This page provides information about other organisations who are involved in the regulation of advanced therapy medicinal products, and links to their websites.
In this section...
Regulators
The European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The Human Tissue Authority (HTA)
The Human Tissue Authority (HTA) is the UK's regulator that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. The HTA also give approval for organ and bone marrow donations from living people.
The Human Fertilisation and Embryology Authority (HFEA)
The Human Fertilisation and Embryology Authority (HFEA) is the UK's independent regulator overseeing the use of gametes and embryos in fertility treatment and research. The HFEA licenses fertility clinics and centres carrying out in vitro fertilisation (IVF), other assisted conception procedures and human embryo research.
Advice
The Innovation Task Force (ITF)
The Innovation Task Force (ITF) is a multidisciplinary group that includes scientific, regulatory and legal competences, set up to ensure European Medicines Agency-wide coordination in the areas of interest and to provide a forum for early dialogue with applicants.
The ITF, within eight weeks of receipt of a request from an applicant, arranges free-of-charge briefing meetings to facilitate the informal exchange of information and the provision of guidance early in the development process. Where appropriate, this is done in liaison with the Agency's scientific committees, working parties and expert groups, and takes into account ongoing international activities.
Industry
The BioIndustry Association (BIA)
The BioIndustry Association (BIA) is the trade association for innovative enterprises in the UK's bioscience sector.
The Association of the British Pharmaceutical Industry (ABPI)
The Association of the British Pharmaceutical Industry (ABPI) is the trade association for more than 90 companies in the UK producing prescription medicines for human use.
The Association of British Healthcare Industries (ABHI)
The Association of British Healthcare Industries (ABHI) is the trade association for the medicnal technology sector in the UK.
Knowledge transfer networks
The Knowledge Transfer Networks (KTNs)
The Knowledge Transfer Networks (KTNs) aim to improve the UK's innovation performance by increasing the breadth and depth or the knowledge transfer of technology into UK based businesses and by accelerating the rate at which this process occurs.
