European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites

CHMP began reviewing drugs tested at Indian sites in the midst of GCP's concerns

The Committee for Medicinal Products for Human Use (CHMP) undertook a review of the trial on two sites Micro Therapeutics Research Labs India Drugs. The national regulatory authorities asked the CHMP to conduct a review after the Austrian and Dutch authorities found fault with these sites during a Good Clinical Practice (GCP) inspection.

Officials visited sites in February Micro Therapy reported concerns about the survey data used to support applications for marketing authorization in the European Union. This led to 18 national regulatory bodies to ask the European Medicines Agency (EMA) to check whether the findings of the GCP inspectors affected their position on the risks and benefits of the drugs tested on the sites. The CHMP also checks whether the data generated on the sites are used to support active applications and, if so, to determine whether the origin of the results should influence their evaluation.

The review involves a centrally licensed drug, a generic copy of Eli Lilly's erectile dysfunction drug Cialis sold by Mylan. EMA drug approved two years ago on the basis of data showing that it is bioequivalent to the reference product. The review will also assess the risks and benefits of drugs approved by national authorities in light of questions about data generated at sites in the Indian cities of the Chennai and Coimbatore regulatory bodies.

Previous suggests EMA will strongly act against any medication that has been approved based on data generated incorrectly. When EMA found evidence of manipulating electrocardiogram data from GVK Biosciences, he recommended the suspension of 700 products that were based on studies conducted by contract research agency in India for approval. More recently, the agency has suspended dozens of drugs, including many sold by Novartis and Teva Pharmaceuticals, after finding flaws in how the Semler Research Center conducted bioequivalence studies.

Scottish politicians criticize MHRA on transvaginal mesh implants

Politicians have criticized the UK Drug and Health Products Regulatory Agency (MHRA) for its treatment of transvaginal mesh implants. The Scottish government has asked the National Health Service (NHS) to stop using appliances in 2014, but the products remain on the market, it is reported that more than 400 women have received implants since.

Scottish politicians discussed implants after the BBC News reported the continued use of devices. Shona Robison, the ruling Scottish National Party, adopted the debate defining the powers or lack belonging to the government and MHRA and other politicians said a report to be released early next year will contain answers to your questions. However, with a political argument that implants cause "organ damage, loss of a kidney, bladder removal, constant chronic and unbearable pain" and other side effects, the Robison argument has not Managed to soothe all other loudspeakers.

"Due to the problems we are discussing, we have tended to speak on the subject in the most cautious tones. However, last month in the Australian Parliament, Senator Derryn Hinch delivered a speech absolutely Dull in which he criticized doctors And manufacturers neglect women and compared implant mesh scandal with thalidomide, "said conservative politician Carlaw Conservative Party said." I include the MHRA in my criticism. "

MHRA examined evidence of the risks and benefits of implants in 2014 after groups representing patients affected by devices come to him. The regulator concluded that "for most women, the use of vaginal mesh implants is safe and effective." Other regulators have come to similar conclusions.In January, the Food and Drug Administration (FDA) ) Reclassified mesh implants used to repair organ pelvic prolapse (POP) and increased risk devices, but left used to treat stress urinary incontinence products in Class II.

The position of the FDA is broadly aligned with that of the MHRA, which was more unequivocally its support for the use of POP SUI mesh. Despite this, and a requirement that all patients give their prior knowledge before proceeding to an authorization of the mesh implant, the question remains political