Archive for March 2016

The European Medicines Agency and the European Commission published new track-and-trace safety requirements Feb. 10 affecting all drugmakers doing business in EU countries. Source: International Pharmaceutical Regulatory Monitor

The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Source: International Pharmaceutical Regulatory Monitor

Drugmakers submitting anonymized clinical data in applications to the EMA must keep up on technology advances that could put that data at risk for re-identification. Source: International Pharmaceutical Regulatory Monitor

An NHS England spokesperson confirmed Feb. 18 that the agency will investigate whether more than 130 NHS staff involved in assessing drugs were also paid as consultants by drugmakers. Source: International Pharmaceutical Regulatory Monitor

With 12 nations signing off on the Trans-Pacific Partnership, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Source: International Pharmaceutical Regulatory Monitor

Six new drugs have scored wins at the European Medicines Agency, scooping up recommendations for marketing authorization from the Committee for Medicinal Products for Human Use. Source: International Pharmaceutical Regulatory Monitor

Generics giant Mylan N.V. has struck a tentative deal to purchase Swedish drugmaker Meda AB for $7.2 billion in cash and stock. Source: International Pharmaceutical Regulatory Monitor

Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active ingredients of Lovenox and heparin. Source: International Pharmaceutical Regulatory Monitor

An FDA advisory committee gave South Korea’s Celltrion’s biosimilar candidate for Remicade a strong show of support Feb. 9, backing its approval for six indications. Source: International Pharmaceutical Regulatory Monitor

The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans to focus on over a product’s lifecycle. Source: International Pharmaceutical Regulatory Monitor