The European Medicines Agency announced a three-year, 16-point action plan to boost small- and medium-sized pharmaceutical companies. Source: International Pharmaceutical Regulatory Monitor
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be…
The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into the development of new treatments and alternatives — including support for small- and medium-sized…
The European Commission has opened a formal antitrust investigation into South African manufacturer Aspen Pharma over concerns of excessive pricing of five cancer medicines. Source: International Pharmaceutical Regulatory Monitor
The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual…
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and…
Following the FDA’s addition of a Chinese API manufacturer to an import alert early last month, the World Health Organization was left without a prequalified source for the birth control…
The European Medicines Agency announced a new plan for closer collaboration between regulatory bodies and academia. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Source: International Pharmaceutical Regulatory Monitor
The European Medicines Agency plans to clarify its role regarding drugs manufactured in the EU solely for the export market. Source: International Pharmaceutical Regulatory Monitor