Tag: Drug Quality Control

Chinese vaccine manufacturer is fined $1.3 billion

vaccine
Chinese manufacturer of rabies vaccine was fined 9.1 billion yuan ($1.3 billion) for falsifying production records in a scandal that prompted a nationwide crackdown on the industry.

EU authorities continue investigating sartan medicines

counterfeit drug
EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management.

FAREVA will use TraceLink serialization solutions for FMD compliance

marking
TraceLink announced that FAREVA has selected TraceLink's serialization solutions to ensure compliance with the EU Falsified Medicines Directive (FMD).

SID&GP presented the inspection overview of foreign pharma manufacturers

sid&gp
Mr. Vladislav Shestakov presented a review of the results of inspections of foreign pharmaceutical manufacturers at the PharmMedCirculation 2018 conference.

CFDA representatives visited their Russian colleagues from the SID&GP

china-russia
On September 24, 2018, a delegation from the Foods and Drugs Administration of Yunnan Province (China) visited the State Institute of Drugs and Good Practices.

Merck opens GMP BioReliance testing lab in Singapore

drug-testing
Merck KGaA (Germany) announced the opening of a new 3,800-square-meter laboratory in Singapore. The new $20 million biologics testing facility is the first of its kind in Singapore.

Chinese API manufacturer refused admittance to EU inspection

api
European medicines regulators have issued a notice that an ingredient for a generic brain cancer drug made in China does not meet manufacturing standards, after inspectors were refused entry.

rfxcel updates its track and trace solution for Russia

trackandtrace
rfxcel, the global leader in track and trace solutions, releases enhancements to its compliance solution for Russia and kicks off additional customer implementations in the Russian marketplace.

India aimed to combat with counterfeit drugs using blockchain technology

blockchain
Indian policymakers in collaboration with an Indian hospital chain and a multinational technology corporation have initiated plans to deploy blockchain in the fight against counterfeit drugs.

Schreiner MediPharm created Covert-Hologram Seal for tamper protection

drug-marking
Schreiner MediPharm has developed a multifunctional Covert-Hologram Seal that offers reliable first-opening indication and tamper evidence, plus counterfeiting protection.

China announced a list of foreign drugs suitable for Priority Review

china street
China’s Drug Evaluation Center posted a list of 48 drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China.

TraceLink rolls out its Russian serialization solution

trackandtrace
TraceLink announced its Russian compliance solution, providing companies with the ability to meet requirements for serialization, traceability, and compliance reporting for all pharmaceutical manufacturers.

South Korea recalls 59 valsartan-containing drugs

counterfeit drug
South Korea’s Ministry of Food and Drug Safety ordered a recall of 59 drugs containing valsartan due to its inclusion of above-permitted levels of a chemical that could cause cancer.

Roszdravnadzor: percentage of counterfeit or substandard drugs is 0.4%

pharmacy
Less than one percent of drugs officially sold in pharmacies are fake, counterfeit or substandard. More precisely, their share is 0.4 percent, Mikhail Murashko, Head of Roszdravnadzor, said.

Chinese drug regulator launches investigation of all vaccine manufacturers

vaccine
The National Drug Administration of China (CNDA) launched a thorough investigation into all vaccine producers across the country. Chinese drug producer had violated standards in making of DPT vaccine.

Wasdell Group started serialization service

marking
The Wasdell Group, a leading partner to companies within the pharmaceutical, medical device and clinical trials industries, has launched its serialisation service ahead of the EU FMD and US DSCSA implementation deadlines.