GMP Challenges for  Advanced Therapy Medicinal Products

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of Advanced Therapy Medicinal Products (ATMPs) in the EU is proving to be a complex task.

A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene and cell therapy products and tissue-engineered treatments, was due to be completed in November 2015.

The guidelines, which will be drawn up by the European Commission, however, are taking a long time to complete. They are a requirement of an EU regulation on Advanced Therapy Medicinal Products (ATMPs) which was approved in 2007.

The objective behind the guidelines is to bring together in a single document GMP standards from a variety of sources, mainly other pieces of EU legislation. But even when the first dedicated GMP guidelines for ATMPs are finalized, probably in 2016, they are likely to have to be constantly revised.

Compliance with GMP standards has been a major challenge for Advanced Therapy Medicinal Products developers in Europe. In fact, these difficulties could be a prime reason why, up until 2014, only four medicines under the ATMP regulation had been given marketing authorization in the EU’s centralized medicines licensing procedure. Just how GMP problems for advanced medicines are sorted out in Europe could be a key influence over the future of personalized medicines and other new pharmaceutical technologies in the region.