with a solid view of ANVISA’s thinking, and that amounts to a big win for the industry, and for Brazil. Now is the time to read it over and submit your comments to help make it even better. Continue reading ANVISA Reveals Draft Serialization Regulation and Asks For Comments→
A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations→
Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing. My mother and my mother-in-law both suffered from heart failure during their decline. Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”. At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect. Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition. The NDC won’t last long now, and there is no longer any excuse for inaction. The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’→
There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. Bad things happen when mistakes are made in the identification of healthcare products.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.