International Pharmaceutical Regulatory Monitor

The European Parliament’s public health committee May 29 adopted draft rules calling for simplified clinical trial reporting procedures and enhanced authority for European Commission inspections.

Starting in September, sponsors in the UK would need to register clinical trials within an agreed time frame as a condition for research ethics committee (REC) approval, under a plan being developed by the government’s Health Research Authority.

The Canadian government has established a new public database of authorized clinical trials.

Effective June 5, drugmakers must declare their reasons for withdrawing, requesting to withdraw, temporarily or permanently suspending, or not renewing marketing authorization of a centrally authorized drug in the EU.

Sweeping legal reforms in China — including stronger protections for intellectual property rights (IPR) and enhanced enforcement of counterfeiting — signal the country’s commitment to improving trade with the U.S., a new U.S. government report states.

Former U.S. trade officials and pharma industry experts called on Congress May 14 to investigate Indian trade policies that impede innovation.

China and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive.

The same good manufacturing practices that finished-dose drugmakers in Canada are required to follow soon will apply to all active pharmaceutical ingredients used in the country.

The European Medicines Agency May 8 published recommendations for drugmakers on the use of phthalates and parabens, urging consideration of patient populations.

Language on traceability requirements in the EU’s 2007 regulation on innovative “advanced therapies” is overly broad and should be clarified in forthcoming guidance, pharma giant Pfizer says.

Efforts to expand access to orphan drugs in Brazil got a boost from legislation introduced May 9 in the National Congress.

The European Medicines Agency May 8 released a guideline for orphan drug sponsors on how to file applications and request fee reductions under a new streamlined procedure.

After receiving generally supportive comments from industry, Australia’s Therapeutic Goods Administration and New Zealand’s Medsafe on June 4 launched their joint “early warning system” to communicate potential safety concerns with drugs and medical devices.

On May 22, Australia’s Therapeutic Goods Administration introduced revisions to administrative processes when drugmakers make minor variations to prescription drugs.

Beginning this month, drugmakers in France must begin reporting all payments and other benefits to healthcare professionals in excess of €10, including tax — about US $12.87.

Egypt’s Central Administration for Pharmaceutical Affairs has issued guidelines for determining when a change in parenteral biological preparations should be submitted as a new application or a variation.

The European Medicines Agency (EMA) has issued revisions to a 2006 biosimilar guideline, which clarify clinical and nonclinical requirements for marketing such products.