Regulatory Alerts2014-02-24
Added · Updated
Instructions for Insurance against Civil Liability Arising from Conducting Pharmaceutical Studies for the year 2013
The Jordan Food and Drug Administration issued instructions requiring entities conducting pharmaceutical studies, including bioequivalence, bioavailability, and human intervention studies, to secure civil liability insurance from licensed companies in Jordan. These instructions establish minimum compensation limits for various types of harm, such as 17,000 Jordanian Dinars for death or total permanent disability and 15,000 Jordanian Dinars for medical treatment, and prohibit reducing these limits. The document also mandates that local insurance coverage for therapeutic studies must match or exceed the highest global coverage for the same study, and sets a maximum deductible of 2% of the claim value. These instructions, which repeal previous 2010 regulations, became effective 30 days after their publication on February 28, 2013.