On January 19, 2018 State Duma has passed in the first reading the introduced by Russian Government draft law1 (hereinafter — the “Draft law”) providing changes to the Federal law dated 12.04.2010 No. 61-FZ “On drugs (medicines) circulation” (hereinafter — “61-FZ”).
The main changes proposed by the Draft law include the following:
1. Securing the right of foreign drugs (medicines) manufacturers to submit the decision on carrying out an audit instead of a GMP certificate
The Draft law provides an opportunity for foreign drugs (medicines) manufacturers to submit the authorized federal executive authority’s decision on carrying out an audit of such foreign manufacturer2, in case he does not have a certificate on compliance with good manufacturing practice rules (hereinafter — “GMP Rules”) issued by the authorized federal executive authority (hereinafter — “GMP certificate”).
A decision of the authorized federal executive authority on carrying out an audit can be submitted within the set of documents for:
- State registration of drug (finished product);
- Confirmation of drug (finished product) state registration;
- Introduction of amendments to the documents in registered drug (finished product) registration dossier.
Only provision of a GMP certificate is allowed under 61-FZ at this moment. Furthermore, GMP certificate is granted following an audit of the production site of the drug’s (finished product’s) manufacturer (hereinafter — “GMP audit”). The time period for conducting foreign manufacturers’ GMP audit may take around 10 months, so the changes proposed by the Draft law speed up significantly the process of the drug (finished product) release to the Russian market, as well as confirmation of its state registration and amending its registration dossier.
2. Introduction of a new ground for suspension of drug (finished product) use
Current wording of art. 65 of 61-FZ stipulates the following grounds for suspension of a drug (finished product) use:
- Receiving by the authorized federal executive authority information on adverse undocumented reactions when using drug (finished product), its serious adverse reactions, its interaction specifics with other drugs (finished products), which are in fact or can be fatal or life-threatening to people or animals, as well as information on the inconsistency in actual and documental efficiency and safety data on a drug (finished product);
- In case of failure or improper performance of pharmacovigilance duties by holders or owners of a drug (finished product) market authorization, legal entities indicated in the Russian clinical trial authorizations, or their other authorized representatives;
- In case of granting by the relevant authorized federal executive authority of a certificate on unreliability of medical drug’s (finished product’s) clinical trial results based on the results of audit held in respect of medical organization responsible for conducting of such clinical trials in contravention of the good clinical practice, which entailed unreliable results achievement;
- In case of failure to meet requirements of the injunction issued by the authorized federal executive authority following the selective quality control monitoring of the drug (finished product).
Draft law expands list of grounds for suspension of drug (finished product) use. Apart from the aforementioned grounds, the authorized federal executive authority considers whether it is necessary to suspend use of drug (finished product) use when the following information is available:
More specifically, use of a drug (finished product) will be suspended provided the following data is available:
- Manufacturing of drug (finished product) with structure and(or) manufacturing process including description of production stages different from those indicated in the registration dossier;
- Manufacturing of drug (finished product) on the production site not specified in the registration dossier;
- Manufacturer’s failure to resolve within the agreed with the relevant authorized federal executive authority time limits any inconsistencies in drug (finished product) manufacturing with GMP Rules revealed during audit held in respect of drugs (medicines) manufacturer and(or) during licensing supervision in drugs (medicines) manufacturing area;
- Manufacturer’s lack of documents confirming quality conformance of drug (finished product) put into civil circulation to the requirements established for its state registration.
Therefore, Draft law contributes to reducing the time of access of drugs (finished products) to the Russian market, followed by development of contract production of drugs (finished products) in the Russian Federation. Russian manufacturers will have extra incentive to the production of drugs (finished products) manufactured outside the Russian Federation, which in turn will ensure the promotion of competition in the Russian pharmaceutical market, will create the necessary conditions for the growth of exports of Russian drugs (finished products).
On May 17, 2018 following the Draft law consideration, State Duma has passed the relevant law in the third reading.
1http://sozd.parlament.gov.ru/bill/327290-7
2Under clause 11 of the Decree of the Russian Government dated 03.12.2015 No. 1314 “On determining of compliance by drugs (medicines) manufacturer with good manufacturing practice rules” decision on carrying out an audit is passed when application and documents submitted for GMP certification upon their consideration are recognized as consistent with the established requirements