that even as the global push for harmonisation continues, companies cannot afford to lose sight of local requirements. There remain critical differences in drug and device regulations between ...

Uncertainty adding new regulatory drift. Amid the increased unpredictability of economic policies affecting the business ...

In this article we look at global regulatory efforts to re-position market structures and ensure effective compliance ...

and an increase in the number of new Chinese drugs approved by the USFDA. India’s lax regulatory requirements, on the other hand, have perpetuated patent infringement and combined with ...

CEOs from European drugmakers Sanofi and Novartis have inked a letter in The Financial Times urging the European Union to set ...

Government health officials told source they were exploring an international reference pricing policy U.S. pays nearly three times more than other developed countries for drugs The policy is more ...

Accelerated drug development and approval pathways, designed to expedite the delivery of essential medicines for patients with serious and rare diseases, have been successfully implemented in the ...

Is your organization simply ticking compliance boxes, or are you genuinely fostering patient trust and safety in the "era of ...

There have been growing calls for harmonization of real world evidence (RWE ... the use of robust studies conducted outside the CMS-eligible population (including international studies), the guidance ...

sometimes referred to as international reference pricing, according to government records. The U.S. pays the most for drugs in the world, often nearly three times that of other developed nations.