Dear Colleagues,
On 20th October 2017, the
EC's Directorate-General for Health and Food Safety (DG SANTE) and the EMA published a
joint action plan to foster the development of advanced therapy medicinal products (ATMPs) with the aim of streamlining procedures and addressing specific requirements of ATMP developers.
Within the EU, ATMPs are governed by Regulation 1394/2007 ("ATMP Regulation").
Marketing Authorisation Applications are evaluated via the Centralised Procedure and the process is led by the Committee for Advanced Therapies ("CAT") who prepares a draft opinion before the CHMP adopts a final opinion and an authorisation issued. Nine products have been approved this way since the ATMP Regulation came into force in 2009.
At present, Clinical Trial Applications for ATMPs are considered at a national level and there are many discrepancies between the requirements of different Member States. One of the aims of the joint action plan is to provide greater guidance to Member States when evaluating Clinical Trials involving ATMPs.
ATMPs fall under four main categories:
- gene therapy medicinal products
- somatic cell therapy medicinal products
- tissue engineered medicinal products and
- combined ATMPs
They are a novel and ground-breaking approach of particular importance in cases of severe, untreatable or chronic diseases for which conventional therapies are ineffective or inadequate.
The plan referenced above contains 19 actions in different key areas. It aims to facilitate greater harmonisation between Member states in regard to regulation of ATMPs, provide greater transparency and information sharing and to improve patient access to ATMP treatments.
Examples of some of the actions included in the joint plan are as follow:
- Introduction of an EC Guideline on GMP for ATMPs. The aim of this Guideline would be to reduce administrative burden and adapt the manufacturing requirements to the specific characteristics of ATMPs. Subsequently to the adoption of the Guideline, EMA will organise specific training to inspectors with a view to achieve more harmonisation. The aim is to introduce this guideline Q4 2017. However, this timeline is indicative and subjective to change.
- Initiation of a dialogue with national competent authorities to address the interplay between the GMO and the medicines legislation. The aim is to reduce discrepancies across the EU regarding the application of GMO rules (Directives on deliberate release or contained use) to ATMPs containing or consisting of GMOs. At present, this is highly variable between member states. Issues relevant for both clinical trials and marketing authorisation will be addressed. The aim is to commence this process Q3 2018.
- To introduce an EMA Guideline on Investigational ATMPs. The aim is to have a draft guideline for consultation by Q4 2018. The guideline would assist in eliminating discrepancies across the EU regarding the requirements for ATMPs in the clinical trial phase. The Guideline would not change the competence of Member States to approve clinical trials but it would help create common standards for the assessment of these novel products.
- GCP for ATMPs. Due date: 2019
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Karen Real
Director
Real Regulatory Ltd
London
United Kingdom
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