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Regulatory News

In Pharma Industry Regulation section of PharmProm.Ru we cover latest Pharma News, Pharmaceutical Industry articles, Pharma Journals, Pharmaceutical articles and more.

Regulatory News

WHO revises guidance on GMPs for investigational products and R&D facilities

Techno -
WHO said the objective of the update is to align the guidance with “current expectations and trends in good manufacturing practices”.
Regulatory News

Antitrust watchdog sets maximum selling price for 50 doses of CoviVac vaccine at $297

Techno -
FAS has agreed on the maximum selling price for a new package of the CoviVac vaccine. The new form of vaccine release contains 50 doses.
Regulatory News

FAS initiated a case in the ALV supply market

Techno -
The FAS Russia has initiated an antimonopoly case against Hamilton Medical AG on the grounds of coordinating the actions of the manufacturer's official distributors.
Regulatory News

FDA warns of clinical trial results showing increased risk of death associated with Pepaxto

Techno -
Due to the detrimental effect on overall survival in the OCEAN trial, FDA is requiring the manufacturer suspend enrollment in the trial.
Regulatory News

ICH releases widely anticipated guidance on continuous manufacturing

Techno -
Three different models of continuous manufacturing are described in the draft guideline. The guideline incorporates the ICH Q7 definition of a batch to continuous manufacturing.
Regulatory News

FAS fined Bayer for improper advertising

Techno -
The FAS Russia imposed an administrative fine of 200 thousand rubles on Bayer JSC for improper advertising of the medicine Teraflex Hondrokrem Forte.
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