The first part of this article was devoted to general issues of safety monitoring (SM) and the role of Roszdravnadzor in the organization and carrying out of SM of BMCP.

This article will refer to the responsibility of the manufacturer and authorized representative of the manufacturer (ARM) in the part of safety monitoring of BMCP.

Thus, according to the FZ 180 “On biomedical cell products” the manufacturer of BMCP and ARM, as well as legal entities, which have permission to conduct clinical trials of BMCP, are obliged to receive, record, process, analyze and store messages about:

• Adverse reactions (serious, unforseen);
• Peculiarities of interaction with drugs and medical devices, foodstuffs and other BMCP;
• Individual intolerance;
• Facts and events that threaten the lives and health of people;

When the abovementioned events are identified, information about them must be passed along to the Roszdravnadzor within 15 days. (Further actions of Roszdravnadzor are considered in the first part of the article-see the link).

In addition, the report on the results of safety monitoring is rendered to Roszdravnadzor in the prescribed form (order № 836) every 5 years when the procedure of re-registration of BMCP is conducted.

This document contains 15 items including the following information:

1. Name and address of the manufacturer or ARM
2. Number and date of registration certificate
3. BMCP names
4. Period of monitoring
5. Date of provision of monitoring results
6. Monitoring results

In addition, the monitoring report also includes information on:

7. Registration of BMCP in foreign countries,
8. Cases of suspension of application and (or) prohibition of the use of BMCP in foreign countries
9. Refusals to register BMKP in foreign countries
10. Clinical trials conducted on the territory of the Russian Federation and abroad
11. Number of patients who applied BMCP
12. Number of BMCP packages received in circulation on the territory of the Russian Federation and foreign countries
13. Undesirable reactions (including serious, unforeseen) in the application of BMCP
14. Suspension of application of BMCP on the territory of the Russian Federation
15. Decisions on amendments to the instruction for use of BMCP

This report is the main document on the basis of which the examination of the relationship of the expected benefit to the possible risk is made and the decision on confirmation of the state registration of BMCP is taken.

Within 10 days the expert center considers a dossier, and also sends the request to Roszdravnadzor on granting of results of SM of BMCP which should be executed within 5 working days.

References:

1. ФЗ 180 «О биомедицинских клеточных продуктах»
2. Приказ Минздрава России от 20.10.2017 № 836н