Tag: Drug Quality Control

Russia establishes its National Quality Infrastructure Council

On March 14, Denis Manturov, the Russian Minister of Industry and Trade, chaired a meeting of the State Commission on Counteraction to Illegal Circulation of Industrial Products.

Few cases of counterfeit drugs to get into circulation via internet in Russia

counterfeit drug
The amount of substandard medicines available on the market has been halved in 2017, while some falsified drugs get into circulation via the Internet, said Mikhail Murashko, the Head of Roszdravnadzor.

US FDA warned OTC drug manufacturers from China and Hong Kong

The US Food and Drug Administration released warning letters sent to two over-the-counter drugmakers in China (Zhejiang Ludao Technology) and Hong Kong Zhejiang (Nan San).

EMA accepted the resubmission for review of Neulasta biosimilar

STADA Arzneimittel AG was informed by Gedeon Richter Plc. that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed biosimilar to Amgen's Neulasta (pegfilgrastim).

Russian authorities will subsidize execution of drug circulation monitoring system

On February 23, 2018, the Russian Prime Minister signed a decree on the procedure for subsidizing implementation of a system to monitor the circulation of drugs for human use.

UK blockchain startup teams up with Mongolian government to stop fake medicines

fake drugs
FarmaTrust, a UK blockchain startup, has officially signed a partnership with the Mongolian government to pilot a one-year project aimed at preventing the creation and distribution of counterfeit medications.

European Comission approved Celltrion’s biosimilar cancer drug

Celltrion, Inc., a South Korean biopharmaceutical company, announced that the European Commission approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer or metastatic gastric cancer

Novo Nordisk received EU approval for diabetes drug

novo nordisk
Novo Nordisk announced that the European Commission (EC) has granted marketing authorisation for Ozempic (semaglutide) for the treatment of adults with type 2 diabetes.

Roszdravnadzor is authorized to make control purchases of drugs

The Russian State Duma adopted in the first reading a draft law that authorizes Roszdravnadzor to make control purchases, which will allow to combat the sales of substandard medicines

EMA accepted the submission of GW Pharmaceuticals cannabinoid

european medicines agency
GW Pharmaceuticals, a biopharma company focused on developing therapeutics from its cannabinoid product platform, announced that the EMA has accepted for review the Marketing Authorization Application for Epidiolex

Russia is preparing criminal code amendments for counterfeit products

The Russian Ministry of Health began to prepare a draft law on amendments to the Criminal Code of the Russian Federation in order to fight the circulation of falsified, counterfeit, substandard, and unregistered medicinal products.

European Comission published a report on falsified medicines

European comission published a report on the application of penalties for those involved in the production and circulation of falsified medicines published. The report shows a wide variation in penalties across the EU.

CHMP gave a positive opinion for Chiesi’s orphan drug

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lamzede

European Commission approved Amgen and Allergan’s biosimilar

cancer drugs
Amgen and Allergan plc. today announced that the European Commissionhas granted marketing authorization for MVASI® (biosimilar bevacizumab)

EEC has approved the quality guidance for modified-release drugs

At its meeting held on January 16, the Board of Eurasian Economic Commission adopted a number of decisions in the area of technical regulation and customs administration

Finland takes out Velcade cancer drug from hospitals

fake drugs
Finnish pharmaceutical regulator Fimea has ordered hospital staff to stop the use of the cancer drug Velcade because it found that several batches of the drug were counterfeit