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The Therapeutic Goods Administration has adopted European Commission guidance on good pharmacovigilance practices for vaccines. The guideline includes recommendations on reporting reduced effectiveness or failure of vaccines and how to implement a recall or halt the distribution of problem batches. Read More
Drugmakers seeking to list their products on the Australian Register of Therapeutic Goods should include unfavorable nonclinical study reports in their applications, updated guidance says. Read More
The European Medicines Agency now requires centralized review of periodic safety update reports for active pharmaceutical substances found only in medicines authorized at the country level. Read More
The UK’s health cost watchdog says it is not ready to change the way it appraises medicines and other technologies, but acknowledges that further consideration is needed of how new treatments are developed, evaluated and supported for coverage. Read More
India’s drug pricing control bureau has abruptly withdrawn a guideline for setting prices for many branded-generic drugs, a move that could bolster companies’ case in a lawsuit against the government’s pricing policies. Read More
The Indian government last month warned manufacturers and importers of certain essential drugs that they will face legal action if they don’t submit monthly production and sales figures and other compliance documents, as officials try to address the scarcity of products in many parts of the country. Read More
Indian authorities are reminding clinical investigators that trial applications must include information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product and existing options. Read More
British drugmaker GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
European drugmakers praised a plan to move medicines regulation from a tripartite of directorates led by health and consumers to a single directorate, industry, saying it will reduce organizational silos. Read More
Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a final guideline adopted by the European Medicines Agency. Read More
Sponsors of investigational drugs could see some relief from burdensome adverse event reporting requirements in the EU’s 2010 good pharmacovigilance practice law, thanks to a revised guideline issued last month by the European Medicines Agency. Read More