Regulatory Roundup: EMA monitors Japanese-manufactured medicines following radiation leak from nuclear power plant

EMA is working with its European and international regulatory partners to monitor and evaluate “the possible risk of radioactive contamination of medicines manufactured in Japan following the radiation leak from the Fukushima Daiichi nuclear power plant,” according to a recent EMA press release. To date, information has shown that the risk to public and animal health is small, but EMA is taking a precautionary approach, which includes putting certain measures into place for food and animal feed throughout Europe. The ultimate responsibility for safety, efficacy, and quality of products manufactured in Japan, says the release, is the holder of the product marketing authorization. Marketing authorization holders are therefore being asked to test their products for radionuclides iodine-131, caesium-134, and caesium-137 prior to exporting products out of Japan.

FDA has posted on its website the minutes from meetings between the agency and industry regarding the Prescription Drug User Fee Act (PDUFA) reauthorization. The meetings took place in January and February of this year.

FDA and EMA released on May 16, 2011, a document about how the agencies plan to work together on parallel reviews of quality-by-design based new drug applications as part of their ongoing pilot program. The document provides advice to applicants on the background and objectives of the pilot, as well on the steps that will be taken to coordinate the parallel review and related GMP inspections.