COSTA RICA REFORMS DRUG REGISTRATION RULES

Costa Rica has issued additional rules for drug registration, which are expected to boost local conditions for foreign firms. The new regulation will require proof of bioequivalence and novelty for imported drug products. Notably, similar rules in Mexico have recently denoted a positive step toward forcing copies off the market.

Drug marketers will be obliged to re-register their products with the new rules in mind, helping to meet intellectual property obligations under CAFTA. Executive Decree 32470-S, as the new law is known, is positive for research-based drug firms. Costa Rica is an important clinical trials outsourcing base, boasting the largest private clinical trials facility in the region.