Advocacy group criticises EC's plan for stand-alone cell & gene therapy GMP doc
In June, the European Commission (EC) called on stakeholders to comment on proposed guidelines on Good Manufacturing Practice (GMP) for ATMPs, encompassing medicines based on genes, cells or tissues.
The consultation period closed this week, but the Alliance for Regenerative Medicine (ARM) has released its comments on the proposed guidelines. While the group commends the efforts to provide specific guidance for ATMP manufacturers, it questions the need to create a stand-alone document.
“Advanced Therapies are different from traditional medicines or other biotechnology products such as recombinant proteins or monoclonal antibodies,” the industry advocacy group told Biopharma-Reporter.
“The specific characteristics of ATMPs are taken into account in the regulatory framework - eg Regulation 1394/2007 specifically dedicated to advanced therapies - but they also need to be recognised and addressed in GMP guidance.”
As such, the group – which counts nearly all biopharma companies developing cell and gene therapies among its members, along with equipment and services firm – believes “the creation of a stand-alone document may lead to disparities in GMP standards, creating unnecessary confusion for companies with ATMP and non-ATMP product portfolios,” as well as creating challenges for regulatory agencies during facility inspections.
“In addition, ARM is concerned that for those organisations developing ATMPs that may be less experienced in GMP and licensing requirements, the existence and adherence to two separate GMP reference documents could lead to disparate practices, resulting in different quality standards.”
Instead, the group believes designing the document as an annex in Eudralex Volume 4 of the ‘Rules Governing Medicinal Products in the European Union’ would be more beneficial.
Therefore ATMP product manufacturing guidelines would be similar to blood derived products and investigational medicinal products, covered in separate annexes (14 and 13, respectively) within the EC’s rules for governing medicinal products.
“This would enable the text to focus only on the GMP elements that need specific adaptations for ATMPs taking into account the particularities of the individual product types (TEP, GTMP), with clear cross-referencing to other requirements that are common to all medicinal products for human use. Subsequent revisions will also be much simplified as these would be limited to changes required due to progress in the field of ATMPs.”
The final guidance is expected to be released next year, and the full history of the EC’s initiative can be found here.