- Amendments to the law ‘About Pharmaceuticals’ to promote the introduction of the latest innovative developments to the market
- 9 July, 2008
- Galina Baryshnikova
- (FEDERAL NEWS) The Ministry of Health and Social Development and the Ministry of Industry and Trade are developing a draft law “About Making Amendments in Federal Law 89 ‘About Pharmaceuticals’”, which is to take into account interests and priorities of the national pharmaceutical industry. This was the point that Andrei Gaiderov, the Deputy Head of the Department for pharmaceutical operations in the regional and informational policy in Health and Social Development of the Ministry of Health and Social Development of the Russian Federation, made at the Round Table meeting ‘How to make pharmaceutical industry achievements available for Russian people’; the meeting took place in the Federation Council on 8 July. ‘Application of the provisions of this draft law must bolster the development of the Russian national pharmaceutical industry and decrease the time period needed for the latest innovation technologies to enter the market,’ said an officer of the Ministry of Health and Social Development. He was hopeful that the State Duma and Federation Council would support the draft law ‘About Pharmaceuticals’.
The draft law provides for the perfection of the scheme, which permits pharmaceuticals to enter Russia, for the increase in the responsibility of all parties dealing with pharmaceuticals for, in the first place, the efficacy and security of pharmaceuticals, said Andrei Gaiderov. It is planned to make amendments in the legislation in effect with regards to regulating the requirements for the management of production and quality control of pharmaceuticals. In particular, the draft law promises to streamline the licensing of pharmaceutical production through reducing administrative barriers with ensuring that the state keeps controlling the execution of all license requirements and conditions. All manufacturers working in the Russian market will be inspected. The draft law allows for producers to release medicines into circulation on the basis of confirming production terms and controlling that the quality of each series meets specified requirements, which will make it possible to increase the responsibility of the parties dealing with pharmaceuticals. Its provisions regulate the scheme of permitting pharmaceuticals to treat rare diseases, and they abolish the registration of pharmaceutical substances, Andrei Gaiderov told. He reminded that the state control for the quality of substances is maintained and there is nobody to cancel it. The draft law is supposed to have the registration period altered according to that adopted in the EU; the list of data is specified that are established for applicants to submit when registering; the state examination rules as well as those for the registration of pharmaceuticals are established there. As the draft law regulates, the procedure of registering reproduced pharmaceuticals is significantly alleviated, and this will allow to provide the market more efficiently with pharmaceuticals of high demand. The new law deals a lot with securing intellectual property, which the applicant submits when registering and examining pharmaceuticals, in particular those generated at clinical and pre-clinical studies. This law provision is to secure both the copyrights of developers of innovative medicines and the fastest introduction of them into the healthcare practice, a representative of the Ministry of Health and Social Development emphasized. The law makes a provision for measures to fight the circulation of pharmaceuticals of poor quality, for perfecting the state regulation as far as import and export of pharmaceuticals in the retail business are concerned. www.canonpharma.ru
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