技术转让

诺孚泰制剂技术转让和欧洲批文转让服务介绍
Introduction of Tech transfer and MA transfer

诺孚泰制剂技术转让和欧洲批文转让服务介绍

Introduction of Tech transfer and MA transfer

 

1. 关于我们 ABOUT US

广州安信已在中国进行原料药注册及分销接近10年,企业数据库覆盖逾400家客户,经验丰富。着眼于客户需求,2017年,安信成立子公司广州诺孚泰医药科技有限公司,为客户提供制剂相关的服务,包括制剂引进、技术引进、咨询及注册服务。

Guangzhou Greensyn have been engaged in registration and distribution of API for nearly 10 years in China. Which cooperates to more than 400 clients with rich experience. Greensyn Lifescience Co., Ltd, as one subsidiary of Greensyn is established in 2017, its major business to provide FDF services related to FDF Licensing-in, FDF tech-transfer and, consultation and registration services.

 

 

2. 背景 Background

2016年,国家食品药品监督管理局(CFDA)转发国务院发布的《关于开展仿制药质量和疗效一致性评价的意见》,仿制药一致性评价正式拉开大幕。通知要求2018年底前,289种成品剂量必须通过仿制药质量一致性评估。

In 2016, CFDA announced Opinions on the Quality and Efficacy Consistency Evaluation of Generic Drugs, which requires that there are 289 kinds generic drugs have to attach the standard of the quality and efficacy consistency evaluation before end of 2018.

 

2018年7月10日,国家药品监督管理局发布了《接受药品境外临床试验数据的技术指导原则》的通告(2018年第52号)。该指导原则所涉及的境外临床试验数据,包括申请人通过创新药的境内外同步研发在境外获得的临床试验数据,以及具备完整可评价的生物等效性数据的在境外开展仿制药研发。

就目前情况看来,国家法规开始认可接受国外的临床数据,这将对从国外引进优质的制剂和技术产生非常积极的影响。

On July 10, 2018, the CFDA issued the notice Technical Guidelines for Accepting Data from Clinical Trials Outside the Territory of Drugs (no. 52 of 2018). The guideline covers overseas clinical trial data, including the clinical trial data obtained by the applicant through synchronous research and development of innovative drugs in and out of China, and the research and development of generic drugs in foreign countries with complete and evaluable bioequivalence data.

it is a good time for domestic pharmaceuticals companies to license generic drugs and/or transfer formulations from foreign supplier during this special period.

 

 

3. 合作优势 Advantages

1) 诺孚泰的国际资源丰富。目前,我们已经和国外超过40家优秀药企进行了长期的合作,能提供超过150个品种的制剂技术,对应超过30种适应症。

Supporting by huge and various international pharmaceutical companies, Greensyn are available a lot of high quality FDF to meet the need of domestic customers. So far, Greensyn Lifescience has cooperated to more than 40 excellent pharmaceutical companies abroad, among more than 150 kinds of FDF with mature technology, referring to more than 30 therapeutic fields.

 

2) 技术资料包括完整的CMC资料和正式的生物等效数据,同时还包括商业批次生产的相关数据及记录,转移技术时可以进行有效的数据重现,减少研发资金和时间成本的投入并快速完成技术落地。

FDF dossier including complete CMC materials, formal BE data, related date and report of business batch manufacture, could be effectively reproduce technology, which reduces the cost of development and saves time, and could finish tech transfer quickly.

 

3) 同时,供应商还会根据客户的需要进行线上或现场的技术指导,这能极大程度的保证技术落地

Supplies will provide technical support with on-site and/or on-line assistance to help customers until success to tech transfer.

 

4) 结合技术提供方的经验,还能有效帮助客户生产场地快速获得欧洲GMP资质,提高整体质量,为走国际化道路作铺垫
Clients’ manufacture site could be rapidly approved by EU GMP qualification under foreign supplies’ support with mature development experience. It is helpful for domestic customers to explore international market.

 

4. 合作附加价值 Package Service

1) 开展技术引进合作,客户可根据需要购买欧洲上市批文,用以触发GMP审计或在上市地进行销售;
Customers could purchase EU MA by supplier if need, to sale drug in territory 

2) 安信旗下子公司还可提供以下服务:
Greensyn and its other subsidiary also provide following service to our clients:

a) 国外优质API的中国稳定供货 High-quality API supply to domestic customers.

b) 辅助进行API、药用辅料及药用包材的备案。Assist to file API, excipients and medical packaging materials.

c) 中国及欧美法规咨询服务等。
consult Law and Regulation referring to drug registration and other related business at home and aboard.


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