• Russian Ministry for Industry and Trade adopted rules for organising the production and quality control of drugs
• Draft Law “On Amendments To the Federal Law ‘On the Circulation of Medicines’” to be submitted for consideration to the State Duma in November
• Ministry for Healthcare planning to implement pilot drug insurance projects in 2014
• Plan approved to implement Development of Health state programme by 2015
   

Rules for organising the production and quality control of drugs (GMP) have been approved by Russian Ministry for Industry and Trade Decree No. 916 of 14 June 2013.

The rules set out detailed information on the principles of due process related to active (pharmaceutical) substances used as raw materials. Compliance with the regulations will be taken into account when issuing to pharmaceutical companies licenses to manufacture drugs.

Thus, starting from 1 January 2014, according to the Law “On circulation of Pharmaceuticals” production of all pharmaceutical companies should be in compliance with GMP standards.

http://pharmapractice.ru/97195

http://pharmapractice.ru/97197

http://1prime.ru/Pharm_industry/20131011/767936450.html
 

An assistant to Russian Healthcare Minister Elena Maksimkina has reported that work on the draft law to amend the Federal Law "On Circulation of Pharmaceuticals" is now complete.

The draft law introduces:

• the concept of "biologic pharmaceuticals", " orphan drugs", as well as others;
• the registration procedure requirements for the above.

In addition, clarifications have been introduced to the existing law related to terms already in legal use, and additional requirements have been added with respect to the regulatory requirements for registration certificate holders of the subject medical products. Furthermore, the following changes should be noted:

• an expansion in the powers and responsibilities of federal authorities;
• the creation of a list of pharmaceutical dosage forms (in order to exclude various pharmaceutical dosage forms which in substance do not perform any medical action, but only have the advantage of having distinguishing features for purchasers);
• the significant addition of Article 9 to the draft law, in relation to state quality control over drugs;
• more stringent requirements for and introducing manufacturer responsibility related to providing reliable data on the quality of manufactured drugs.

The final version of the draft law will be submitted to the Russian Government in early November, and to the State Duma by the end of the year.

www.pharmvestnik.ru/publs/lenta/v-rossii/zavershena-rabota-nad-zakonoproektom-o-vnesenii-izmenenij-v-fz-ob-obraschenii-lekarstvennyx-sredstv.html
 

Drug insurance refers to the system in which, when purchasing medicines prescribed by a doctor, the patient who has a compulsory health insurance policy pays only a portion of their cost, with the remainder being covered by the policy.

Under plans set out in the law, the drug insurance system, or other system for reimbursing the cost of drugs, will be introduced in Russia not earlier than 2016; however, for this happen, pilot projects must be conducted in several Russian regions.

During 2013 regions must prepare for the launch of a pilot project. If the experiment proves to be a success, then the system will be rolled out across the country. However, the drug insurance system will not be implemented throughout Russia until 2015, due to financial constraints.

In the Beloholunitsk territory of the Kirov Region a drug insurance project has been already launched. This is the second territory in Russia to take part in the new project.

www.pharmvestnik.ru/publs/lenta/v-rossii/v-kirovskoj-oblasti-rasshiren-proekt-lekarstvennogo-straxovanija.html
 

Russian Government Decree No. 1702 of 21 September has approved the plan to implement the Russian Federation “Development of Healthcare” state programme for 2013 and for the 2014 and 2015 planning periods.

Of special note is that as part of the implementation of Subprogramme 1 the following should take place:

• the legal regulation of issues related to creating lists of drugs (delivery date: 30 November 2013)
• regulating the procedure for creating lists of drugs procured in accordance with their trade names (delivery date: 30 November 2013)
• Establishing a list of drugs procured in accordance with their trade names (delivery date: 1 June 2015)
• Establishing the procedure for the state registration of drugs for medical use in the treatment of rare (orphan) diseases (delivery date: 1 June 2015)
• Ensuring the state regulation of prices for drugs for medical use, including by developing a system of reference prices (delivery date: 1 December 2014)