July 13, 2012 | Vol. 4 No. 28
China is expected to reclassify some in vitro diagnostic (IVD) and medical imaging devices to lower-risk categories as part of a reform of its classification system that began in 2009, industry experts say.
The European Medicines Agency (EMA) is stressing the need for timely, coordinated communications between EU member states when one state learns of a drugmaker’s noncompliance with good manufacturing practices (GMPs) from a non-EU country’s regulator or from an international organization, such as the World Health Organization.
Cephazone Pharma has received a closeout letter, resolving a 2011 warning letter that cited GMP violations and tardy responses to FDA inspection findings.
Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says.
Compared with the EU and other international markets, medical devicemakers face greater regulatory uncertainty and a more burdensome approval process for their products in the U.S., an industry survey concludes.
Exemplar Pharmaceuticals, a contract manufacturer of nasal sprays and other aerosol-based drugs, was handed a Form 483 for process control deficiencies tied to filling foul ups.
While counterproductive cross-border repackaging requirements in the EU remain a concern for drug distributors, an industry group said it is now on board with a drugmaker-backed supply chain security plan to scan all medicines at the point of dispensing.
The European Medicines Agency (EMA) is stressing the need for timely, coordinated communications between EU member states when one state finds out about a drugmaker’s noncompliance with GMPs from a non-EU country’s regulators or from an international organization, such as the World Health Organization.
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