Regulatory Cooperation in TTIP

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Presentation transcript:

Regulatory Cooperation in TTIP Sergio Napolitano EGA Legal Affairs & Trade Director 2 July, Brussels

EGA Vision 2020

Regulatory Cooperation to Spur Trade & Investments Global markets but local policies and rules Reinforce regulatory cooperation to stimulate jobs & growth Reduce scientifically unjustified burdens / duplications / divergences Apply good regulatory practices

TTIP Chapter on Regulatory Cooperation Regulatory Compatibility: Early info on planned acts Planned stakeholders consultation Regulatory Cooperation Body Involvement of stakeholders, also sectoral International regulatory cooperation Joint approaches in Int’l fora Promote highest regulatory standards globally Need coherent EU trade policy

TTIP & Generic and Biosimilar Medicines Alignment on Biosimilar Medicines Results already tangible First Biosimilar approved in US 75% EU Biosimilar applications Alignment on Complex Generic Medicines Mutual Recognition of GMP Inspections

The Benefits: Patients – Industry – Regulators - Govts Removal of unethical duplication of unnecessary clinical trials Reduction of development costs for the industry Opportunity to invest potential savings into new medicines Faster & increased access to high quality generic & biosimilar medicines for patients More sustainability of healthcare systems Promotion of the highest standards globally Sharing of scientific knowledge between regulators More power to regulators: legal authorisation (not obligation) to use/share data and requirements when assessing medicines or inspecting sites Reduction of duplicative workload for industry and regulators More efficient use of resources Potential for global cooperation

Thank you ! Contacts: Sergio Napolitano sergio@egagenerics.com