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news.A new framework for advanced therapy products or ATPs is being formulated and the new EU rules are expected to come into effect by the end of 2008, according to PJB news.
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The main objective of the ATP regulation is to centralize the regulatory and scientific requirements and to help small and medium-sized enterprises gain access to all EU markets. The new framework for ATPs will comprise of a new scientific committee, a new regulatory procedure and changes in areas such as GMP and clinical trials. According to the new legislation, all gene therapy (GT), somatic cell therapy (STC) and tissue engineered products (TEPs) must use the centralized marketing authorization procedure.
As part of the new legislation, the Committee on Advanced Therapies (CAT) will be set up at the European Medicines Agency, which will evaluate new drug submissions and produce a draft opinion that goes to the EMEA’s scientific committee (CHMP) for final approval. Although the CAT will play a pivotal role in the draft opinion, the CHMP will be ultimately responsible for the final opinion. The CAT will work closely with other EMEA bodies like the orphan drugs committee and working parties on gene and cell therapy and scientific advice. It will also offer advice on any other products that require its specific expertise.
The EMEA is also offering a new rolling review process under which SMEs developing advanced therapies can submit their quality and non-clinical safety studies at an early stage and have them evaluated and certified by the CAT. This certification is not legally binding and will be independent of any subsequent marketing authorization application.
The new legislation also includes changes to the annex 2 of the good manufacturing practice (GMP) provisions that cover the manufacture of biological products. Additional approvals for facilities involved with genetically modified organisms and compliance aspects for products incorporating human tissues and cells are some of the proposed changes.
Although the new regulations are expected to apply from December 30, 2008, companies with advanced therapy products already on the market have a transitional period in which to bring them in line with the new requirements. Gene therapy and somatic cell therapy products have three years while tissue engineered products have four years of transition time. During the transitional period no fee will be charged for upgrading the products, but any products that are not brought into line by the deadline will be declared illegal.