International Pharmaceutical Regulatory Monitor

Proposed legislation intended to bring sunshine to financial transactions between drugmakers and physicians in Australia has industry hopping mad.

The General Court of the European Union has issued a temporary injunction barring the European Medicines Agency (EMA) from releasing information on clinical data.

Improved transparency and better access to biosimilars and orphan drugs are key goals in an emerging blueprint for industry being developed by a panel of European pharma stakeholders.

A growing number of pivotal clinical trials — typically Phase III studies — submitted in support of drug applications in Europe are being conducted outside the region, a European Medicines Agency (EMA) report finds.

To minimize cancer risks, the U.S. Food and Drug Administration is adopting a draft global guideline on identification and control of mutagenic impurities in drugs using genotoxic or carcinogenic starting materials.

Following reports of nearly 1,000 patients receiving diluted chemotherapy treatments, Health Canada has implemented an interim solution to cover gray areas in the oversight of small compounding facilities that allows admixing to continue under strict direction.

To improve engagement between the European Medicines Agency, drugmakers and scientific committees, the agency is putting in motion organizational changes discussed late last year.

The European Medicines Agency (EMA) has adopted a concept paper on extrapolation of efficacy and safety in drug development, but some groups would like to see more details on the scope of various populations where extrapolation can be used.

The European Medicines Agency (EMA) has issued a revised industry guideline for submitting full-color packaging designs, labeling mock-ups and examples of leaflets for regulatory review.

The European Medicines Agency released a first revision of good pharmacovigilance practice (GVP) guideline, adding practical instructions for the application, description and maintenance of the EU reference date list in — and amendments to — marketing authorizations.

Acting on fresh health-risk assessments, the European Medicines Agency’s (EMA) pharmacovigilance panel is calling for an EU-wide suspension of tetrazepam-containing drugs and recommending new restrictions on the use of a pair of French-made osteoporosis drugs.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to emphasize its “earlier access” and “adaptive licensing” programs to spur innovation, according to a five-year plan released last month.

Sweeping legal reforms in China signal the country’s commitment to improving trade with the U.S., including hotbed pharmaceutical concerns such as protecting intellectual property rights (IPR) and enhanced enforcement of counterfeiting, according to a U.S. government report.

The European Medicines Agency (EMA) on May 2 published draft guidelines aimed at facilitating global development of biosimilars and avoiding unnecessary repeats of clinical trials.