A pilot project for the registration of medicines and medical devices based on the "single window" principle has been launched in Kazakhstan. The new mechanism allows for a significant acceleration of the launch of products on the market - the entire process now takes no more than 100 working days. The project is being implemented in cooperation between the Ministry of Digital Development and the Ministry of Health as part of reforms to reengineer public services and digitally transform healthcare.
If today the examination of medicines can take up to 210 calendar days, pricing - up to 60 working days, and professional examination - up to 50 working days, then when using the composite state service, all these processes will be combined and take place in parallel for no more than 100 working days.
The composite state service is being implemented on a voluntary and alternative basis and is used along with the existing mechanisms for examination, registration and pricing of medicines, as well as conducting professional examination for the inclusion of medicines in the Kazakhstan National Drug Formulary.
The composite state service also provides for a joint registration procedure with the World Health Organization during the examination of medicines, as part of the prequalification and recognition of medicines by regulatory authorities with a strict regulatory system, in countries such as the USA, the European Union, Great Britain, Japan within a period not exceeding 15 working days.
The same accelerated period will be applied to medical devices manufactured at factories in countries with recognized regulatory systems.
At the same time, the composite service provides for the registration of the manufacturer's price with subsequent automatic establishment of markups for wholesale and retail sales and within the framework of the State Fund for Free Medical Care and the Compulsory Medical Insurance.
The pilot will last until July 1 of this year. If its effectiveness is confirmed, a transition to a permanent model with the abolition of outdated standards is planned. This will open a new era in the registration of pharmaceutical products in Kazakhstan - with short deadlines, high transparency and a real reduction in the administrative burden for businesses.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
If today the examination of medicines can take up to 210 calendar days, pricing - up to 60 working days, and professional examination - up to 50 working days, then when using the composite state service, all these processes will be combined and take place in parallel for no more than 100 working days.
The composite state service is being implemented on a voluntary and alternative basis and is used along with the existing mechanisms for examination, registration and pricing of medicines, as well as conducting professional examination for the inclusion of medicines in the Kazakhstan National Drug Formulary.
The composite state service also provides for a joint registration procedure with the World Health Organization during the examination of medicines, as part of the prequalification and recognition of medicines by regulatory authorities with a strict regulatory system, in countries such as the USA, the European Union, Great Britain, Japan within a period not exceeding 15 working days.
The same accelerated period will be applied to medical devices manufactured at factories in countries with recognized regulatory systems.
At the same time, the composite service provides for the registration of the manufacturer's price with subsequent automatic establishment of markups for wholesale and retail sales and within the framework of the State Fund for Free Medical Care and the Compulsory Medical Insurance.
The pilot will last until July 1 of this year. If its effectiveness is confirmed, a transition to a permanent model with the abolition of outdated standards is planned. This will open a new era in the registration of pharmaceutical products in Kazakhstan - with short deadlines, high transparency and a real reduction in the administrative burden for businesses.
Источник: Казахстанский Фармацевтический Вестник, pharmnews.kz
