Clinical trials required for registration of some generics.


Legal Update No. 200

Goltsblat BLP advises that, in its Resolution No. КА-А40/13801-10-P of 17 November 2010 on Case No. А40-65987/09-92-360, the Federal Arbitration Court (FAC) for the Moscow Circuit holds that full-scale clinical trials are required for registering generics administered by injection or infusion.

The state registration of a domestic manufacturer’s anticancer pharmaceutical analogous (generic) to that of a foreign manufacturer used as an anti-tumour drug on the Russian market followed a fast-track procedure based on Clause 11, Article 19 of Federal Law “On Pharmaceuticals”, then in effect (1). Subsequently, however, the Federal Supervisory Service for Healthcare and Social Development (Roszdravnadzor) issued an order suspending registration on the grounds that this generic’s clinical trial results did not justify the performance of this generic when prescribed for administration in accordance with its information leaflet.

The manufacturer challenged this order in the courts.

The Healthcare and Social Development Ministry of Russia argued in the proceedings that the generic was a parenteral medicine for administration by injection and, as such, could not have been registered on the basis of bioequivalence (pharmacokinetic equivalence) studies.

This argument was supported by a document entitled “Qualitative Study of Bioequivalence of Pharmaceuticals.

Methodological Guidelines” (approved by the Russian Healthcare and Social Development Ministry on 10 August 2004). This document does not include injected medicines on the list of pharmaceuticals eligible for a bioequivalence study.
The FAC for the Moscow Circuit agreed that the generic was intended for administration by injection or infusion and stated that full-scale clinical trials were required to confirm its therapeutic equivalence. 


(1) This Law has been replaced with Federal Law No. 61-FZ of 12 April 2010 “On Medicaments Handling” preserving the rules on the fast-track registration of generics.

For additional information, please contact:

Nina Belozertseva, Head of Group, Healthcare & Pharmaceuticals, Goltsblat BLP,
T: +7 (495) 287 44 44,

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