International Pharmaceutical Regulatory Monitor
December 2011 | Vol. 39 No. 12 | Full Issue in PDF Format
A $282 million injection by the British government will aim to revitalize the nation’s biotech industry through public-private partnerships and other measures, UK Prime Minister David Cameron said Dec. 5. Includes the full text of UK Life Sciences Strategy.
The UK’s All-Party Pharmacy Group (APPG) Nov. 21 launched a full-scale investigation into ongoing shortages of government-funded prescription drugs.
Health Canada routinely misses statutory deadlines for reviewing generic drugs, over-the-counter (OTC) formulations requiring clinical review and postmarket change submissions, the auditor general of Canada says.
Guido Rasi assumed the executive directorship of the European Medicines Agency (EMA) Nov. 16, becoming its third leader in 16 years.
The European Medicines Agency (EMA) plans to clarify qualified persons’ (QPs) responsibilities during batch release when a QP is not at the manufacturing site.
As of Jan. 1, holders of European Medicines Agency (EMA) marketing authorizations for human and veterinary medicines must pay fees for type 1A variation reviews at the start of the 30-day process, the EMA says.
Starting Jan. 1, secondary packaging for all drugs exported from India must have one- or two-dimensional (1D/2D) bar codes with a unique product identification code, batch number, expiry date and serial number.
By the end of the decade nations of the Asia-Pacific Economic Cooperation (APEC) group will have aligned their regulatory review of medicines and medical devices, the APEC forum agreed.
Patients in New Zealand have access to less than half the prescription drugs available to counterparts in Australia, a new study concludes.
The Australian government is canvassing drug and devicemakers as well as contract research organizations to gauge the level of privately funded clinical research activity in the country.
Mandatory local clinical trials required to register both novel and generic drugs in Russia are largely to blame for a decline in clinical trials there, according to a recent report by the Russia-based Association of Clinical Trials Organizations (ACTO).
Drug industry intransigence is one barrier the U.S. Food and Drug Administration (FDA) faces in its effort to tighten the world’s pharmaceutical supply chain, according to a new report.
First-filer generic drugmakers that win patent challenges in U.S. district court, or are not sued by the brand company after filing an abbreviated new drug application, could be forced to share their 180-day market exclusivity under a new bill.
Drug trial sponsors developing patient-reported outcome (PRO) measures should seek U.S. Food and Drug Administration (FDA) qualification for them prior to engaging in clinical trials, and should use the measures to gauge quality of life, Janet Woodcock, director of the U.S. Center for Drug Evaluation and Research, advises.
U.S. Food and Drug Administration (FDA) final guidance on distribution of medication guides allows generic drugmakers to submit a changes-being-effected supplement to eliminate having to adopt a risk evaluation and mitigation strategy (REMS) if the REMS for the brand drug has been removed and includes only a medication guide.
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