Specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the guideline ST-N MOZU 42 – 9.0:2024 “Medicinal products. Classification of advanced therapy medicinal products,” approved by order of the Ministry of Health of Ukraine of 20.03.2024 No. 480.
The purpose of this document is to provide guidance on the classification procedure for advanced therapy medicinal products, and on the interpretation of the key concepts in the definitions of a gene therapy medicinal product, a somatic cell therapy medicinal product, a tissue engineered product and a combined advanced therapy medicinal product.
The guideline reflects the experience gained in applying the classification procedure at the EMA, FDA and WHO. The document is intended to harmonize the regulatory framework in order to improve product safety, ensure efficacy and prevent the exploitation of donors and patients. It is expected that this, in turn, will facilitate both the development of and access to advanced medicinal products.
The main aspects covered in this document include:
- providing definitions of key terms;
- classification of human cells and tissues for medical use (HCT) and advanced therapy medicinal product (ATMP);
- use of a risk-based approach to regulatory oversight of HCT and ATMPs;
- key elements of an effective regulatory framework.
This guideline is applied together with the provisions of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials and the Model Regulations on Ethics Committees, approved by order of the Ministry of Health of Ukraine of September 23, 2009 No. 690, as amended, registered with the Ministry of Justice of Ukraine on October 29, 2009 under No. 1010/17026.
You can familiarize yourself with this guideline at the link.
