• 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.

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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 EU and the US regulatory authorities. For example, if generic drug manufacturers could follow a single development pathway it would expedite patient access and grow health system savings.”

About Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com
Andrea Bedorin abedorin@medicinesforeurope.com

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on Twitter: @gpha.

GPhA Communications:
Steve Arnoff sarnoff@gphaonline.org