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EMA Drug Identification Implementation

EMA announced the establishment of a task force for implementing international standards for the identification of medicinal products (IDMP) in early February. The task force creation follows from the finalization of ISO IDMP standards in 2012. Implementation guidelines are expected to be available in 2016.

Monthly Update, August-September 2014

In focus are: ● a significant proposal from prominent industry experts on revising the CMC submission paradigm to help spur transparency, QbD and continuous improvement, along with FDA reviewer comments on the proposal ● a series of new FDA guidances and an EU initiative on the generic drug review process ● Amgen’s MS-based “multi-attribute methodology” initiative to streamline biotech development and QC, and ● the Rx-360 keys to a strong supply oversight program and how Amgen is applying them....

Transparent Discussions, Long-term Relationships and Global Event Monitoring Mark Amgen’s Supply Oversight Program

Detailed, transparent technical discussions with suppliers, long-term supplier relationships, and a wide-ranging event monitoring system are three prongs in Amgen’s intensive effort to avoid supply disruptions and improve quality assurance....

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....

FDA and Customs Announce “Trusted Trader Program”

In mid-June, FDA and the US Customs and Border Protection (CBP) announced the launch of a new “Trusted Trader” program meant to expedite the import of products made by companies that are known to meet a quality selection standard. Participants in the program will be given incentives such as exemption from “non-intrusive” inspections. To qualify, participants […]

FDA Issues Draft Guidance on Identifying Suspect Drugs

In early June, FDA announced the release of a draft guidance for industry on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” This is the first guidance issued under Title II of the Drug Quality and Security Act (DQSA) (IPQ January 23, 2014). It advises drug supply chain stakeholders on how […]

EMA Issues 2013 Annual Report

In late April, EMA published its 2013 annual report, which notes the recommending of 81 medicines for approval for human use, compared to 57 in 2012. The annual report also highlights some of the initiatives and achievements from 2013, including its implementation of the Falsified Medicines Directive (see IPQ July 29, 2013).

HDMA Publishes Guidance on Distributor Compliance with DQSA

In late April, the Healthcare Distribution Management Association (HDMA) published a guidance meant to help distributors comply with the drug supply chain security provisions of DQSA.

The Global Ingredient Archival System (GinAS) Progressing

A progress report on the “Global Ingredient Archival System” (GinAS) will be presented at the IPEC/ExcipientFest conference in late April. The system is being developed through cooperation between NIH, FDA, and industry with the intent to “provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation.”

EC Publishes Q&A on GDPs

In late March, the European Commission published a “question and answers” (Q&A) related to its new guideline on Good Distribution Practice for medicinal products for human use, which went into effect in November 2013. The document contains 25 Q&As. The questions focus on: ● competence and training of personnel ● segregation of products ● temperature […]
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