Hong Kong is taking incremental steps to move towards a system where it can evaluate and approve new drugs more quickly and efficiently on its own. The moves include preparations for a new Hong Kong Centre for Medical Products Regulation.
As part of ongoing efforts to strengthen its drug evaluation capacity, Hong Kong has launched a new streamlined mechanism, called “1+”, to speed up the registration of pharmaceutical products containing new chemical or biological entities for life-threatening or severely-debilitating diseases.
Hong Kong currently relies on prior approvals granted by regulators in 36 reference countries to enable local drug registrations, but...
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Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
