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

2. EGA Vision 2020

3. 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

4. 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

5. 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

6. 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

7. Thank you !
Contacts:
Sergio Napolitano