Meeting of ICMRA

Mikhail Murashko, Head of Roszdravnadzor, attended the 12th Summit of the Regulatory Agencies’ Heads and took part in the annual meeting of the International Coalition of Medicinal Regulatory Agencies (ICMRA).

Mikhail Murashko, Head of Roszdravnadzor, attended the 12th Summit of the Regulatory Agencies’ Heads and took part in the annual meeting of the International Coalition of Medicinal Regulatory Agencies (ICMRA), both of which were held in Kyoto (Japan) on 24–27 October, 2017.

Key topics discussed at the Summit and at the ICMRA meeting were in support of innovations and the further expansion of international co-operation. Specific attention was given to issues related to regulatory development and the implementation of regenerative medical solutions. The following directions were marked as key priorities for further co-operation: usage of real medical practice data (so called Real-World Data, RWD), usage of real world evidence (RWE), operations with clinical databases (those including receipt DBs, patient ledgers, insurance companies’ DBs and healthcare data registers), implementation of advanced treatments (such as cancer immunotherapy and induced stem cell therapy), joint efforts in fighting rising antibiotics resistance and actions to prevent the trade in forged and counterfeit medical products.

During the Summit, Mr. Murashko presented his report on co-operation between Roszdravnadzor and law enforcement and customs bodies of the Russian Federation, as well as co-operation with Interpol, intended to discover and curtail the illegal trade in medical products. The audience seemed to be really interested in Roszdravnadzor’s experience of this.

During the ICMRA meeting, the following projects of the Coalition were summarised: regulation of the circulation and tracing of medical products; post-vaccination issues and management of big data; methodology of crisis management; implementation of Best Practice in order to ensure broad access to safe, efficient and innovative medicinal drugs of good quality within the population.

During the year, Roszdravnadzor’s representatives actively participated in the working party’s operations in tracing ICMRA medical products, based on their field experience of implementing the tracing system for the circulation of medical products in the Russian Federation. As a result of negotiations and discussions held at the ICMRA annual meeting, further expansion of Roszdravnadzor’s participation in ICMRA working parties was confirmed and agreed.

Roszdravnadzor’s membership in the ICMRA allows experts from Russia to take an active part in the discussion and development of the most advanced regulatory practices, and encourages them to use this experience for further improvement in terms of supplying citizens of the Russian Federation with good quality, effective and safe medicinal drugs.

Information from Roszdravnadzor: ICMRA is the key forum to discuss the most pressing issues in global regulatory activities, and is a body to coordinate strategies at the level of Heads of the Regulatory Agencies. The following countries list their regulatory agencies as participants of ICMRA: Australia (TGA), Brazil (ANVISA), EU (ЕМА), Great Britain (MHRA), Ireland (HPRA) and some other European countries, China (CFDA), Republic of Korea (MFDS), USA (FDA), Canada (HC), SAR (MCC), Singapore (HAS), Japan (PMDA and MHLW), etc. Russia (Roszdravnadzor) has been a member of ICMRA since 2016.