On 22 November 2017, the European Commission (the “Commission”) adopted new Guidelines on Good Manufacturing Practice (“GMP”) specific to Advanced Therapy Medicinal Products (“ATMPs”) (the “Guidelines”). The Guidelines provide for a specific GMP framework that is adapted to the characteristics of ATMPs. These characteristics include, for instance, the complexity of ATMPs and their possible variability as a result of the use of biological materials and/or complex manipulation steps.
The Guidelines also address novel set-ups such as automated production and decentralised manufacturing and contain rules to ensure that cells or tissues contained in ATMPs can be traced for at least 30 years after the expiry date of the product.
The adoption of the Guidelines is a first result of the Action Plan on ATMPs which the Commission and the European Medicines Agency launched on 20 October 2017. The Action Plan aims to improve the regulatory framework for ATMPs by (i) providing extra guidance; (ii) reducing the administrative burden; and (iii) avoiding discrepancies across the EU (See, Van Bael & Bellis EU Life Sciences Alert of 23 October 2017).
The Guidelines apply to ATMPs that have been granted a marketing authorisation as well as to ATMPs that are being tested or used as reference in a clinical trial. They take a risk-based approach, allowing manufacturers to tailor their pharmaceutical quality system, including control and mitigation measures, to the specific risks of the ATMP and the manufacturing process concerned.
ATMP manufacturers should comply with the Guidelines by 22 May 2018 at the latest.
