Many major wholesalers are leading the charge for receiving aggregated data—requiring that manufacturers be able to digitally send pallet identifiers with corresponding digital details of all shipments sent to them. Without this data being aggregated, wholesale staff would have to open each pallet and manually scan each serialized product.
Brazil is a vibrant market packed with opportunities. Markem-Image is meeting the needs of our customers by combining our traditional expertise with investment in new technology writes Julio Leite, Markem-Imaje’s Regional Sales Director for Brazil and Argentina.
Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time to analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down but is a growing threat.
Near the end of 2019, there were rumors that the Russian Federation would extend its regulatory deadlines for pharmaceutical serialization and traceability past its initial January 1, 2020 deadline, which called for full serialization using Russian Crypto Codes and government reporting...
Indonesia is a country that is a collection of many islands in Southeast Asia. You may not think of Indonesia very often, but you should. Indonesia is the fourth largest country on Earth by population, behind China, India and the United States. It is the 14th largest by land area and the 7th largest when you consider land and water surface. It’s big, and it has been doing well economically for the last decade or so since the government stabilized. And they have a government-run universal health...
Earlier this year, the FDA called on the life sciences and healthcare industry to design and deliver pilot projects for an electronic, interoperable system that can identify and trace prescription drugs as they are distributed across the United States in support of the DSCSA. Systech partnered with several industry innovators to respond to the FDA’s proposal including RxTransparent, T-Systems, FarmaTrust, CryptoWerk and CalQLogic.
China’s National Medical Products Administration (NMPA) has been very active in the last year, producing documents that address various aspects of their planned pharma traceability mandate. It has been several years since the previous pharma serialization and tracing regulation was suspended. The future system described in the new final guidance documents is significantly different from that old suspended system. Where the old system avoided the use of global standards—and thus it was a...
On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...
First, allow me to set the stage with some facts:
First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings to...
