The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”

REUTERS. Jul 22, 2016// President Barack Obama on Friday signed into law a measure that pledges greater efforts to protect drug-dependent newborns and assist their parents. The Comprehensive Addiction and Recovery Act also stresses drug treatment and overdose prevention to help stanch the nation’s heroin and opioid drug epidemic.

Obama said in a statement that 78 Americans die from opioid overdose every day, and noted that the legislation included only modest steps to address the epidemic.

The rules regulating the emerging commonpharmaceutical market of the Eurasian Economic Union (EAEU) shall not require an unconditional recognition of GMP (Good Manufacturing Practice) Certificates issued by the countries that are non-members of the EAEU. To assure safety, quality and efficacy of medical products produced by third countries, pharmaceutical manufactures will have to follow the new EAEU regulations.

The news was announced by Arman Shakkaliev, the Director of the EEC Technical Regulation Department, in the course of a working meeting with Luis Portero, the Head of the Department of Economy and Trade of the Representative Office of the European Union in Russia.

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability.

Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record.  Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.

REUTERS. Jul 9, 2016// As China's medical bills rise steeply, outpacing government insurance provision, patients and their families are increasingly turning to loans to pay for healthcare, adding to the country's growing burden of consumer debt. 

While public health insurance reaches nearly all of China's 1.4 billion people, its coverage is basic, leaving patients liable for about half of total healthcare spending, with the proportion rising further for serious or chronic diseases such as cancer and diabetes.

The Director of the Department of Technical Regulation and Accreditation of the EEC, Arman Shakkaliev, spoke to employees of the Group - industry representatives of the global market for medical products - about the key tasks of the Commission related to the circulation of medical products in the common market of the Eurasian Economic Union (EAEU) at the headquarters of the Eurasian Economic Commission (EEC) in Moscow.

In general, the Eurasian Economic Commission (EEC) has completed formation of regulatory framework of the Eurasian Economic Union (EAEU) for launching the common market of medical products. On the legal portal of the EAEU, Rules for registration and examination of safety, quality and efficacy of medical products approved by Decision of the EEC Council No. 46 of February 12, 2016.

The document establishes legal regulation of relations in the field of applying mandatory requirements for medical products and conducting by the EAEU countries the examination for compliance with these requirements.