EMA Revises Guidance on Advanced Therapies - - BioPharm International

ADVERTISEMENT

EMA Revises Guidance on Advanced Therapies


The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) has revised its Draft Reflection Paper On Classification Of Advanced-Therapy Medicinal Products (ATMPs) to clarify which drugs may be classified as ATMPs (i.e., innovative drugs made from tissues, genes, or cells). The paper also takes a look at borderline cases and evolving scientific knowledge.

The paper clarifies what constitutes a substantial manipulation of cells or tissues, defines non-homologous use of cells or tissues, clarifies when drugs based on recombinant viral vectors are considered as vaccines against infectious disease and not as gene-therapy medicinal products, and sets criteria for combined ATMP classification.

An ATMP classification offers incentives such as fee reductions and is usually the first connection between EMA and ATMP developers. According to the agency, it can help sponsors identify applicable regulatory framework for their drug development path.

The paper is open for public consultation until Oct. 31, 2014.

Source: EMA

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

GPhA Supports Restricted Access Bill
September 18, 2014
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
PDA Announces Technical Report on Drug Shortages
September 9, 2014
Infinity and AbbVie Collaborate to Develop Oncology Drug
September 5, 2014
Author Guidelines

Click here