Kazakhstan to ease and accelerate registration of new medicines
Kazakh Majilis adopted amendments in the second reading to the law on science, introducing significant changes to the registration process for new medicines, Qazinform News Agency reports.
According to deputy Askhat Aimagambetov, current registration can take up to 210 days, but in practice often lasts years.
He said it suggests introducing a new composite service that will combine registration, expert review, price approval, and inclusion in the National Drug Formulary. This will reduce the process to 100 days.
A fast-track procedure will be introduced for medicines already approved by strict international regulators (FDA in the U.S., EMA in Europe)
The Healthcare Ministry will gain the right to initiate registration of vital medicines from the WHO list.
Besides, the draft law provides stronger oversight of pharmaceutical substances produced domestically. Imported substances must undergo mandatory testing and approval.
To note, relatives of citizens in long-term comatose states will be allowed to apply for disability certification on their behalf. This ensures timely access to benefits and rehabilitation tools, avoiding delays caused by lengthy court procedures for guardianship.
It should be noted, Kazakhstan to register its first homegrown cancer drug by year-end.
