EMA and European Commission to Support Development of Advanced Therapies

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The European Medicines Agency (EMA) and European Commission published a joint action plan on October 2017 further the development of new cell, gene therapies, and advanced therapy medicinal products (ATMPs).

The plan features the release of several new and revised guidelines comes as on the international level, a regular forum for dialogue has been established to share experiences on advanced therapies between EMA, the US Food and Drug Administration, Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency. Out of nine approved drugs, four have been withdrawn from the market.

For instance, UniQure’s Glybera, the first gene therapy authorized in Europe in 2012, was later withdrawn from the market. Similarly, Dendreon’s Provenge and TiGenix’s tissue-engineered product ChondroCelect, approved in 2009, were also withdrawn. Vericel Denmark’s Maci in 2013 was suspended at the recommendation of CHMP. Other ATMPs present in the market and include German company Co.Don AG’s Spherox, approved in 2017, MolMed Spa’s Zalmoxis, approved in 2016, as well as Chiesi Farmaceutici’s Holoclar, GlaxoSmithKline’s Strimvelis, and Amgen’s Imlygic.

According to the EMA, advanced therapies are used to designate gene therapies, somatic cell therapies, and tissue engineered products governed by Regulation 1394/2007 on advanced therapy medicinal products also known as the ATMP Regulation. The evaluation of ATMPs is led by EMA’s Committee for Advanced Therapies, which offers a draft opinion before EMA’s Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion and an authorization can be granted by the Commission.

According to Advanced Therapy Medicinal Products Market report published by Coherent Market Insights,ATMPs are innovative therapies that comprises cell therapy, gene therapy, and tissue engineered products. Cell therapy products include cellular immunotherapies and autologous and allogeneic cells for certain therapeutic indications including adult and embryonic stem cells.EMA suggested its procedures regarding the assessment of ATMPs: “To reduce administrative burden, avoid overlaps between the tasks of the various committees involved, and address the specific needs of ATMP developers.” By the end of 2018, EMA is working on releasing a draft guideline for consultation on investigational ATMPs to “create common standards for the assessment of these novel products” and to “avoid discrepancies across the EU regarding the requirements for ATMPs in the clinical trial phase.” In addition, in Q2 of 2018, there will be a revision of EMA’s Guideline on Safety and Efficacy and Risk Management Plans for ATMPs to reduce administrative burden in the post-marketing phase.


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