New regulations in the European Union, coming into action early next year, make it imperative that drugs for use in humans, including those destined for clinical trials, must be manufactured in a EU-certified Good Manufacturing Practice (GMP) facility.
With the deadline for the legislation fast-approaching, it is remarkable that just one US company, clinical supply manufacturer Formatech , has so far been certified by an EU recognised authority.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has certified the company for the manufacture and associated controls of aseptically processed sterile dosage (liquids and lyophilised) units for clinical trial purposes.
"The EU GMP Compliance Certificate from MHRA is an important milestone for Formatech as the new European regulations … will require that all clinical products must be manufactured in a EU GMP certified facility," said Ben Isaacs, the company's president.
The Directive (2003/94/EC) was agreed in October and must be implemented by all EU member states no later than 30 April, according to the Commission. The earlier Directive covering this issue (91/356/EEC) has been repealed.