Tag: Drug Quality Control

NICE rejected pancreatic cancer treatment by Shire

shire
The UK’s National Institute for Health and Care Excellence (NICE) finalized its determination that Shire’s Onivyde treatment for advanced pancreatic cancer is not cost-effective, and should not be cov...

Bosnalijek achieved Russian GMP certification

bosnalijek
Bosnalijek became one of the first companies operating in Russia with European localization of manufacturing that had its application approved by the Russian Ministry of Industry and Trade. The GMP...

CHMP recommended authorisation of Novo Nordisk drug

Novo Nordisk
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of Refixia (nonacog beta pegol,...

EMA put off the registration of more than 300 generic medicines

EU flag
The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites...

U.S. prohibited Indian pharmaceutical factory

fda office
U.S. health regulators have banned a drug production site in India belonging to Divi's Laboratories Ltd due to manufacturing violations, sending the company's shares down to a near three-year low. ...

Pfizer drug obtained marketing authorization in EU

pfizer
Pfizer Inc. announced that the European Commission (EC) has approved XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) oral tablets in combination with methotrexate (MTX) for the treatment of moder...

Roszdravnadzor withdrew 1938 series of medicinal products in 2016

development
The Federal Service for Surveillance in Healthcare released a draft report “On the results of the work of the Federal Service for Surveillance in Healthcare in 2016, Plans for 2017 and Planning Period...

Investigation on counterfeit medicines takes place in China

fake drugs
Counterfeit batches of Crestor brand lipid-lowering drugs contained ingredients from Chinese pharmaceutical producers, Minister of Health and Welfare Chen Shih-chung said after being subjected to a ba...

Roszdravnadzor quality control laboratory in Krasnoyarsk admitted to GEON

lab
The meeting of Advisory Group of the General European OMCL Network (GEON) held on March 1-2, 2017 in Strasbourg decided to admit the Krasnoyarsk branch of the FSBI “Information and Methodological Cent...

Counterfeit drugs were revealed in pharmacies of Armenia

armenia
Counterfeit medicinal drugs were revealed in Armenia – antibiotic Ceftriaxone-Asteria (1g) and anti-hypertensive drug Prestance (5mg/10mg, N30, batch 0590516, expiry date 11.2018). These pharmaceutica...

EU allocates €3.6 million to Belarus to support the system of drug quality control

drugs quality control
The European Union shall allocate €3.6 million to Belarus for a project to strengthen the drug quality control. This information was published on the website of the Ministry of Health of Belarus, BelT...

Guidelines for participants of the drug labeling pilot project were issued in Russia

The Federal Service for Surveillance in Healthcare has published guidelines for participants of the pilot project on drug labeling with control (identification) signs (CIS) and monitoring of certain t...

Russia has developed a virtual testing technology for anticancer drugs

lab research
Russian scientists have developed a program for virtual testing of anticancer drugs and selection of individualized cancer chemotherapy for cancer patients, according to RIA Novosti with reference to ...