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The Chinese FDA is proposing to relax restrictions on imported drugs by no longer requiring that foreign drugs be approved abroad, or be in late-stage clinical trials, before an international multi-center trial can be started in China to seek an approval. Read More
An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More
The EMA is recommending the European Commission suspend sales of more than 300 generic drug formulations approved using flawed bioequivalence studies conducted at two Micro Therapeutic Research Labs’ facilities in India. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices.
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The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009. Read More
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release three documents as part of its transparency efforts. Read More
The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement. 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 a European Commission report. Read More
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging from inadequate quality management to deceptive drug promotion. Read More
Despite the Senate defeat of a measure allowing drug importation earlier this year, House and Senate Democrats are trying again: they’ve introduced new legislation that would allow imports of prescription drugs from Canada. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis, which stemmed from Chinese manufacturing facilities. Read More