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News about GMP/cGMP

2017-07-11

Swissmedic: Implementing of the Therapeutic Products Act Packet IV

As a result of the revised Swiss Therapeutic Products Act of March 2016, the relevant ordinances also need to be comprehensively adjusted. This affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic and will last until October 2017.

 

Individual provisions (national recommendations on off-label dosages of paediatric medicinal products, or definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms will enter into force ahead of schedule at the beginning of 2018. The Federal Council is conducting a consultation procedure for most of the implementing provisions (Therapeutic Products Ordinance Package IV), which are scheduled to apply from 2019.

The Ordinary Revision of the Therapeutic Products Act (Stage 2) is part of the Confederation's master plan for strengthening biomedical research and technology and aims at

  • Facilitating the access to medicines through simplyfing the authorisation of certain medicinal product categories
  • Improving drug safety by adapting to international developments
  • Promoting medicines for children by introducing a incentive system for the pharmaceutical industry. This could help to promote the development of paediatric medicines.
  • Increasing of transparency, e.g. through the publication of additional information on medicinal products submitted for assessment or their marketing authorisation holders.
Source:

Swissmedic: News

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