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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
The EMA said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Read More
The World Trade Organization ratified an amendment to the Trade Related Aspects of Intellectual Property Rights (TRIP) agreement, authorizing developing countries with limited production capacity to import generics when facing a drug shortage. Read More
Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to quality management issues. Read More
Aspen Pharma and Deco Pharma, the company’s distributor, face disciplinary proceedings from Spain’s antitrust authority for allegedly limiting the distribution and hiking the prices of drugs. Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Read More