EMA’s Adaptive Licensing Policy: Broad Enthusiasm, Sparse Details
This article was originally published in The Pink Sheet Daily
Most European health care stakeholders agree that adaptive licensing will improve access and promote innovation, but are undecided which drugs would qualify.
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Industry and regulators are showing more interest in implementing adaptive licensing in Europe. Both sides agree that increased trust and transparency could be stepping stones towards this goal.
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.