India’s draft e-pharmacy rules put in place a series of checks and balances to ensure that only genuine e-pharmacies engage in online sales of medicines. Registration and strict record keeping requirements, among other aspects, are mandated under the rules, though it may take a “leap of faith” when it comes to security of patient data, some experts say.
India’s draft e-pharmacy rules permit only registered e-pharmacies to conduct business in the country and specify requirements to ensure that records of drugs dispensed and patient details are maintained appropriately and safely.
The rules require all e-pharmacies to be registered with the Central Licensing Authority – the Drugs Controller General of India...
The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
