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10 results for: regulation-pharma
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Off-label use of medication is currently not regulated in Romania. Rather, it is up to the doctors to decide on the off-label use of a...

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Ordinance no. 280/2021, dated 3 December (entering into force on December 4, 2021) creates an exceptional criterion to be used in the...

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In its second significant recent decision addressing patent term extensions (PTEs) in Australia, the Federal Court of Australia, in Merck...

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The ABPI (Association of British Pharmaceutical Industries, the UK trade association for producers of prescription medicines) launched...

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With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union...

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On 8 July the Court of Justice of the European Union (CJEU) issued its judgement in Case C-178/20, concerning the placement on the market...

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Ethical relations with healthcare professionals are of vital importance for pharmaceutical companies. Cooperation with them results in a...

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As countries in the European Union (EU) take baby steps towards reopening businesses and ramp up COVID-19 vaccination, the pandemic and...

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The Australian Therapeutic Goods Administration (TGA) is currently conducting a public consultation on proposals to help prevent,...

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On 23 February 2021, an update was published to the British Medicines and Healthcare products Regulatory Agency's (MHRA) Guidance on the...