Examination of biomedical cell products
In the section on the application of biomedical cell products (BMCP), a great deal of attention was paid to the various aspects and stages of registration. However, it is still unclear who will check the formed registration dossier at the stage of examination of BMCP? What are the requirements for experts and what level of training should they have?
It should be noted that the examination of BMCP is carried out in two stages:
- Examination of the quality of BMCP and examination of documents for obtaining permission to conduct a clinical trial of BMCP.
- Examination of the effectiveness of BMCP and examination of the ratio of expected benefit to the possible risk of BMCP application.
The main requirements for experts and examination are set out in the Federal Law № 180 “On biomedical cell products”.
According to the Federal Law, the expert can be a certified employee of an expert institution having higher medical, pharmaceutical, veterinary, biological or chemical education and who conducts biomedical examination of BMCP in fulfillment of the official duties.
In addition, the work experience of an expert in the specialty should be at least 3 years. The expert should also have extensive knowledge of the regulatory documentation at BMCP, as well as skills in sampling, research, evaluation and documentation of BMCP.
Certification of experts is carried out by qualification commissions at least once in five years and includes performance of test tasks and working out of practical skills.
In mid-December 2018, the Order “On the expert-qualification commission of the Ministry of Health of the Russian Federation on certification of experts for the right to conduct an examination of BMCP” was signed. The order determines the composition of the attestation commission, regulates its functions.
The task for examination from the Ministry of Health of the Russian Federation will be carried out by the expert center – the Scientific Center for Examination of Means of Medical Application (FGBU SCEMMA).
According to the Federal Law 180, the duties of the expert include:
- Conducting a study of the objects of research, documents and (or) materials provided to him.
- Evaluation of BMCP quality control methods.
- Issuance of opinions on questions raised
- Ensuring proper storage of the submitted research objects, documents and (or) materials.
The expert shall not have the right to:
- To carry out an examination of BMCP on the appeal directly to him of legal entities and individuals.
- Independently collect materials for the examination of BMCP.
- To consult in the field of professional activity outside the job assignment.
- To disclose information which became known to him in connection with carrying out biomedical examination of BMCP, as well as information constituting state, commercial or other secret protected by law.
- FZ № 180 “On biomedical cell products”
- Order of the Ministry of Health of Russia from 12.12.2018 № 869 “On the Expert-Qualification Commission of the Ministry of Health of the Russian Federation on the attestation of experts for the right to conduct an examination of biomedical cell cell products”