International Pharmaceutical Regulatory Monitor

Clinical trial sponsors would be able to submit their study protocols and trial results to a single portal managed by the European Commission under a proposed overhaul of the EU’s Clinical Trial Directive (CTD).

The European Commission (EC) has accused two brand drugmakers of violating antitrust rules by engaging in “pay-for-delay” agreements with a slew of generic companies, sending both the brand and generic companies “Statement of Objections” notices.

Drugmakers whose products are authorized in the EU can expect regular, risk-based and independent audits of their pharmacovigilance systems, and they should be prepared to communicate any safety risks with regulators and health professionals, according to two new guidelines related to the 2010 pharmacovigilance law that took effect July 2.

Drugmakers can now use electronic applications when filing an initial marketing authorization, variation or renewal application in Europe.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) are harmonizing their drug good manufacturing practice (GMP) guides to facilitate the flow of shared inspection data.

Negotiations on the future of UK pricing and reimbursement policies for brand drugs will begin in September, according to a joint statement by the Department of Health and the Association of the British Pharmaceutical Industry (ABPI).

Drugmakers may be able to sell certain drugs for unmet needs in the UK before they are approved, thanks to a developing early access program.

In what may prove to be the final leg of China’s four-month crackdown on fake drugs, Chinese police in 31 provinces have seized more than $180 million worth of counterfeits and arrested about 1,900 people related to counterfeit production, according to China’s Ministry of Public Security.

Drug manufacturers in the Indian states of Haryana and Uttar Pradesh are more likely to produce substandard or falsified drugs than those in more regulated Indian states, an expert tells IPRM.

Chinese-made drugs approved by the World Health Organization (WHO) are seven times more likely to be substandard, degraded or counterfeit than similar Indian-made drugs approved by the WHO, a new study finds.

Eighty percent of drugs consumed in the Middle East are currently imported, but governments across the region are trying to change that by boosting domestic manufacturing and joint ventures and licensing deals, according to Frost & Sullivan’s analysis of the Gulf Cooperation Council (GCC) pharmaceutical market.

With support from the Brazilian government, Mozambique has launched an antiretroviral factory that could reduce the East African nation’s reliance on imported antiretrovirals.

Foreign drugmakers or their Indonesian distributor or wholesaler would need to obtain a certificate of importation (SKI) each time a supply of drugs is imported into the country, under a draft regulation issued by the National Agency of Drug and Food Control (NADFC).

Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research-savvy, developed nations, a new study concludes.

A new study shows the U.S. outpaces Europe in approving new cancer drugs, but that lead could be in jeopardy under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), an expert tells IPRM.

The International Conference on Harmonisation (ICH) is recommending that U.S., European and Japanese pharmacopoeial texts related to the bulk density and tapped density of powders be used interchangeably in those regions.

An international coalition of pharma supply chain stakeholders is calling on the U.S.-based accreditor of internet domain name registrars (DNRs) to do more to combat illicit online sales of prescription drugs.