On 1 September, the Medicines and Healthcare products Regulatory Agency (MHRA) released a tranche ofnew Brexit guidance. The guidance covers a broad range of subjects, such as: Clinical trials Medical devices Licensing of Medicinal Products (including guidance on conditional marketing authorisations, ...
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advicehttps://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice Reference Medicinal Products (RMPs)https://www.gov....
6.1The Scientific Advice document reveals that Celixir were requesting the EMA’s opinion on whether their cell product could be considered for conditional marketing authorisation on the strength of the data from the Greek trial. It appears that Celixir provided misleading information to the ...
Its human medicines committeegranted a conditional marketing authorisationfor the vaccine in people aged 18 and over after an assessment of quality, safety, and efficacy. Authorisation for EU countries followed that from the US on December 18, Canada on December 23 and Israel on January 4. Vaccine...
detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. Elafibranor is currently undergoing review by NICE and was granted conditional mark...
detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. Elafibranor is currently undergoing review by NICE and was granted conditional marketing authorisation by the EMA. Elafibranor was developed by GENFIT. Ipsen licensed the...