The European Commission services and the European Medicines Agency, in collaboration with the authorities of the Member States, have initiated a number of initiatives to improve the regulatory environment for ATMPs so as to facilitate the development and authorisation of these products in the EU for the benefit of patients.
- Guidelines on good manufacturing practice for ATMPs expected by Q4 2017
- Initiation of dialogue with national competent authorities to address the interplay between the legislation on GMOs and medicines, expected by Q3 2018
- Revision of EMA procedures regarding the assessment of ATMPs, by Q4 2017
- New EMA scientific guidelines on ATMPs, including investigational ATMPs:
- Guideline on gene therapy, by Q4 2017
- Revision of the guideline on genetically modified cells for consultation as of Q1 2018
- Guidance on comparability by Q2 2019
- Continuous awareness and training sessions organised by the EMA
The EU is committed to support the development of these products and will keep monitoring developments in the field to ensure that the regulatory framework supports — and not hinders — the development of ATMPs.
It is expected that the implementation of the proposed actions will increase the opportunity for patients to be treated with novel therapies (through enrolment in clinical trials and authorisation of new products). Moreover, an improved regulatory framework will also contribute to promoting innovation, investments and competitiveness of the EU biotechnology sector, whilst striving to ensure patient access.