In April 2016, the Transatlantic Trade and Investment Partnership „TTIP” , negotiated between the EU and the US, was taken one step further. The 13th round of negotiations took place in New York. The European Commission has now published a detailed report on the three negotiated areas market access, regulatory cooperation and rules. Furthermore the EU has released a 7-page EU-proposal for an annex on medicinal products containing details for the pharmaceutical sector.
In the area of GMP the EU-proposal covers three main areas: inspections, approval and regulatory innovation. Overall it can be said that regulators within the US and the EU should be enabled to work together more closely to ensure that medicines are safe, effective and available. As both parties are members of the ICH, they shall implement all ICH and VICH guidelines. If they develop or implement requirements, guidelines and procedures which are not harmonized by ICH, scientific or technical guidelines developed by the WHO, the OECD or the PIC/S should be considered.
Further targets are:
- It is intended that a scientific dialogue and exchange of information shall cover research, development and assessment of different types of medicinal products, including innovative products, generics, biosimilars and medicinal products of major public health interest or that address unmet medical needs, including products eligible for accelerated assessment or related schemes.
- Regarding GMP-inspections the EU-Annex says “that a Party shall accept a certificate of Good Manufacturing Practice (GMP) compliance issued by a competent authority of the other Party, as demonstrating that the manufacturing facility that is covered by the certificate and located in the territory of that Party complies with GMP”. The terms and conditions for a certificate of GMP compliance for a manufacturing facility located outside the territory (third countries), will be set out in an additional annex.
- The competent authorities shall be allowed to exchange relevant regulatory information, including confidential and trade secret information related to the authorization and supervision of medicinal products. This may include e. g. draft guidances, position papers, reports on GMP and GCP inspections, information on GMP non-compliance, recalls, data integrity and risk of shortages of medicinal products. Provisions to protect the exchange of confidential information or trade secrets shall be put in place.
- A Working Group for the regulatory cooperation on medicinal products shall be established. The EU will be represented by the European Commission with the support of the EMA. The US will be represented by the FDA and the US Departement of Agriculture. The Working Group shall then establish a joint regulatory cooperation work plan.
EC: Report on 13th round of negotiations EU/US
EC: EU proposal for an annex on medicinal products