BRUSSELS, Belgium and WASHINGTON, D.C. – March 16, 2017 – The Alliance for Regenerative Medicine (ARM), the international advocacy organisation representing the cell and gene therapy and broader regenerative medicine sector, has taken note of the Letter from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to the European Commission stating their opposition, for public health reasons, to the publication of the Guidelines on Good Manufacturing Practice (GMP) for Advanced Therapy Medicinal Products (ATMPs) as a stand-alone document. In line with PIC/S, ARM asks the European Commission to reconsider its position and to seek agreement with PIC/S and the EMA Inspectors Working Group before finalisation of the guidelines.
The PIC/S Committee, which comprises representatives of PIC/S’ 49 Participating Authorities as well as representatives from Partner Organisations such as EMA, EDQM and WHO, have released a letter dated 24 February 2017 to the European Commission in which they state that the guideline could have a negative impact on public health and the safety of patients. The PIC/S Committee considers that the publication of the proposed Guideline will lower the GMP requirements for ATMPs thereby exposing patients to increased risks. The letter further comments that the PIC/S Participating Authorities are disappointed by the lack of consultation on the decision by the European Commission to enact the Guideline as a stand-alone document. They raise serious concerns over the divergence of the EU and PIC/S GMP Guides, which have been developed and aligned since 1989.
“An internationally non-harmonised approach to the implementation of GMP for ATMP may act to remove the potential for the use by developers of the long-standing mutual recognition agreements such as between the EU, Canada, Switzerland, Israel, Japan, Australia and New Zealand. Although ATMPs are currently out of scope of the recently EU-US agreement on mutual recognition of inspections of medicines manufacturers, it would be hoped that cooperative working could lay the foundation for their future inclusion”, says Jacqueline Barry, Chief Clinical Officer, Cell & Gene Therapy Catapult, and Chair of ARM’s European Regulatory Affairs Committee.
“ARM, like the majority of other respondents to the 2015 and 2016 consultations on the ATMP GMP guideline, consistently advocated for an integration of the GMP for ATMPs as an annex to the EudraLex Volume 4 of the Rules Governing Medicinal Products in the European Union” states Annie Hubert, ARM’s Director of European Public Policy. “Our members oppose the approach to publish the guide as a stand-alone document because they believe this could lead to a disparity in quality standards and will create unnecessary difficulties for the Competent Authorities at the time of inspection as well as for companies with ATMP and non-ATMP product portfolios”.
Consequently, ARM urges the European Commission to reconsider the release of this guideline as a stand-alone document and recommends instead that the guidance is incorporated in a separate Annex in the EU GMP guide and developed in close collaboration with the EMA Inspectors Working Group and PIC/S.
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 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. Prior to the formation of ARM in 2009, there was no advocacy organization specifically representing the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. 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 www.alliancerm.org.
Annie Hubert | Director, European Public Policy | +32 474 26 75 65 | email@example.com