President of Kyrgyzstan Sadyr Japarov has signed a law amending the regulations on the circulation of medicines and medical products. The document aims to simplify the registration procedure for certain pharmaceuticals and will enter into force in ten days.
Under the amendments, the accelerated registration procedure will now apply to strategically important medicines, as well as to drugs produced in Kyrgyzstan.
Additionally, an automatic registration procedure is being introduced. It will apply to medicines that are:
- included in the World Health Organization’s list of prequalified medicines;
- registered by leading global regulators — the FDA (USA), EMA (European Union), PMDA (Japan), Swissmedic (Switzerland), or MHRA (United Kingdom);
- classified as orphan drugs, meaning they are intended for the treatment of rare diseases;
- procured through UN-established organizations operating under agreements with the Cabinet of Ministers.
The Cabinet will determine the procedure and cost of accelerated and automatic registration.
Amendments have also been made to the law on the circulation of medical products: the procedure for inspecting manufacturers and the associated fees will now also be approved by the Cabinet.
According to the authors of the bill, the law will speed up the supply of quality medicines to the country, reduce bureaucratic barriers, and improve citizens’ access to essential medicines.
