Regulatory Aspects of Advanced Therapy Medicinal Products in the EU

    /Adriaan  /Fruijtierspeaker of compliance global
    Speaker: Adriaan Fruijtier
    Duration: 60 Minutes
    Product Code: 700190
    Level: Intermediate
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overview

Advanced physical therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration. 

The ATMP Regulation 1394/2007 aims to facilitate the patient access to these products and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients. ATMPs are pharmaceuticals with high complexity linked to their development, manufacturing, or administration process.

The Regulation addresses the following points:

  • Definition: ATMPs are gene therapy for cancer, adult cell stem therapy, or tissue-engineered medicinal products
  • For Marketing Authorisations, the centralised procedure is mandatory

The exemptions to the ATMP Regulation are discussed in this webinar, in particular the hospital exemption. The hospital exemption is limited to non-routine products, custom-made for individual patients. Manufacture of ATMPs under hospital exemption has to be authorised by the appropriate member state to ensure appropriate quality. There are no efficacy criteria mentioned.

why should you attend

Advanced-therapy medicinal products (ATMPs) are medicines for human use that are based on gene therapy, somatic-cell therapy or tissue engineering. They offer ground-breaking new opportunities for the treatment of disease and injury.

As this is a new area, early contacts with the regulatory authorities are particularly important. There are a number of procedures available during the development of these products. These procedures are explained in this webinar.

Companies can apply to the European Medicines Agency to determine whether a medicine they are developing is an advanced-therapy medicinal product (ATMP). The procedure allows them to receive certification that a medicine, based on genes, cells or tissues, meets the scientific criteria that define ATMPs.

The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced-therapy medicinal products (ATMPs) under development by micro, small and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development.

The certification procedure involves the scientific evaluation of quality data and, when available, non-clinical data that SMEs have generated at any stage of the ATMP development process. It aims to identify any potential issues early on, so that these can be addressed prior to the submission of a marketing authorisation application.

After the assessment, the CAT may recommend issuing a certification confirming the extent to which the available data comply with the standards that apply for evaluating a marketing authorisation application. Following the CAT recommendation, the Agency issues a certification.

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Areas Covered

The Webinar will start with an introduction, an overview of the Regulation. 

The Regulation defines the pre- and post-authorization requirements: Good clinical practice, product follow-up on efficacy and safety, risk management plan, and traceability.

The Regulation also provides incentives for applicants by offering scientific advice at various development steps at substantially reduced fees, mainly to small- and medium-sized enterprises and hospitals.

Two exemptions are foreseen to the ATMP Regulation:

  • The first exemption relates to a transition period which allowed existing products to evolve toward ATMP-compliance. Products, which were legally on the Community market on December 30, 2008 (when the Regulation became applicable), should have been compliant to the Regulation requirements no later than December 30, 2012 and should have been withdrawn from the market if no centralized MA application has been submitted and granted
  • The second exemption to the Regulation is the hospital exemption rule. The hospital exemption allows hospitals and medical practitioners to provide ATMP-classified products to patients, e.g., in case of high unmet medical need because there is no authorised ATMP alternative available. Examples are some tumour vaccines, made by hospitals for treating cancer patients having no treatment alternatives 
  • An overview of the composition and role of the Committee for Advanced Therapies (CAT) will be provided. The main responsibilities are:
  • The evaluation of MA applications by providing opinions to the Committee for Medicinal Products for Human Use (CHMP); the CHMP may adopt or refuse the CAT opinion
  • The optional scientific certification of quality and non-clinical data of a proposed ATMP-compound in development
  • The optional scientific recommendation on ATMP-classification, prior to their clinical development

As stem cells pose unique risks, the EMA position on the use of stem cells is discussed. Also the relevant guidelines are addressed in this Webinar.

The Tissues and Cells Directive (2004/23/EC), which applies to donation, procurement and testing of human tissues and cells is described.

The role of the national innovation offices will also be examined.

Learning Objectives

  • What ATMPs are
  • Which all procedures the EMA offers
  • Where to obtain help and advice

WHO WILL BENEFIT

  • Regulatory Affairs Personnel
  • Sponsor Senior management
  • Project Managers
  • Clinical Trial Heads
  • Medical writers
  • CRAs and CRCs
  • QA /  Compliance personnel
  • Investigators
  • Clinical Research Scientists
  • QA / QC Auditors and Staff
  • Consultants

SPEAKER

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004, he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked for four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997. Before 1996, he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.

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