Good afternoon good people,
Thought the board here should be aware of the following "new approach to COV19" by our cousins across the Atlantic:
***
The UK no longer participates in the European Medicines Agency, the country’s drug regulator is getting creative in trying to attract top biopharma companies to submit applications to the EU and UK separately.
As part of this creative push, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s standalone medicines and medical devices regulator, last week unveiled a new accelerated drug approval pathway, known as the Innovative Licensing and Access Pathway (ILAP).
Drugmakers interested in the ILAP must first complete an “Innovation Passport” application (not be confused with the promising innovative medicine (PIM) designation) to explain how the condition to be treated is life-threatening or whether there’s a significant public health need.
***
Directly from the MHRA (note the caps):
"The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope. This designation is linked to a portfolio of activities through the creation of a product-specific Target Development Profile.
The evidence required for a product to fulfil the criteria will depend on where in the development pathway the product is and CAN BE BASED ON NON-CLINICAL DATA."
See link to MHRA notice here:
https://www.gov.uk/guidance/innovative-licens...ss-pathway
Astra Zeneca's (UK champion BP) vacc is a disaster. Biden administration is increasing orders for Pfizer and J&J vaccines thus limiting available product for export markets (UK and Eurozone). UK and Eurozone have the highest prevalence of new variants and thus higher rates of new outbreaks and thus lockdowns= worsening economy = shorter political half life for elected leaders.
Who thinks Mahboob is in London and UK will be our first paying customer?
(Hand raised)
Stay safe,
TSOV
Thought the board here should be aware of the following "new approach to COV19" by our cousins across the Atlantic:
***
The UK no longer participates in the European Medicines Agency, the country’s drug regulator is getting creative in trying to attract top biopharma companies to submit applications to the EU and UK separately.
As part of this creative push, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s standalone medicines and medical devices regulator, last week unveiled a new accelerated drug approval pathway, known as the Innovative Licensing and Access Pathway (ILAP).
Drugmakers interested in the ILAP must first complete an “Innovation Passport” application (not be confused with the promising innovative medicine (PIM) designation) to explain how the condition to be treated is life-threatening or whether there’s a significant public health need.
***
Directly from the MHRA (note the caps):
"The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope. This designation is linked to a portfolio of activities through the creation of a product-specific Target Development Profile.
The evidence required for a product to fulfil the criteria will depend on where in the development pathway the product is and CAN BE BASED ON NON-CLINICAL DATA."
See link to MHRA notice here:
https://www.gov.uk/guidance/innovative-licens...ss-pathway
Astra Zeneca's (UK champion BP) vacc is a disaster. Biden administration is increasing orders for Pfizer and J&J vaccines thus limiting available product for export markets (UK and Eurozone). UK and Eurozone have the highest prevalence of new variants and thus higher rates of new outbreaks and thus lockdowns= worsening economy = shorter political half life for elected leaders.
Who thinks Mahboob is in London and UK will be our first paying customer?
(Hand raised)
Stay safe,
TSOV
4
