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Meaningful discussions at 9th International Summit of Heads of Medicines Regulatory Agencies

24-11-2014

Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the delegates of Canada,…

BrazilCanadaChinaPharmaceuticalProductionRegulation

Beximco Pharma receives GMP approval from Health Canada

Beximco Pharma receives GMP approval from Health Canada

24-11-2014

Bangladeshi drugmaker Beximco Pharma has received Good Manufacturing Practices approval from Health Canada,…

BangladeshBeximco PharmaceuticalsCanadaGenericsProductionRegulation

Stronger punishments for production and sale of fake drugs in China

18-11-2014

Chinese authorities will hand out harsher punishment for the production and sale of fake and substandard…

ChinaMarkets & MarketingPharmaceuticalProductionRegulation

Russian government to start checks for GMP compliance of domestic drug producers

Russian government to start checks for GMP compliance of domestic drug producers

18-11-2014

The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug…

PharmaceuticalProductionRegulationRussiaRussian government

Pharma serialization: Is our industry on the brink of a mass extinction event?

Pharma serialization: Is our industry on the brink of a mass extinction event?

18-11-2014

Former AstraZeneca serialization expert, Ian Haynes asks whether the fact that many pharma companies…

Markets & MarketingPharmaceuticalProductionRegulation

ISPE unveils plan to prevent drug shortages

16-10-2014

Regulators from the European Medicines, the US Food and Drug Administration and the UK’s Medicines…

GlobalMarkets & MarketingPharmaceuticalProductionRegulation

FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

UK Bioscience Forum: Incentivize investors to hold their investment for more than 10 years

08-10-2014

One of the main messages from the keynote speech at the UK Bioscience Forum by Paul Drayson, chief executive…

BiotechnologyLegalLicensingPatents & Trade marksProductionRegulationResearchSocial IssuesUK

Hospira warned by FDA over Australian manufacturing facility

Hospira warned by FDA over Australian manufacturing facility

02-10-2014

USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and…

AustraliaGenericsHospiraProductionRegulationUSA

Compromised vials of Roche's MabThera found in Germany

Compromised vials of Roche's MabThera found in Germany

15-09-2014

Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had…

GermanyHerceptinLegalMabTheraOncologyPharmaceuticalProductionRegulationRoche

Proposal to expand the quality control of medicines sold in Brazil

Proposal to expand the quality control of medicines sold in Brazil

18-08-2014

Brazilian House Bill 6763/13 introduced by Gorete Pereira (PR-EC) sets the standards to ensure the quality…

BrazilPharmaceuticalProductionRegulation

Brazil plans to update the regulatory framework, expand production of medical products

Brazil plans to update the regulatory framework, expand production of medical products

15-08-2014

The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product…

BrazilFederal governmentPharmaceuticalProductionRegulation

Russia tightens responsibility for sale and production of counterfeit drugs

Russia tightens responsibility for sale and production of counterfeit drugs

30-07-2014

The Russian government has significantly tightened responsibility for the sale and production of counterfeit…

Counterfeit consumer goodsCounterfeit medicationsMarkets & MarketingPharmaceuticalProductionRegulationRussiaRussian government

US regulatory warnings on drug producers extend well beyond India

US regulatory warnings on drug producers extend well beyond India

14-07-2014

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical…

CiplaDr Reddy's LaboratoriesGenericsIndiaLupinProductionRanbaxy LaboratoriesRegulationSun PharmaceuticalUSA

FDA licenses Novartis facility to produce cell-culture influenza vaccines

FDA licenses Novartis facility to produce cell-culture influenza vaccines

16-06-2014

The US Food and Drug Administration has licensed Swiss pharma major Novartis’ manufacturing facility…

FlucelvaxNovartisPharmaceuticalProductionRegulationUSAVaccines

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

Ranbaxy’s Toansa plant assessment concluded: no risk to public health, EU view

05-06-2014

European regulatory authorities have finalized their assessment of reported non-compliance with Good…

EuropeGenericsIndiaProductionRanbaxy LaboratoriesRegulation

Boehringer resolves FDA manufacturing facility concerns

Boehringer resolves FDA manufacturing facility concerns

03-06-2014

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter…

Boehringer IngelheimFood and Drug AdministrationGermanyPharmaceuticalPharmaceutical sciencesProductionRegulationResearchUSA

Wockhardt target for fresh FDA concerns over US unit

Wockhardt target for fresh FDA concerns over US unit

28-05-2014

Indian drugmaker Wockhardt is facing fresh concerns from the US Food and Drug Administration over processes…

Clinical researchHealth Medical PharmaIndiaManaging directorPharmaceuticalPharmaceutical sciencesProductionRegulationUnited StatesUSAWockhardt

Indian regulator seeks to address the nation’s substandard drugs problem

Indian regulator seeks to address the nation’s substandard drugs problem

22-04-2014

In what is something of an indictment of India’s pharmaceutical industry, the Drug Controller General…

Asia-PacificIndiaPharmaceuticalProductionRegulation

Global Fund taps pharmaceutical expertise in China

02-04-2014

The Global Fund is deepening its partnership with China by tapping the expertise of Chinese pharmaceutical…

Anti-viralsAntibiotics and Infectious diseasesChinaGlobalMarkets & MarketingPharmaceuticalProductionRegulation

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

Sun Pharma latest Indian generic drugmaker to fall foul of US FDA

14-03-2014

Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration…

Asia-PacificGenericsIndiaProductionRegulation

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

FDA issues CRL on empagliflozin, noting manufacturing deficiencies

05-03-2014

There was disappointment today for US drug major Eli Lilly and family-owned German pharma firm Boehringer…

Boehringer IngelheimDiabetesEli LillyempagliflozinNorth AmericaPharmaceuticalProductionRegulationUSA

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