Simplifying Global Compliance
A proposal moving through the EU Parliament to centralize data protection across member states would grant clinical trial participants the ability to demand that their trial data — including data shared between regulators and other entities — be effectively “erased.” Read More
Following months of intense negotiations, the European Commission and Canada last month reached a political agreement on key elements of a free trade deal that brings Canadian intellectual property protections more in line with those of the EU. Read More
Manufacturers of branded drugs will see their prices capped for the first time beginning Jan. 1, under a new pricing scheme adopted by the UK’s National Health Service. Read More
Britain’s brand drugmakers are poised to disclose payments and other honoraria they make to physicians, beginning in 2016. Read More
Sponsors can now begin voluntarily uploading summary results of clinical trials to the European Medicines Agency’s newly updated EudraCT database. Read More
The European Medicines Agency’s push to make more clinical study report (CSR) data available to the public will benefit public health, but it doesn’t go far enough, according to a new study. Read More
The European Medicines Agency took the wraps off its new safety monitoring program with a request that Takeda Oncology and Seattle Genetics develop a tougher risk-management plan for the lymphoma treatment Adcetris. Read More
When adding a pediatric indication to a drug product, drugmakers are advised to consider a range of different pharmaceutical forms and formulations that might be more suitable for children, a draft revision to European Commission guidelines on pediatric investigation plans says. Read More
The European Medicines Agency will let drugmakers seeking authorization for antibiotics that target multidrug-resistant infections use an abbreviated approval path, according to revised guidance. Read More
Use of the “multiple comparison procedure – modeling,” or MCP-Mod, approach to dose-response testing and estimation provides a “more solid basis” for Phase III dose selection, the European Medicines Agency says in a recently posted draft opinion on the methodology. Read More
Sponsors and sites should base potential adverse reaction profiles of drugs in clinical trials on previously observed events, rather than anticipated pharmacological properties, the Danish Health and Medicines Authority says. Read More
Beginning in 2014, Switzerland’s therapeutic product regulator will no longer be approving “generics,” and will instead only authorize known active pharmaceutical ingredients. Read More
After assessing its response to a recall in April, Health Canada is considering requiring drugmakers to notify the agency about emerging risks of marketed drugs before initiating recalls. Read More
The U.S. Food and Drug Administration and Poland’s Główny Inspektorat Farmaceutyczny have agreed to share the results of good manufacturing practice inspections, building on a practice increasingly embraced by regulators around the world. Read More
With its anticorruption crackdown on pharma in full gear, Chinese regulators renewed their attention on internet pharmacies, introducing new requirements aimed at disrupting domestic peddlers of substandard and counterfeit drugs. Read More
Chinese authorities reportedly are preparing to prosecute individual GlaxoSmithKline officials in China for bribery, rather than bring charges against GSK’s entire China division, according to sources with knowledge of the ongoing investigation. Read More
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