Ref. Ares(2015)5636281 - 07/12/2015
Ref. Ares(2016)6036878 - 20/10/2016
Health Series 2015- Multi-stakeholder debate on regulatory convergence aspects of the
The Permanent Representation of Denmark to the European Union organised on 26/05/2015 a
Multi-stakeholder debate on regulatory convergence aspects of the TTIP with a focus on
The debate comprised:
A short status on the Pharma chapter in TTIP provided by USTR and European
Commission, DG TRADE
The perspectives from the regulators provided by US FDA and European
Commission (DG SANTE) and European Medicines Agency (EMA).
Industry reflections on the following topics: Mutual recognition of GMP/GCP
inspections, Harmonisation of paediatrics requirements (format, plan and
timelines), Scientific advise (joint/parallel) and Medicines pathways.
Short discussion on priorities and opportunities moving forward
COM provided a state of play of negotiations Round 9 that had taken place in April 2015.
The EU priorities are the ones as set in the publically available position paper (Good
manufacturing practices, biosimilars, generics, exchange of regulatory information
between regulators, paediatrics, etc). COM reiterated that regulators (SANTE and EMA
and US FDA) are at the negotiation table. A lot of work has taken place on GMP but
there is still considerable work to be done in 2015. Legal texts are not yet available nor
being discussed. COM expects to have concrete deliverables in certain areas and establish
the cooperation path in other areas. There is also the intention to continue commitment
on cooperation at international level in fora such as ICH as well as reinforcing exiting
bilateral EU-US cooperation.