BMCP safety monitoring. Part 1. The role of Roszdravnadzor.
One aspect of regulating the circulation of medicines, medical devices and biomedical cell products (BMCP) is safety monitoring (SM). Thus, for BMCP since the beginning of 2017, several normative and legal acts regulating this issue have been adopted. But before document analysis, it is important to answer the following questions: What is safety monitoring? What are its purposes?
- What is SM?
In the analyzed normative-legal documents (FZ № 323, FZ № 180) there was no clear definition of safety monitoring in relation to BMCP. However, it is possible to conclude that BMCP safety monitoring is a set of measures aimed at identifying, assessing and preventing of possible negative effects of the product application.
The responsibility for carrying out the SM of BMCP lies with the Federal Service for Surveillance in Healthcare (Roszdravnadzor), as well as the holders of registration certificates and authorized representatives of the manufacturer.
- What is the role of Roszdravnadzor?
Holding of SM is one of the responsibilities of Roszdravandzor (more information here). SM is carried out in the form of selective quality control pf BMCP, which is carried out in accordance with the sampling plan, which is published on the website Roszdravnadzor. One more situation when SM is conducted is when there is any information about infliction of life and health harm of citizens. (Order of the Ministry of Health of Russia from 27.03.2018 N 127 n “On approval of the procedure of selective quality control of biomedical cell products”)
One more draft of the legislative document – Order of Roszdravnadzor “On approval of the procedure for monitoring the safety of biomedical cellular products – is at the development stage. According to this project SM of BMCP is conducted by Roszdravnadzor on the basis of information received in the form of:
– Messages of BMСP circulation participants.
– Generalized reports on the safety of registered BMCP from holders of RC or authorized representatives.
– Generalized messages on safety of developed BMCP from organizations conducting clinical research, or authorized representatives.
– Information received during the implementation of the State control in the field of BMCP circulation.
In order to star safety monitoring Roszdravnadzor generates a task that contains the following information:
- Type and method of tests as well as object of tests for determination of conformity of indicators to requirements of normative documentation (ND) on BMCP
- Test period
- Period of delivery of samples by the manufacturer
- Peculiarities of testing
After that, the samples and the package of documents attached to them are sent to the expert organization, where within 40 days tests of samples and documents are conducted for compliance with the requirements of normative documentation:
In accordance with the findings of tests the expert organization prepares report, containing the conclusion on compliance of BMCP to requirements on BMCP (positive expert decision) or on non-compliance with requirements of ND (negative expert decision).
In case of positive expert decision the further circulation of BMCP is possible.
In case of negative expert decision Roszdravnadzor gives the holder of the BMCP the decision to withdraw the batch (series) of BMCP from circulation and its destruction.
If nonconfirmity of BMCP quality is found out one more time, Roszdravnadzor puts BMCP under the serial selective control. In this case, the BMCP comes into circulation on the basis of the relevant decision Roszdravnadzor.
On the basis of not less than three positive expert opinions BMCP can be transferred back to selective quality control.
- FZ № 180 “On Biomedical Cell Products”
- FZ № 323 “On the basis of health protection of citizens in the Russian Federation”
- Order of the Ministry of Health of Russia from 27.03.2018 N 127 n “On approval of the procedure of selective quality control of biomedical cell products”
- Draft of the Order of Roszdravnadzor “On approval of the procedure for monitoring the safety of Biomedical Cell Products”