The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force hailed an announcement from European officials granting U.S. drug makers an exemption from new export requirements.
The ruling ensures a continued supply of safe drugs into the EU from the U.S., SOCMA said in a statement
“We are pleased that U.S. drug manufacturers will not be required to provide written confirmation of quality for the exportation of active pharmaceutical ingredients into the EU,” said John DiLoreto, Executive Director of BPTF.
For countries that did not receive a waiver, the requirement for written confirmation goes into effect on July 2.
The Bulk Pharmaceuticals Task Force, an affiliate of SOCMA, supports negotiations between the U.S. and the EU to eliminate trade barriers, to promote greater global harmonization of current good manufacturing practices requirements and to improve the safety of drugs throughout the supply chain.
DiLoreto praised the Food and Drug Administration in putting effort towards working with foreign regulatory authorities.
“We hope FDA and EU officials will continue to attain the maximum achievable level of information sharing and greater harmonization on implementation of GMPs throughout the drug supply chain,” DiLoreto added.
For more information, visit www.socma.com.