Public health experts tell committee that much work lies ahead in strengthening the regulatory systems of low-and middle-income countries, and recommend ways to bolster these systems and improve the quality of imports.
A public and private partnership program has worked well in outlining the expectations of regulators and boosting the quality of India's drug exports, while direct technical assistance to low- and middle-income countries in the Americas was found more effective at strengthening regulatory systems than were regional regulatory harmonization activities.
These were some of the findings shared at a Jan. 8-9 meeting in Washington of the newly formed Committee on...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
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.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
