API manufacturers in the U.S. and the EU say the ICH Q11 guidance lacks specific direction on when chemicals become starting materials, and as a result there are differing interpretations on designation among regulators. A member of ICH Q11 group advised industry to focus on supply chain, not steps.
The International Conference on Harmonization’s Q11 guideline lacks specific direction on defining starting materials and as a result regulators are interpreting it in different ways, say API manufacturers in the U.S. and the European Union.
Efforts are currently under way among different groups in Europe to develop clearer guidance for starting materials.
MSD is gearing up to demonstrate the value of its pulmonary arterial hypertension drug, after England’s health technology assessment institute provisionally said the product was not cost-effective. Meanwhile, the company told the Pink Sheet about Winrevair’s reimbursement status across Europe.
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
