Tag: Drug Quality Control

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

SID & GP gave the explanation for the term “Additional materials”

In preparation of the initiative on the acceptance of additional materials after the inspection of a foreign drug manufacturer, SID & GP submitted an explanation of the term of “Additional materials”

Russia has one of the shortest periods for expert examination of medicines

pharma manufacturing
Elena Maksimkina, the Director of the Department of Drug Supply and Regulation of Medical Devices, gave her assessment of the pharmaceutical market in Russia.

Counterfeit products will even not get into the licensed pharmacy chains

Russian State Duma adopted a bill on labeling of medicinal products with Data Matrix labels. This procedure will become mandatory from January 1, 2020

Russia approves the mechanism for introducing the medicines into circulation

A draft federal law on the introduction of medicinal products for human use into civil circulation was prepared by the Russian Ministry of Health