EMEA, Health Canada link up
This article was originally published in The Tan Sheet
The health authorities will share legislation under development, draft guidance documents and non-public safety and efficacy data on regulated products, according to an implementation plan for regulatory cooperation published April 2. The European Medicines Agency and Health Canada also call for routine communication about good manufacturing practice inspections performed outside the respective territories and will allow access to each other's GMP database information. The cooperation plan says the partnership will seek to include U.S. FDA in joint activities "to minimize duplication of effort." EMEA, FDA and Australia's Therapeutic Goods Administration have launched a pilot to share GMP inspection information (1"The Tan Sheet" Jan. 19, 2009, p. 9)
You may also be interested in...
FDA and its counterparts in the European Union and Australia have divided responsibilities for inspecting specific active pharmaceutical ingredient facilities in third-country locations in the next 18 months as part of a pilot to monitor more sites
With makeup and lipstick sales down globally at a time of wide mask use, Shiseido is focused on skin health, planning launches to address sensitive skin needs and heightened demand for cleansing and protection effects. In August, the firm projected a 16% decline in net sales for full-year fiscal 2020.
The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.