IHS Global Insight
February 13, 2018
By Janet Beal
The Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (AFPES) has submitted letters to the state Duma health protection committee, criticizing draft legislation that would tighten the conditions for monitoring the quality of vaccines, according to Vademecum. Under the new legislation, each vaccine series would be required to undergo mandatory approval by Roszdravnadzor. The manufacturers have stated in the letter that this measure would result in a substantial increase in costs and in time to launch and could even disrupt vaccine supplies for the national immunization calendar. The draft legislation in question is a proposed amendment of the federal law “On the circulation of medicines.” Particularly stringent new quality control measures will apply to immunobiologicals, such as vaccines, toxins, sera, immunoglobulins, and allergens.
The bill, if passed, will require laboratory monitoring of each new series and only in federal institutions, with permission from Roszdravnadzor. The AFPES has calculated that the cost of launching a new vaccine series into circulation could grow from RUB127,800 (USD2,188) to RUB319,000. In addition, more stringent controls could lead to delays in the release of important vaccines if additional laboratory tests were required—leading to possible shortages with social consequences. The AFPES has proposed that duplication of quality tests should be avoided and that more accredited laboratories should be allowed to participate in the scheme. Russian manufacturer Natsimbio has agreed with this stance, according to Vademecum.
The new vaccine quality certification regulations follow concerns last year from the Ministry of Health (MoH) over the delivery of substandard products on the Russian market. However, the industry had issued warnings earlier in the year over possible bureaucratic delays and shortages resulting from such a step.
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