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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....

India Offers Bounty for Whistleblowers on Fake Medicines

In a mid-July circular, India’s Central Drugs Standards Control Organisation (CDSCO) announced the offer of rewards for whistleblowers who report on goods that are confirmed as “spurious, adulterated, and/or misbranded.” Rewards have been set at up to 20% of the total value of intercepted shipments of goods. The maximum value of the reward is 2.5m […]

Changes in India’s Serialization Expectations

India announced in a late June public notice that it now considers mono cartons containing strips, vials, or bottles of pharmaceutical products as secondary, rather than primary packaging, for the purposes of serialization. The Directorate General of Foreign Trade of India requires secondary packaging to carry a barcode encoding a unique product identification code, batch […]

EU Launches Genuine Online Pharmacy Logo Scheme

In late June, EC introduced a logo that will allow patients to identify authorized online pharmacies providing authentic medicines.

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 […]

WHO Releases Storage/Transport Supplements

WHO has released for review a set of supplements on its Technical Report Series, No. 961, 2011 Annex 9, which provides a “model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products.” The supplements cover: ● temperature and humidity monitoring systems for transport operations ● temperature and humidity monitoring systems for fixed […]

FDA Issues Draft Guidance on Identifying Suspect Drugs

In early June, FDA announced the release of a draft guidance for industry on “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”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 […]

UK MHRA’s Compliance Management Upgrade Includes “Risk Intelligence IT System” for Drug Inspection Targeting

U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is creating a comprehensive “Risk Intelligence IT System” for determining where to deploy its inspection resources that captures and analyzes a wide variety of inputs from industry, public, and agency information sources....

Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain

Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide....

Congressional Hearing on Counterfeit Drugs and Supply Chain

A February 27th hearing was held by the House of Representatives’ Committee on Energy and Commerce to discuss the FDA effort to combat counterfeit drugs and what additional authorities may be needed to aid this effort. Appearing at the hearing were FDA Deputy Commissioner Howard Sklamberg, Elizabeth Jungman of Pew Charitable Trusts, as well as […]
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