MHRA Outlines Process for Using Advanced Therapies in Hospitals

Drugmakers seeking approval for advanced therapy medicinal products (ATMPs) to be used in UK hospitals do not need direct approval from the European Medicines Agency but still must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The hospital exemption scheme, which is included in a European Commission regulation on ATMPs, is designed to accelerate approval of ATMPs that are prepared and used in a hospital in accordance with a medical prescription for an individual patient, the MHRA says in a guidance posted on its website last month.
International Pharmaceutical Regulatory Monitor