International Pharmaceutical Regulatory Monitor
October 2011 | Vol. 39 No. 10 | Full Issue in PDF Format
Drugmakers doing business in South Korea would have to renew product registrations with the Ministry of Health and Welfare (MOHW) every five years, with new fees assessed for reregistration, according to a draft MOHW proposal.
The French National Assembly Oct. 4 adopted new regulations aimed at strengthening pharmacovigilance, tightening conflict of interest rules and increasing transparency at all levels of health product regulation.
The European Commission (EC) is seeking stakeholder feedback on how to handle variations requests drugmakers submit to strictly national marketing authorities, according to a Sept. 21 consultation document. Includes the full text of Public Consultation Paper: Review of the EC Variations Regulation.
The European Medicines Agency (EMA) Sept. 30 launched a risk-based conflict-of-interest database of outside scientific experts.
A group of leading drug industry and medical research organizations is pressing the EU to enact sweeping changes in its regulatory framework for clinical trials.
Health Canada (HC) is accepting more submissions in electronic-only filing format, including requests for priority review status of new and supplemental drug applications, presubmission meeting information, drug identification number applications and biologic identification number applications.
Press releases about medicines posted on manufacturer websites and available to the public are advertisements and must include warning notices, Estonia’s State Medicines Agency says.
An international offensive against online sellers of fake and illicit drugs has resulted in the seizure of some 2.5 million pills with an estimated value of $6.3 million.
The rate of inspections by the U.S. Food and Drug Administration (FDA) has improved in recent years, but the agency still inspects “relatively few” foreign facilities compared to domestic sites, and most inspections remain unannounced, government auditors said in a Sept. 14 report.
The U.S. Food and Drug Administration (FDA) says continued evidence of systemic good manufacturing practice (GMP) problems in overseas inspections may mean drugmakers have to apply pressure on foreign partners to maintain quality.
The U.S. came more into line with international patent law Sept. 16, when President Barack Obama signed legislation implementing a first-to-file standard for patent approval.
Drugmakers may get some leeway in meeting a mandate giving them just 30 calendar days to respond to a U.S. Food and Drug Administration (FDA) notification letter proposing labeling changes.
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