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China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last updated in 2009. Read More
The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009. Read More
The European Medicines Agency saw a 28 percent increase in the number of applications for orphan product designations in 2016 compared to the previous year. Read More
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that 10 percent of them are substandard. Read More
China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical marketing. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to an European Commission report. Read More