New Russian Drug Law
Russian Prime Minister Dimitry Medvedev recently signed a new law updating regulations regarding the circulation of drug products in the country. According to the Russian Minister of Healthcare and Social Development, since September 1, 2010 when the first law was passed, the current law did not address many of the acute problems specific to today's pharmaceutical industry. For example, the current federal executive bylaws did not regulate the registration and fees of drug products at all drug registration stages. Moreover, the new law has shortened the lengthy registration process that was required until now, especially for Russian-made drug products, bringing the drug registration procedure more in line with European time lines - now averaging 210 days or less.
Another aspect of the new law deals with bringing local drug manufacturers in line with current manufacturing standards. The Russian government hopes to gradually transition local drug manufacturers to meet cGMP standards by the new deadline January 1, 2014. Regulations concerning international companies outsourcing clinical trials and manufacturing to Russia have also been better defined. The new law stipulates that foreign drug products should undergo the same registration procedures as Russian ones, except for the first stage of clinical studies conducted on volunteers. However, Russian authorities will mutually recognize clinical drug studies performed by other countries as long as there is an official bilateral agreement. Finally, the new law addresses the issue of ensuring availability of drug products in rural parts of the country by allowing drug products to be sold in out-patient clinics, general practitioners' centers, at medical attendant's and medical attendant's/midwife's stations, and other types of health care centers, unless there are drug stores in that area.
The goals of the new law are in summary: 1. To streamline the registration procedure, 2. Make all stages of the drug registration process more transparent. (With this increased transparency, it is the first time that the Russian law requires monitoring of the drug product safety and makes pharmaceutical companies liable at all stages, effectively preventing sales of counterfeit drugs), 3. To improve manufacturing standards among local drug manufacturers, 4. Define regulations for international companies outsourcing clinical trials and manufacturing to Russia, 5. To expand the sales of pharmaceuticals into rural areas where currently there are no available drug stores.
References
www.ncpharm.com/110111124110111124050050050124049.html
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