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Russia Changed the Rules for Conducting Inspections for Compliance with GMP Requirements

On September 5, Russian Prime Minister Mikhail Mishustin signed Decree No. 1361 amending the rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements, as well as issuing the certificates on the compliance of drug manufacturers with the GMP standards...[RussiaMin]

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A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity

With many companies utilizing contract manufacturing and contract laboratories, quality agreements...

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MHRA Will Work Together with Agencies from Australia, Canada, Singapore and Switzerland

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined the Australia-Canada-Singapore-Switzerland...

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Le autorità regolatorie dell'UE richiedono di testare le quantità di nitrosammine per i farmaci a base di metformina

'EMA e le autorità nazionali competenti dell'UE contatteranno tutti i titolari di autorizzazione...

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