The new rules, most importantly, (i) limit data exclusivity protection, (ii) reinstate the grace period for medicinal preparations that recently had their registration dossier changed, (iii) lay the groundwork for revision of state regulation of prices, (iv) introduce new regulations on biological/biosimilar and orphan medicinal preparations, (v) establish interchangeability of medicinal preparations and a GxP inspectorate.
The changes were introduced with the adoption of the Federal Law “On Amendments to the Federal Law ‘On Circulation of Medicines’” (the “Amendments”). The Amendments change Federal Law No. 61-FZ “On the Circulation of Medicines” dated 12 April 2010 (the “Law”), and will affect the entire Russian pharmaceutical market. The Amendments came into force on 1 July 2015, with certain provisions coming into force at a later stage. Please note, however, that currently the Russian legislative body is reviewing the draft law postponing the entry into force of the most important provisions of the Amendments (including provisions on biological/biosimilar preparations, orphan medicinal preparations, grace periods, procedure of the state registration, data exclusivity, etc.) to 1 January 2016.
Data Exclusivity: The Amendments limit cases in which pre-clinical and clinical trials data will be protected. Now only use for commercial purposes of pre-clinical and clinical data submitted by another applicant for the state registration of medicinal preparations will be prohibited for six years after the date of state registration of the reference (original) medicinal preparation. State registration of a generic medicinal preparation may now be initiated four years (three years for biosimilars) after registration of the reference medicinal preparation. This is aimed at allowing generic medicines to appear on the Russian market immediately after the six-year data exclusivity period expires.
Grace Period: The Amendments re-establish a grace period for medicinal preparations that recently had their registration dossier changed and allow the circulation of medicinal preparations manufactured in accordance with the “old” registration dossier within 180 days after a decision of the registration authority to amend the registration dossier up until the expiration of their shelf life.
State Regulation of Prices: Previously the Law contained very detailed provisions on the state regulation of prices for Essential Drug List preparations. The Amendments shortened those provisions and the Law will now only provide a very general framework for the state regulation of prices. Detailed regulations will be adopted by the Russian Government.
Biological/Biosimilar Medicinal Preparations are finally introduced as a concept into the Law. The most important rule regulating this area is that biosimilar medicinal preparations may not be registered on the basis of a bioequivalence study; clinical trials will be necessary.
Orphan Medicinal Preparations: Under the Amendments, a medicinal preparation designed only for diagnostics of orphan diseases or their treatment aimed at the mechanics of development of a disease may obtain the status of an orphan medicinal preparation at the very beginning of the procedure for its state registration. An expedited procedure of expert examinations will apply to such medicinal preparations and it will be possible to register them on the basis of clinical trials conducted outside Russia.
Interchangeability: The Amendments introduce the definition of interchangeable medicinal preparations and parameters of interchangeability (most importantly — the same pharmaceutical substance, which should translate into the same INN). The procedure for establishing interchangeability is to be defined by the Russian Government. The Amendments call for the establishment of a register of standard instructions for the use of interchangeable medicinal preparations.
The interchangeability of new medicinal preparations is to be defined during the state registration of medicinal preparations (this does not apply to the registration of reference products). Interchangeability of medicinal preparations registered before the Amendments come into force will be defined by the state expert committee before 31 December 2017. Starting from 1 January 2018, information on interchangeability will be included in the state register of medicinal preparations.
GxP Inspectorate: The Amendments should lead to the creation of a single Russian inspectorate overseeing compliance with Russian GxP documents. The inspectorate will also conduct GMP compliance audits of foreign manufacturing sites.
Scientific Consulting: The Amendments oblige the Russian Ministry of Health to advise on the matters of pre-clinical and clinical trials, expert examinations and state registration.
Other Significant Changes:
- The Amendments shorten the maximum term for the state registration of medicinal preparations from 210 to 160 business days.
- The content of the registration dossier will now have to follow the Russian common technical document (CTD) format.
- The Amendments introduce the concept of the owner (holder) of the registration certificate, which entails various regulatory duties. In the context of biotech or orphan medicinal preparations, the owner (holder) of the registration certificate is obliged to provide samples to other companies willing to conduct clinical trials (including comparative clinical trials) using them.
- The Amendments expand the list of cases in which the state registration of a medicinal preparation may be cancelled by adding (i) any absence of the medicinal preparation from circulation in the Russian Federation for three or more years, (ii) a refusal to amend the instructions on use in response to newly confirmed data that the risk of use of the medicinal preparation outweighs the benefits.