Current issue #19, 2015

GMP losing momentum

Experts discussed main reasons of GMP incompliance

According to PharmVestnik’s source at the Ministry of Industry and Trade, inspection of 100 manufacturing sites made last year resulted in suspension of production licenses of 20 pharmaceutical facilities operating in Russia. The implementation of GMP standards, which is a must for each Russian drug manufacturing facility starting from January 1, 2014, revealed integrated problems of many domestic manufacturers. What shall be done to work out quality management systems and harmonize efforts by the staff in line with the GMP philosophy? These were the key issues covered by the conference “Quality Assurance in the Russian Pharmaceutical Production” held in Moscow on May 27—28.

[PharmVestnik # 19, 09/06/2015, p. 1, cont’d p. 2]

Silence of the lambs

It is only experts who speak about shortage of money in Russian healthcare

In late April, the Russian Auditing Chamber published a report on budget implementation at all levels as of Q115. The auditing agency stated that the fiscal gap of the Federal Compulsory Medical Insurance Fund has exceeded the planned parameters nearly twofold. The auditors believe that if insurance premiums continue being collected at the same rate as now the money may not last through the end of the year. However, representatives of the Ministry of Health and a variety of the ministry’s offices do not think it to be a problem. When speaking officially, they keep reporting on successes of the Russian healthcare.

[PharmVestnik # 19, 09/06/2015, p. 3]

The same but with a green button

Manufacturers of medical devices state that specifications for products required by clinics are developed for specific vendors

There is a change of priorities in the medical devices sphere. Whereas previously, the main problem for manufacturers was registering their products, and not everyone could survive this process, presently it is problems related to sales of medical devices that have come to the fore. There problems were voiced at the Congress of Pharmaceutical and Medical Industry Workers held in Moscow on June 2.

[PharmVestnik # 19, 09/06/2015, pp. 4-5]

Apprising look

Implementation of health technologies assessment in Russia to start from July 1

The notion of an integrated drug assessment will be legally enforced for the first time on July 1 after amendments to the law “On Drug Circulation” come in force. Making use of international approaches ...