580 0 Kommentare The Alliance for Regenerative Medicine Publishes Position on Hospital Exemption of Advanced Therapy Medicinal Products in Europe - Seite 2

Create a publicly available registry of all sites using ATMP under HE and their therapeutic indications in all Member States.

Encourage Member States to make HE subject to the approval of an ethical committee review on a case-by-case basis.

Develop tutorials to educate the medical community and research institutions on requirements for ATMPs, clinical studies and marketing authorization.

Offer incentives at the EU and/or Member States level to stimulate academic/industry collaborations.

"ARM has taken an important leadership role in advocating for a consistent interpretation and implementation of HE among European Union Member States," said Eduardo Bravo, Managing Director and CEO of TiGenix, member of the ARM Executive Committee. "We believe that ARM's initiative for greater clarity on HE addresses the hurdle to patients' access to effective treatments that the current divergent implementation of HE across the EU poses. Important for companies in our sector, clearly, is market access, and the position proposes a way forward to ensure HE is not misused to circumvent the applicable legal instruments for the authorisation of safe and effective medicinal products in Europe."

ARM's official position on HE is available here.

"We are very pleased that a series of planned activities, published by the EMA on 2nd February 2017 to foster ATMP development and enable expanded patient access in the EU, includes support of more transparency in HE, as proposed in our position paper. We encourage the stakeholders involved in the elaboration of the EU plan seeking to optimize the current regulatory framework to consider the other recommendations proposed in ARM's position on HE," concludes Annie Hubert, ARM's director of European public policy.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine and advanced therapies worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.