Russian Federal law 180-ФЗ on cellular therapy products (CTPs) has come into force this summer. This law is intended to help researchers, industry and healthcare providers to develop and implement CTPs in clinical practice. Until 2016, the field of CTPs was barely regulated in Russia at all. Only one CTP is currently registered in Russia, and more detailed legislation is required to promote development and registration and CTPs, that’s why MoH recently released several draft legislative acts (referred further as “act”).
According to the draft act that defines requirements for registration dossier, an applicant must submit a pretty standard set of documents (labeling information, study protocol, informed consent form, the summary of product characteristics [SmPC] e.t.c). Also, an applicant should submit preclinical and clinical study reports of the new CTP and applicant will receive special treatment if an international multicenter study report will be provided. In this case, an applicant must submit only SmPC, labeling information and international multicenter study report along with drug approval application. One-step approval is allowed in this case, whereas if multicenter study reports are not provided, approval will include several consecutive steps.
Russian MoH also published draft acts regarding CTP development, shipping, and expertise (quality and efficacy control). Again, an applicant can use a simplified procedure if international multicenter study reports are provided and no additional quality and efficacy control will be required.
MoH also released draft act that defines rules for the prohibition of post-mortem CTP donation. Per current legislation, if a person has not prohibited donation of cells before death, a spouse or relatives can still consent to donate one’s cells. Today there are no specific guidances for CTP preclinical or clinical development in Russia while US FDA implemented such guidance back in 1998. Yet, since Russian MOH developed such interest in CTPs, one can expect that such guidance can appear in Russia quite soon.