The Natural Products Association launches the first industry-driven program designed to test the purity and composition of Chinese raw ingredients, the group announces July 21. Testing of raw materials by the U.S. Pharmacopeia's Shanghai, China laboratory "represents a significant departure from the current process where U.S. companies must rely on a test by Chinese laboratories or test samples themselves in the United States," NPA says. Benefits to this system include "reduced transit times and costs; greater traceability and documentation of ingredients used in the supply chain; use of state-of-the-art technology in testing; and a systematic approach to verification," NPA states. The association opened a branch office in China last July and began developing the program shortly after, preceding the spate of problems linked to contaminated food products shipped from China, NPA says (1"The Tan Sheet" July 24, 2006, p. 3 and 2"The Tan Sheet" July 16, 2007, p. 5). NPA launched the program because there "seemed to be a logical connection to have people on the ground" to monitor and maintain product quality and reliability since China is one of the biggest ingredient sources, NPA Vice President Scientific and Regulatory Affairs Daniel Fabricant told "The Tan Sheet"...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
