Counterfeits or substandard generics? Clash over definitions roils global anti-counterfeiting initiative. WHO IMPACT members divide over conflicting goals: protecting brands from counterfeits; protecting generics from being branded as counterfeits; and protecting emerging markets from substandard generics. Blowup over Dutch customs seizures. IMPACT begins to regroup as anti-counterfeiting regulatory landscape grows increasingly complex. U.S. pursues slow-tracked trace-and-trace; California e-pedigree stymied. The E.U. advances with pharmacy verification approach, registers a success with EFPIA pilot. Council of Europe works to criminalize counterfeit drugs. USP and AID minilabs would empower developing regulators. One third of antimalarials were substandard. Nigeria enables consumers to check for counterfeits by cell phone. Baxter takes layered approach. A pressing need for on-dose protection seen, but it must be covert. The day of mass serialization will arrive, but there will be no panacea.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.
The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.
The Council of the EU’s vision for the pharma reform package includes a stronger role for member states regarding the supply of medicines and the prevention of indication-stacking for orphan drugs.
