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Chinese authorities have organized a campaign to raise drug quality standards and hold firms accountable. In comprehensive efforts to overhaul drug quality and patient security in a rapidly intensifying market, a draft guideline was released to increase regulation of pharmaceutical production, including process management. Unannounced inspections will begin November 1, and drug manufacturers will need to report any revisions to their approved manufacturing processes, including studies demonstrating these new processes will not adversely affect drug quality. Accordingly, producers in violation of the new protocols will face suspensions of production pending approval of the new processes. The action from China follows in the wake of multiple import bans on products from Chinese drugmakers by the U.S. and Europe, warning letters and non-compliance reports for violations of good manufacturing practices, and the discovery in March of a $90 million black-market scheme involving multiple vaccines, which led to hundreds of arrests.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
