U.K. Early Access Scheme Now Open To All Comers, But Smaller Firms May Be Scared
This article was originally published in The Pink Sheet Daily
MHRA will not limit the number of drugs that could be awarded the designation, but the lengthy, expensive application process could effectively limit the number of small firms that can take advantage of it.
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An agreement with the European Medicines Agency likely would be necessary for therapies designated as breakthroughs to ensure expedited clinical program would be accepted in both jurisdictions.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.
The EMA has recommended suspension of some 700 drug formations linked with Indian clinical trials company GVK Biosciences, but assures national agencies that this won’t result in shortages or safety issues.