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”

What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?

A recent document released by the European Commission (EC) outlines Good Practice considerations when assessing genetically modified organism (GMO) related aspects, during the conduct of clinical trials with Adeno-associated virus (AAV) vectors. Read more “What is considered Good Practice on the assessment of GMO aspects for in-vivo gene therapy products?”

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”