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European Medicines Verification Organisation Established

In mid-February, EFPIA, along with EGA and EAEPC, announced the establishment of the European Medicines Verification Organisation (EMVO). EMVO is designed to provide end-to-end verification of drugs from manufacture, through distribution to patients by creating an infrastructure for complying with EU’s Falsified Medicines Directive.

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....

Three FDA Guidances on Drug Supply Chain Security Act (DSCSA)

In late November and December, FDA issued three more guidances on implementing the provisions of DSCSA – the track and trace (Title II) component of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). Title I of DQSA addresses compounding. The three new DSCSA guidances cover:● the situations in which FDA will delay […]

Draft DQSA Track-and-Trace Q&A

In early October, FDA released a Q&A on provisions of Title II of the Drug Quality and Security Act (DQSA), which covers track-and-trace. The Q&A addresses how Title II will affect state standards, as well as when certain requirements come into effect. [For more on DQSA implementation see IPQ January 23 2014.]

Brazil Guidance on Track-and-Trace Requirements

Brazil’s regulatory authority ANVISA has published a guidance on the reporting requirements for its medicine track-and-trace system (see IPQ “News in Brief” January 31, 2014), which is due to come online in 2016. It specifies that transactions must be reported to the regulator by uploading XML files to its website detailing events such as packaging, […]

IPQ Monthly Update, July 2014

IPQ’s coverage during July focused heavily on the efforts worldwide to address the threats that loom along the global supply chain to the quality of the products that patients receive. Included in the July Monthly Update are stories addressing: ● APEC’s broad-based, multi-faceted initiatives ● pharmacopeial modernization and harmonization efforts, and ● FDA’s track and trace implementation. Also in this issue are valuable insights from FDA’s microbiology review staff on: ● top micro deficiencies in applications, and ● upgrading micro methods and processes....

Rx360 Launches Traceability Work Group

Rx360 announced the establishment of a new collaborative work group in early August to “support serialization and track and trace legislation that is evolving globally.” The work group will focus on developing conceptual models for the interoperable exchange of information needed to comply with global regulations, and is seeking participation from anyone with knowledge of: […]

India Changes Date for Barcoding Implementation

India, in early August, extended its deadline for the barcoding of pharmaceutical packaging. The labeling being implemented is meant to aid in the track and trace of drug product in order to better secure the supply chain. The requirements for serialization were changed last month (IPQ “News in Brief” July 1, 2014) but the date for […]

FDA Cautioning Industry on Looming Initial Track and Trace Deadlines

FDA is cautioning industry stakeholders that the initial implementation phase for the track and trace provisions in the Drug Quality and Safety Act (DQSA) is rapidly approaching, with interoperable product transaction requirements for manufacturers, distributors, and repackagers kicking in on January 1, 2015....

APEC’s Assessment of Gaps in Supply Chain Regulation Reveals Surprising Differences in Country Approaches

The assessment by the Asia Pacific Economic Cooperation (APEC) organization of the gaps in the ability of regulatory agencies to address the problems of an international supply chain has revealed some surprising differences in their practices....
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