The EMA said 30 drugs across four therapeutic classes have received conditional marketing authorization in the EU since the expedited approval pathway became available a decade ago. Source: International Pharmaceutical…

Italian regulatory authorities have ordered a ban on drug substances and bulk products manufactured by Antibióticos Do Brasil after an inspection revealed several GMP deficiencies, ranging from data integrity to…

Aspen Pharma and Deco Pharma, the company’s distributor, face disciplinary proceedings from Spain’s antitrust authority for allegedly limiting the distribution and hiking the prices of drugs. Source: International Pharmaceutical Regulatory…

Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Source: International Pharmaceutical Regulatory Monitor

The International Council on Harmonization is proposing to expand guidance concerning data quality, medication errors and product issues by developing a companion document that would include a Q&A section and…

Sponsors pursuing approvals for new drugs with any potential for abuse should expect to perform additional assessments. Source: International Pharmaceutical Regulatory Monitor

The FDA finalized guidance on the GMP requirements for combination products, adding scenarios to clarify how manufacturers can comply with requirements. Source: International Pharmaceutical Regulatory Monitor