Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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Pharmaceutical Technology

NOVEMBER 21, 2022

Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% Among the 37 member companies, 17 of them are overseas companies and 20 of them are Japanese companies with a 10%+ overseas pharma sales ratio.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

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Clinical Trials Clinical Trials Production Medicine 52

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19.

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Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. for drug safety. counterparts. J)(2) Waiver authority.

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