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The board of directors of Brazil’s Anvisa has suspended the deadline for companies to submit data for a new drug tracking system and is repealing the system’s implementing legislation. Read More
Some of the world’s poorest nations have been granted an extended exemption from enforcing pharmaceutical patent protections by a World Trade Organization body overseeing intellectual property rights. Read More
To beef up scrutiny of drugs, India’s health ministry has proposed a roughly U.S. $277 million plan to overhaul the Central Drugs Standard Control Organization — by strengthening the inspections framework, establishing new national testing laboratories and firming up databases of products and clinical trials. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
The European Commission released new guidelines clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Starting next June, drugmakers must use a new centralized database to file product safety update reports, the European Medicines Agency says. Read More
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More