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Focus On Regulation

The FDA now offers cGMP Declarations

The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. The online application makes it...

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UK MHRA consults on no-deal Brexit legislation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related...

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Selective Distribution & Online Sales: Higher Regional Court of Frankfurt confirms CJEU findings and provides further guidance

After the Court of Justice of the European Union (CJEU) had issued its landmark judgment in the Coty case1 on reference for preliminary ruling, the Higher Regional Court of Frankfurt (HRC...

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HMA-EMA’s work programme on availability of authorized medicines for human and veterinary use includes measures for Brexit

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA),...

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FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

Earlier today, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are...

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