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Companies that want to appeal Health Canada’s ruling on a drug applications may be surprised to find their particular dispute is no longer contestable, under proposed revisions to the agency’s dispute resolution process. Read More
India’s Central Drugs Standard Control Organization has issued a uniform set of procedures that state drug authorities should follow when inspecting facilities for good manufacturing practices and issuing certificates of pharmaceutical product. COPPs are required for drugs intended for export. Read More
Generics manufacturers want an equal say at the highest echelon of the International Conference on Harmonisation, which sets standards affecting prescription drugs. Read More
The European Medicines Agency is looking for generic drugmakers to participate in a pilot program aimed at coordinating product approvals across international borders. It should also cut down on approval costs, which could translate to cheaper prices. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations closer to those of the EU. But it could be another two years before the agreement is actually implemented. Read More
Australia’s main pharma lobby is proposing changes in how its members report gifts to healthcare professionals, but at least one industry expert says the plan’s fine print would allow doctors to opt out. Read More
Drugmakers should consider the effects of price harmonization in the Persian Gulf region when deciding where to launch their products in the global marketplace, a new report concludes. Read More
India’s National Pharmaceutical Pricing Authority asked six manufacturers of generic cancer drugs to submit pricing data in advance of its setting price caps on the products, a move that one industry observer says was expected. Read More
In an effort to dispel a perception that Indian drugs are poorly made, the government is offering whistleblowers a hefty reward for providing information on spurious, adulterated and misbranded products. Read More
Recent media reports of GlaxoSmithKline’s decision to dismiss staff in China for bribes that occurred more than a decade ago are raising new questions about the drugmaker’s involvement in alleged corruption that surfaced last year. Read More
Starting next year, drug companies seeking to market products in Canada will need to provide the regulatory authority with information on proposed names, labels and packages.
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Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization. Read More