The EU’s legislative revision proposals include stripping down the European Medicines Agency’s committee structure, abolishing the five-yearly marketing authorization renewal requirement, and doing away with the “sunset clause” that requires a product to be launched in at least one EU country within three years of approval.
Among the many wide-ranging proposals for the overhaul of the EU medicines legislation that are due to be published at the end of this month is a radical restructuring at the European Medicines Agency that will see the number of its scientific committees reduced from six to two.
The two committees that would remain are the Committee on Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk...
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.
