Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

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 […]

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.

FDA Accredits GS1 and HIBCC to Issue Unique Device Identifiers

GS1 and HIBCC have been named by FDA as two of the organizations able to assign Unique Device Identifiers (UDI). The UDI rule, issued in September 2013, requires the label of medical devices, including combination products that contain devices, to include a UDI. The labeler must submit product information concerning devices to FDA’s Global Unique […]

U.S. and Five Other Countries Await Listing Decision Under EU’s Falsified Medicines Directive

The U.S. is among six countries with applications pending at the European Commission (EC) to be listed as a third country with GMPs equivalent to those in force in the EU, which allows continued export of active pharmaceutical ingredients (APIs) into the EU without a company-specific certification under the terms of the EU’s Falsified Medicines […]

USP Releases New Draft General Chapter on Good Distribution Practices and Supply Chain Integrity

USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain. The formal proposal will be published in March/April issue of Pharmacopeial Forum.  Comments are due by May 31. An advance […]

FDA Releases Report on Drug Diversion and Counterfeiting Cases

This news brief is provided as a service to IPQ subscribers. Subscribers click here. For subscription/license information, click here.

Congressional Bills Address FDA Supply Chain Oversight

This news brief is provided as a service to IPQ subscribers. Subscribers click here. For subscription/license information, click here.

Increasing Cargo Theft of Pharmaceuticals May Have Brand Impact and Result in Recalls

The significant increase in pharmaceutical cargo thefts in the US carries hidden consequences for drug firms beyond the dollar loss they incur, including damaged reputations and the need to perform product recalls....

FDA Shares Concerns, Expectations Regarding Pharma Cargo Thefts

FDA sent a letter to medical companies expressing concern about the increase in cargo thefts of FDA-regulated drug products, and clarifying its expectations from companies and the agency’s role when thefts occur....

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

.
● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — the key CMC and GMP developments in the US, Europe and internationally

● “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern

Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library

.

 

CLICK HERE  for the IPQ Monthly Update – June 2020 in Review


IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence

.

©2020 IPQ Publications