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Canada Patent Protections In Spotlight As PhRMA Seeks Addition To “Priority Watch List”

 
• By Brenda Sandburg

The drug industry sees a not-so-friendly neighbor to the North and wants help from the Office of the U.S. Trade Representative to get Canada to change its “promise utility doctrine.”

India is once again on the top of the pharmaceutical industry’s list of countries that do not provide enough protection of intellectual property rights. But this year it is joined by an unlikely foe: Canada.

The Pharmaceutical Research and Manufacturers of America focused on the two countries at a public hearing of the Office of...

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EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
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EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
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As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

More from Geography

Engage With HTA Body NICE Before Submitting MAA, UK Govt Tells Companies

 
• By Neena Brizmohun

The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.

EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
• By Eliza Slawther

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.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.