New Safety Features for EU Medicine
13 February 2019
As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.
EMA Launched Online Platform for Parallel Distribution
13 February 2019
EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. Starting today, 11 February, parallel distributors are required to use IRIS that was developed in June 2018 for orphan designation applications and will now be gradually rolled out to cover other regulatory and scientific procedures.
Big Pharma to Testify in High Drug Pricing Case
12 February 2019
While congressional scrutiny on drug pricing is nothing new, the prospect of some of the pharmaceutical industry’s highest-profile CEOs testifying on the issue will make for a must-watch event.
Pilot Project for Drug Supply Chain Security Act of FDA
12 February 2019
A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products FDA regulates, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in nation’s drug supply chain.
Thai Company to Build Factory in Russia
11 February 2019
The pharmaceutical company Besins Healthcare SA will build an integrated factory in Yaroslavl (250 miles north of Moscow) for producing Utrogestan, a drug to prevent premature births and miscarriages. The company’s representative office in Russia signed an agreement with the Yaroslavl Region government at the end of November. The news was announced by deputy chairman of the regional government Maxim Avdeyev at an itinerant session of the St. Petersburg International Economic Forum “Russian regions: New points of growth,” held in early December.
Russian Scientists Developed Cancer Drug
11 February 2019
Russian scientists have developed a new drug for the treatment of cancer, which is comparable to the drug whose creators were awarded the Nobel Prize last year, and its certification is expected to take place in 2019, a Russian researcher told.
Matching Personal and Company Success
08 February 2019
The biopharma industry has found itself under political and societal microscopes in recent years, as executives search for answers to criticisms about high drug prices, shortages of vital therapies, and the industry’s role in the opioid epidemic. Meanwhile, a record number of new drug approvals and the emergence of innovative therapies demonstrate the potential of bio/pharma R&D efforts.
Pharma CEOs enthuse about Trump's plan to shake up drug rebates
08 February 2019
Sweep out drug rebates for patient discounts instead? Big Pharma CEOs are all over it. A week after the Trump administration proposed ending drug rebates in federal health programs—and then urged Congress to extend that plan to commercial insurance—supply chain players are hitting back. The pharmacy benefit manager (PBM) industry has even launched an ad campaign.
New Law, Control Russian Med Products
07 February 2019
The President of the Russian Federation has signed Federal Law no. 511-FZ “On amendments to certain legislative acts of the Russian Federation”/ According to the new law, the regulator (Roszdravnadzor) has been granted a new function to carry out controlled purchases from retailers at any time without warning the retailer.
Importance of Introducing Forced Licensing in Russia
07 February 2019
Many international experts and scholars underline that excessive imbalanced protection of intellectual property can prevent development of innovations and scientific-and-technological progress. In this context, measures towards protecting intellectual property must be balanced by relevant opportunities, - stated Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev at the X Gaidar Forum.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
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The overall mortality rate of the population in Russia decreased by 7% in 2023
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Russia to collaborate with Hungary and Serbia in nuclear medicine
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