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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
A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program. Read More
Europe’s biotech industry is pressing regulators to update guidance on labeling of biosimilars to include information on both the reference product and the biosimilar. The current practice of assigning a generic label is insufficient due to the products’ unique scientific and regulatory status, companies say. Read More
The Canadian government is ratcheting up scrutiny of patent litigation settlements between brand and generic drugmakers in attempt to prevent antitrust deals that delay generic competition. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More
The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. Read More