The European Commission finally issued GMP standards for advanced therapeutic pharmaceutical products

Source: on November 27, 2017, after long consultation with stakeholders on how to best set GMP standards for advanced treatment products, the European Commission finalized the long-awaited GMP guidelines on innovative cell, gene and tissue therapy, also known as advanced treatment pharmaceutical products (ATMP) The industry is now actively working with EU inspectors and authorities to reach a consensus on the risk-based principles outlined in the final document Even after two rounds of targeted consultations in 2015 and 2016, the Committee and various stakeholders have not yet reached an agreement on the form of the final document, so the publication of the final guide has been put on hold for one year Although the Commission proposes to publish the guidelines as a separate document, some stakeholders would like to publish them as an appendix to the current EU GMP guidelines for generic drugs (eudralex Vol 4) The governing body of the international pharmaceutical inspection agreement (PIC / s) is one of the most vehement opponents of the committee's proposal After further discussions with stakeholders earlier this year, the committee finally decided that the final GMP guidelines for ATMP should be a self-contained document to be issued as part IV of Volume 4 of eudralex Barbara freischem, executive director of the European Organization of Biopharmaceutical Enterprises (EBE), which represents Biopharmaceutical Enterprises of all sizes, said the orientation of the guidelines highlighted its close relationship with the EU's general principles of GMP EBE is also a professional group of the European Pharmaceutical Industry Association (EFPIA) Freischem, speaking on behalf of EBE and EFPIA, welcomed the adoption of the long-awaited final GMP guidelines and said "this is an important step to keep Europe competitive in providing advanced therapeutic drugs to patients." Freischem said the industry now looks forward to working with inspectors and authorities to reach a consensus on all parts of the risk-based GMP requirements set out in the guidelines "This is a prerequisite to ensuring a consistent approach that enables manufacturers to develop innovative and advanced treatment drugs of reliable quality, while balancing the burden of treatment with the benefits of patients," she said After the publication of the final guidelines, PIC / s praised the opportunity provided by the committee to "listen to the questions raised by PIC / s participating agencies", noting that the guidelines "have been revised throughout and after the consultation." PIC / s said a working group had been set up to assess the final guidelines and "looks forward to addressing concerns raised by PIC / s participants to ensure patient safety protection and to meet common standards in the GMP area of ATMP." In order to fulfil its responsibilities, PIC / s indicated that it would continue to expand opportunities for cooperation with the Committee The risk based approach Committee explained that in the final guidance, GMP requirements will be adapted to the specific characteristics of ATMP to address new situations such as decentralized manufacturing, automated production and ATMP recovery The guidelines take a risk-based approach, giving manufacturers some flexibility in their processes and control systems, depending on the level of risk In addition, the Committee stated that, in accordance with Article 15 of the ATMP regulation (EC / 1394 / 2007), the guidelines provide that manufacturers of ATMP shall retain traceability data for 30 years Due to the unique challenges brought by the production of ATMP (for example, the limited availability and inherent variability of starting materials, short validity period and small batch), the application of GMP is considered to be a problem for the developers of ATMP The finalization of the GMP guidelines was listed as one of the key points in an action plan recently issued by the European Commission and the European Drug Administration (EMA) to simplify the development and evaluation of ATMP The introduction of adaptability to ATMP in the GMP framework ensures high quality ATMP and high level of patient protection In addition, the guidelines are expected to make a significant contribution to the development of these products and provide more opportunities for patients to participate in the European Union's ATMP clinical trials Reference European Commission finally deliveries on GMP standards for ATMPs - Pink Sheet