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俄罗斯药品注册程序-俄罗斯原料药注册-Russian Stages of drug registration-Russian Drug Registration
    发布时间: 2018-10-11 13:22    

俄罗斯药品注册程序,俄罗斯原料药注册,Russian Stages of drug registration,Russian Drug Registration

俄罗斯药品注册程序-俄罗斯原料药注册-Russian Stages of drug registration-Russian Drug Registration


俄罗斯药品注册



  新药注册是向俄罗斯联邦市场投放药物的第一步。药品注册是对药品质量、效率和安全进行评估的国家程序,以获得在俄罗斯联邦医疗使用药品的批准。新药注册--是退出俄罗斯联邦药品市场过程中的第一步。该程序实质上是对药物的质量、效率和安全性进行状态检查,为随后颁发药物医疗使用许可而举行。

2010年,由于通过了2010年4月12日 "关于药品流通 "的第61-ФЗ号新联邦法,该法于2010年9月1日生效,因此药品注册程序基本上被修改。到目前为止,已经通过了4项法律修改: 2010年7月27日第192-ФЗ号,2010年10月11日第271-ФЗ号,2010年11月29日第313-ФЗ号,2011年12月6日第409-ФЗ号。

俄罗斯联邦2014年12月22日第429-FZ号法律《联邦药品流通法修正案》。部分修正案将于2015年7月1日生效,另一部分将于2016年1月1日生效,最后一部分将于一年多后,即2017年1月1日起生效。


俄罗斯药品注册的程序。

俄罗斯药品注册的阶段

外国和俄罗斯的药品要经过相同的注册程序。


俄罗斯药品注册程序包括4个连续的阶段:


建立注册档案,包括启动临床研究的必要文件,并向俄罗斯联邦卫生部提交注册档案。


获得在俄罗斯联邦进行临床研究的许可。


药品质量评估和预期收益与可能风险比的评估,这是在药品临床研究后进行的: 


为方便起见,第三阶段可分为2个子阶段:


在FSBI SCEMP的实验室进行药品质量控制,批准规范性文件(规格和分析程序;


评估预期收益与可能风险的比率,并批准药品的医疗使用说明。


俄罗斯联邦卫生部决定对药品进行注册,将其列入国家药品注册登记册,并颁发上市许可。


1.建立注册档案

2. 获得在俄罗斯联邦进行临床研究的许可。

3. 药品质量评估和预期收益与可能风险比的评估,这是在药品的临床研究后进行的。

4. 4.俄罗斯联邦卫生部关于药品注册的决定,将其列入国家药品登记册并颁发上市许可。

注册时间框架

根据第61号法律--《药品流通法》,注册程序的期限为210个工作日。该期限不包括进行临床研究所需的时间。

活性药物成分(API)的注册阶段、时间框架和费用。


活性药物成分(API)可以通过以下两种方式在俄罗斯联邦境内被批准使用(注册):


作为将使用该原料药的成品药注册的一部分。


如果制造商打算只向一个特定的工厂供应原料药,那么,作为成品药注册程序的一部分,将提供信息并进行原料药质量评估。在这种情况下,该原料药只能用于被评估的药品。


不用于药品生产的活性药物成分(API)的注册。如果制造商没有决定向哪家工厂供应产品,并打算扩大市场范围,他有权申请注册不用于药品生产的API。


该原料药将被列入国家注册医药产品登记册中,并有一个单独的编号。


不用于药品生产的活性药物成分(API)的注册阶段


活性药物成分(API)的注册包括两个阶段:


原料药评估(质量控制和批准规范性文件(规格和分析程序));


在国家医药产品登记册上登记原料药。


不用于药品生产的活性药物成分(API)的注册期限: 5-7个月。


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Drug Registration



  Registration of a new product is the first step of launching drug to the market of the Russian Federation. The registration is a state procedure of drug quality, efficiency and safety evaluation to obtain an approval for medical use of a drug in the Russian Federation. Registration of a new drug - the first step in the process of withdrawal of the pharmaceutical market of the Russian Federation. This procedure is essentially a state examination quality, efficiency and safety of the drug, which is held for the subsequent issuance of the permit on its medical use.
In 2010, the drug registration procedure was essentially modified due to the adoption of new Federal Law No. 61-ФЗ “On circulation of medicines” of April 12, 2010 which became effective on September 01, 2010. To date, 4 modifications of the law have been adopted: No. 192-ФЗ of July 27, 2010, No. 271-ФЗ of October 11, 2010, No. 313-ФЗ of November 29, 2010, No. 409-ФЗ of December 06, 2011.

Law of Russian Federation on December 22, 2014 N 429-FZ on "Amendments to the Federal Law" "On Circulation of Medicines ". Some of the introduced amendments will enter into force on 1 July 2015, another part - on 1 January 2016 and the last - more than a year, that is from January 1, 2017.

The procedure of drug registration.

Foreign and Russian drugs undergo identical registration procedure.

The registration procedure consists of 4 sequential stages:

  1. Creation of a Registration dossier including documents necessary for clinical study initiation, and submission of the Registration dossier to the Ministry of Health of the Russian Federation.

  2. Obtaining a permission for the conduct of a clinical study in the Russian Federation.

  3. Drug quality evaluation and evaluation of the expected benefit to possible risk ratio which is done after the clinical study of a drug: 

    The third stage may be divided into 2 sub-stages for convenience:

    1. Drug quality control at the FSBI SCEMP’s laboratory and approval of a Normative document (specification and analytical procedures;

    2. Evaluation of the expected benefit to possible risk ratio and approval of Instruction for medical use of a drug.

  4. Decision by the Ministry of Health of the Russian Federation on registration of the pharmaceutical product, it’s entering in the State Register of pharmaceutical products and marketing authorization issuance.

Registration time-frames


According to Law No.61-Federal Law “On circulation of medicines”, the period of the registration procedure is 210 working days. This period does not include the time required for conduction of a clinical study.

Stages of active pharmaceutical ingredient (API) registration, time-frames and costs.

The active pharmaceutical ingredients (API) can be approved for use (registered) in the territory of the Russian Federation in the following two ways:


  1. As part of registration of a finished pharmaceutical product for which this API will be used. 

If the manufacturer intends to supply the API to a specific plant only, then information is provided and API quality evaluation is performed as part of the finished pharmaceutical product registration procedure. In this case, the API may only be used for the pharmaceutical product so evaluated.

  1. Registration of an active pharmaceutical ingredients (API) not used in drug manufacturing. If the manufacturer has no decision to which plants he will supply his product and is going to expand the scope of his market, he is entitled to apply for registration of a API not used in drug manufacturing.

The API will be included in the State Register of registered medicinal products under a separate number.

Stages of registration of an active pharmaceutical ingredients (API) not used in drug manufacturing

Registration of a active pharmaceutical ingredient (API) consists of 2 stages:

  1. API evaluation (quality control and approval of a Normative document (specification and analytical procedures));

  2. Entering an API in the State Register of medicinal products.

The period of registration of a active pharmaceutical ingredients (API) not used in drug manufacturing: 5-7 months.

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俄罗斯EAC认证中心

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电话:021-36411293       

地址:中国上海浦东新区高科东路777号1号楼2017  

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skype: gostchina   

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