The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals

An article published in Clinical Pharmacology & Therapeutics by the European Medicines Agency (EMA), describes the interactions needed between stakeholders to accelerate patient access to ground-breaking new therapies. Read more “The recent authorisation of an innovative therapy highlights the key players in gaining accelerated approvals”

How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance which outlines the procedures that the MHRA plan to introduce to regulate biological medicines in the event of a no-deal Brexit. The guidance covers United Kingdom (UK) marketing authorisation for biosimilars, marketing authorisation applications for advanced therapy medicinal products (ATMPs) and plasma master files (PMF) post Brexit. Read more “How will the MHRA regulate biological medicines including biosimilars, ATMPs and PMFs in the event of a no-deal Brexit?”

European Commission opens consultation on a new draft guideline on GCP for ATMPs

The European Commission (EC), European Medicines Agency (EMA) and the expert group of the competent authorities of the Member States have developed a new draft guideline on good clinical practice (GCP) for advanced therapy medicinal products (ATMPs). A consultation on the draft guideline is open, and stakeholders are invited to comment by 31st October 2018 at the latest. Read more “European Commission opens consultation on a new draft guideline on GCP for ATMPs”

EMA releases draft revised guidance on safety and efficacy follow-up and risk management for ATMPs

The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management for advanced therapy medicinal products (ATMPs). The revised guidance is part of the joint action plan published by the European Commission and EMA in October 2017 which aims to streamline procedures and better address the specific requirements of ATMP developers. Read more “EMA releases draft revised guidance on safety and efficacy follow-up and risk management for ATMPs”

EMA provides updated advice on the evaluation of ATMPs

The European Medicines Agency (EMA) has updated procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The objective of the update is to streamline procedural aspects and strengthen collaboration between EMA’s scientific committees. Further aims include addressing the specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines handle the regulatory process in the European Union (EU). Read more “EMA provides updated advice on the evaluation of ATMPs”