On 25 January 2023, the UK government published its response to the consultation on Point of Care (POC) manufacturing, described as personalised medicines made for the patient either within or very close to the healthcare setting. The joint consultation between the MHRA and the Northern Ireland Department of Health sought views on legislative proposals to introduce a new regulatory framework for the manufacture and supply of POC products. Those proposals were warmly received by stakeholders and steps will now be taken to introduce amendments to the legislative framework for POC manufacture and supply.
After a public consultation last July, the EMA published its Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAH) on 23 July 2021. The Paper aims to clarify the responsibilities of the MAH in the GMP guidelines and the applicable legislation. While it is not legally binding, the EMA expects competent authorities to use the Paper as guidance when performing inspections, and so MAHs should familiarise themselves with the document. In this blog we have summarised the key takeaways.
Continue Reading EMA Reflection Paper on Good Manufacturing Practices and Marketing Authorisation Holders
On 16 October 2019, the European Commission published the Guidelines for Good Clinical Practice (GCP) specific to advanced therapy medicinal products (ATMPS) covering gene therapies, cell therapies and tissue engineered products. These Guidelines are available at the website of the European Commission.
The European Commission was legally required to adopt the GCP Guidelines specific to ATMPs (the Guidelines) by Regulation (EC) No 1394/2007 (ATMP Regulation) with the technical input from the European Medicines Agency (EMA). The Guidelines were adopted after a period of public consultation with the targeted stakeholder consultation in the second half of 2018.
The Guidelines reflect the experience gained by the European Commission and the EMA in the field of ATMPs and in the assessment and authorisation of this type of medicinal products. Due to their complex nature, ATMPs present specific practical operational and regulatory challenges related to GCP compliance.…