Medicines for Europe and GPhA commit to supporting positive developments of the negotiations for TTIP

PRESS RELEASE

WASHINGTON, DC (Sept. 23, 2016) —

· Medicines for Europe and GPhA are committed to supporting positive developments of the negotiations for a TTIP and in particular the regulatory cooperation of pharmaceuticals therein.

· Improving patient access to safe and effective generic drugs can improve patients’ health, lower system costs and can contribute significantly to more competitive, efficient and sustainable pharmaceutical policies.

Medicines for Europe and GPhA (Generic Pharmaceutical Association) are committed to supporting positive developments of the negotiations for a TTIP agreement and in particular the single development of biosimilar and complex generic medicines and the regulatory cooperation on pharmaceuticals therein. The conclusion of a Mutual Recognition Agreement on Good Manufacturing Practices (GMP) inspections between the EU and US would strongly stimulate efficiency and help ensure the quality of medicines while removing unnecessary duplications for both the industry and regulators. A joint Medicines for Europe and GPhA delegation led by their top management and composed of member companies’ senior managers has made a round of meetings in Washington DC during last week on the negotiations for a Transatlantic Trade and Investment Partnership (TTIP). USTR, FDA, and several offices of Congress were amongst the visited US institutions.

Adrian van den Hoven, Medicines for Europe Director General, highlighted during this visit that: “We appreciate the efforts employed by the EMA and the European Commission and the FDA to further align on approval processes of generic and biosimilar medicines. This will speed up access to these medicines for patients in EU and the US, and allow the EU and US to play a leading role in international regulatory cooperation initiatives on pharmaceuticals”.

David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA, said: “Improving regulatory coordination can avoid unnecessary duplication of product development, regulatory review, and approval efforts; as well as help alleviate significant delays in getting safe, effective and more affordable medicines to patients. GPhA continues to support a joint regulatory strategy where generic drug guidances and guidelines are coordinated and adopted by both the E.U. and the U.S. regulatory authorities. For example, if generic drug manufacturers could follow a single development pathway it would expedite patient access and grow health system savings.”