International Pharmaceutical Regulatory Monitor

The European Medicines Agency (EMA) faces an EU fraud investigation amid questions about the robustness of the agency’s conflict-of-interest rules and pharmacovigilance program.

A drug regulatory reform bill approved last month by the French National Assembly calls for a $207 million increase in contributions by drug companies to finance continuing education for physicians.

In another harsh signal on anti-competitive practices, the European Commission is investigating whether Johnson & Johnson (J&J) and Sandoz conspired to delay generic versions of the painkiller fentanyl in the Netherlands.

India plans to drop price controls on specified bulk drugs, instead opting to regulate only the prices of formulations of finished medicines, according to a draft national policy released late last month by the Department of Pharmaceuticals (DOP).

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month released its blueprint for consolidating the 1968 Medicines Act and secondary legislation.

Sponsors seeking to import drugs into Canada for clinical trials must provide Health Canada with a “No Objection Letter” to facilitate shipment and demonstrate regulatory compliance, according to a Nov. 7 draft guidance on clinical trial applications (CTAs).

The European Medicines Agency (EMA) wants to update its guideline on biosimilar drugs to reflect the growing complexity of biosimilar products and unique issues concerning their development, according to an EMA concept paper.

To register biological medicines in Argentina, manufacturers must have a pharmacovigilance expert in that country to report suspected or real adverse events, the National Medicines, Foods and Medical Technology Administration (ANMAT) says.

The U.S., Europe and Australia conducted roughly 250 good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) facilities on a master list compiled as part of a two-year collaborative inspections pilot, according to a final report.

The European Commission (EC) adopted a revised proposal clarifying the kinds of information that drugmakers can provide the public on prescription-only drugs. Includes the full text of EC Proposal on Patient Information on Rx Drugs.

Drugmakers need to prioritize risks to data integrity in manufacturing and validate and monitor computer systems to ensure they perform as intended, a quality management expert says.

The European Medicines Agency (EMA) is seeking stakeholder input on the development of toxicological guidance for use in identifying the level of risk associated with making different drug products using shared facilities. Includes the full text of EMA Concept Paper on Multi-Drug Facilities.

The U.S. Food and Drug Administration (FDA) is developing guidances that will define expedited pathways to speed development and approval of promising drugs for diseases that present unmet medical needs and for patients most likely to benefit from specific therapies, FDA Commissioner Margaret Hamburg says.

Clinical trial sponsors testing cancer vaccines should carefully consider patient population heterogeneity, a U.S. Food and Drug Administration (FDA) final guidance states.

Sponsors can develop harmonized individual case safety reports (ICSRs) that are universally understood and electronically transmissible to anyone needing them under a U.S. Food and Drug Administration (FDA) guidance adopted from the International Conference on Harmonisation (ICH).