International Pharmaceutical Regulatory Monitor

Beginning this month, drugmakers and competent authorities must report all adverse drug reactions — not just serious ones — to the EU’s centralized EudraVigilance database.

While counterproductive cross-border repackaging requirements in the EU remain a concern for drug distributors, an industry group told IPRM it is now on board with a drugmaker-backed supply chain security plan to scan all medicines at the point of dispensing.

The European Medicines Agency (EMA) is stressing the need for timely, coordinated communications between EU member states when one state learns of a drugmaker’s noncompliance with good manufacturing practices (GMPs) from a non-EU country’s regulator or from an international organization, such as the World Health Organization.

Developers of biosimilar monoclonal antibodies (mAb) must conduct nonclinical and clinical studies that compare the biosimilars with the original monoclonal antibody to detect any relevant differences between the two products, according to a final European Medicines Agency (EMA) guideline released June 15.

Clinical trials for new diabetes treatments must focus on their long-term and cardiovascular safety, according to an updated European Medicines Agency (EMA) guideline.

Drug companies will have to submit updated safety and efficacy data, as well as an updated analysis of a drug’s risks and benefits when renewing marketing authorizations in the EU, according to a European Medicines Agency (EMA) final guideline on processing renewal applications.

While total spending on drugs in the UK is predicted to grow 3.7 percent a year through 2015, brand drugmakers can expect a shrinking portion of the pie, a new industry report states.

UK sponsors of Phase I clinical trials should take out adequate insurance policies in order to accelerate ethics committee review processes and assure volunteers they will be compensated if they suffer an injury or adverse event as a result of the study, according to a new industry best practice guideline.

China has amended its intellectual property (IP) laws to allow for compulsory licenses, which could anger some large multinational drugmakers because it enables local companies to produce and export generic versions of brand drugs that have not lost their patent protection.

As with its U.S. Food and Drug Administration (FDA) counterparts, Indian regulators promise fewer clinical trials for biosimilars makers who can prove their product closely matches its reference product, new guidelines state.

The largely nonfunctional state of India’s drugs regulatory agency is causing some drug developers to pull back from conducting clinical trials in the country, John Lewis, Association of Clinical Research Organizations (ACRO) vice president of public affairs, tells IPRM.

PHILADELPHIA – As Taiwan and South Korea increasingly use health technology assessment (HTA) to sift out the costs versus benefits of new drugs, other Asian countries, such as China, are looking at ways to adopt such cost-cutting programs, a pair of recent industry surveys suggests.

Regulations on how clinical trial protocols are approved in Brazil may soon be amended to allow for swifter approvals if the protocols have already been approved by a country whose regulatory framework is recognized by Brazil, such as the U.S. Food and Drug Administration or European Medicines Agency.

PHILADELPHIA — The U.S. Food and Drug Administration (FDA) and international regulators must establish a much more collaborative framework in order to ensure the safety of the world’s drug supply chains, FDA Commissioner Margaret Hamburg says.

PHILADELPHIA — The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are ramping up their interactions so they can more easily share information on future regulatory challenges, including foreign clinical trials, pharmacovigilance and active pharmaceutical ingredients.

The U.S. Food and Drug Administration (FDA) should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, U.S. drug industry insiders urge.