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SOCMA's Bulk Pharmaceuticals Task Force Welcomes Waiver for U.S. API Imports to Europe

Exemption Ensures Continued Supply of Safe Drugs

FOR IMMEDIATE RELEASE

Contact:
PR & Communications Department
(202) 721-4100
pr@socma.com

Washington, DCThe Bulk Pharmaceuticals Task Force (BPTF) today hailed an announcement from European officials granting U.S. drug makers an exemption from new export requirements, thereby ensuring a continued supply of safe drugs into the EU from the U.S.

“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.

BPTF supports negotiations between the U.S. and the EU to eliminate trade barriers, to promote greater global harmonization of current Good Manufacturing Practices (GMP) 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.

BPTF is an industry trade group for manufacturers of active pharmaceutical ingredients, with the primary objective of seeking clarification of current regulatory requirements. BPTF is an affiliate of the Society of Chemical Manufacturers and Affiliates, a trade group representing the specialty chemical industry.

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About BPTF

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients.

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