Hello, welcome to Tosun!
会员中心
桐晖药业是一家为医药研究提供专业服务的CRO公司
Service Items OUR SERVICE

Other registered agents

In China, we can also provide you with registered agent services in medicine, medical equipment, cosmetics, and health food. 



Packaging Materials Filing


1. Legal basis

Article 52 of the Drug Administration Law of the People's Republic of China, Article 44 of the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and Measures for the Administration of Packaging Materials and Containers Directly in Contact with Drugs.


2. Validity of registration certificate

The Validation Period for the Registration of Pharmaceutical Packaging Materials or the Registration Certificate for Imported Pharmaceutical Packaging Materials issued by the State Food and Drug Administration is 5 years. If the validity period expires and production or import is required, the applicant shall apply for re-registration 6 months before the expiration of the validity period.


3. Applicant qualification

The domestic applicant shall be a legally registered drug packaging material production enterprise in China.


Overseas applicants should be manufacturers of overseas pharmaceutical packaging materials. The application for registration of an import declaration by an overseas applicant shall be handled by its office in China or by a domestic agency entrusted by it.


4. Implementation of the registration and management of pharmaceutical packaging materials catalogue

Infusion bottle (bag, film and accessories); ampoule; medicinal (injectable, oral or topical) bottle (tube, lid); medicinal rubber stopper; medicinal prefilled syringe; medicinal eye drops (nose, ear) Drug bottle (tube); medicinal hard film (membrane); medicinal aluminum foil; medicinal ointment tube (box); medicinal spray (gas) aerosol pump (valve, can, tube); medicinal desiccant.


5. other

China implements the registration certificate management for pharmaceutical packaging materials, that is, it needs to carry out relevant technical review. After passing the certificate, it will issue the “Registration Certificate for Pharmaceutical Packaging Materials” or the “Registration Certificate for Imported Pharmaceutical Packaging Materials”.


6. the service content

Registration of imported and domestic pharmaceutical packaging materials; re-registration of imported and domestic pharmaceutical packaging materials; application for supplementation of imported and domestic pharmaceutical packaging materials.




Veterinary Drugs Registration


1. Legal jurisdiction

Veterinary Drug Research and Registration Regulations and related requirements, including: Veterinary Drug Administration Regulations (Order No. 404 of the State Council), Registration of Veterinary Drugs (Organization of Agriculture Order No. 44), Management of New Veterinary Drugs (Organization of Agriculture Order No. 55), Veterinary Medicine Measures for the Administration of Imports (Order No. 2 of the Ministry of Agriculture), Announcement No. 442 of the Ministry of Agriculture (Requirements for Registration of Veterinary Drugs), Bulletin No. 446 of the Ministry of Agriculture, Administration of Approval Numbers for Veterinary Drug Products (Organization Order No. 45), Veterinary Drugs Research technical specifications, veterinary drug research technical guidelines.


2. Classification of registration methods

2.1 Registration and import registration of new veterinary drugs;

2.2 Change registration;

2.3 Import re-registration;

2.4 Apply for the national standard veterinary drug approval number.


3. Who to apply to

3.1 New veterinary drugs (biological products), imported veterinary drugs: apply for clinical and registration certificates, apply to the Veterinary Bureau of the Ministry of Agriculture, and be examined and approved by the Veterinary Bureau of the Ministry of Agriculture.

Other new veterinary drugs (Chinese medicine, chemical medicine): Apply for clinical application to the Provincial Veterinary Bureau, and be approved by the Provincial Veterinary Bureau; apply for a registration certificate and apply to the Provincial Veterinary Bureau for approval by the Provincial Veterinary Bureau.

3.2 Change registration and import re-registration: Apply to the Veterinary Bureau of the Ministry of Agriculture for approval by the Veterinary Bureau of the Ministry of Agriculture.

3.3 Apply for the national standard veterinary drug approval number: biological products, apply to the Veterinary Bureau of the Ministry of Agriculture, and be examined and approved by the Veterinary Bureau of the Ministry of Agriculture; other veterinary drugs (Chinese medicine, chemical medicine), apply to the Provincial Veterinary Bureau, reported by the Provincial Veterinary Bureau Approval by the Ministry of Agriculture Veterinary Bureau.




Cosmetics Filing/Registration


1. background introduction

In the global cosmetics sales ranking, China ranks third after Japan and the United States. With the upgrading of China's economic structure, the cosmetics market has broad prospects.

Chinese regulations mandate that cosmetics that are marketed in China must go through the filing or administrative licensing procedures at the relevant CFDA authorities.

Because pharmaceuticals and health foods have a relatively long time to obtain marketing approvals in China, and cosmetics can be legally listed in China in a relatively short period of time, cosmetics have become a foreign production company, domestic and foreign trading companies, etc. Preferred for companies in the Chinese marketHealth products.

According to the requirements of the regulations, imported non-special-purpose cosmetics entering the Chinese market must be completed in the drug supervision department, and obtain the “Imported Non-Special Purpose Cosmetics Voucher”; the imported special-purpose cosmetics must be completed in the drug supervision department and obtain the administrative license application. Import special use Cosmetics Administrative License Approval.


2. Project objectives

The goal of this project is to help customers obtain the registration documents for importing non-special purpose cosmetics or the administrative license for importing special-purpose cosmetics.


3. Second, the project process

3.1 Reporting responsible units in China for filing (imported cosmetics)

3.2 Prepare application sample inspection materials

3.3 Determine the testing mechanism and send samples for inspection

3.4 Preparation of application for cosmetic filing/administrative licensing application materials

3.5 Submit application for cosmetic filing/administrative license application materials

3.6 Obtained the import voucher/administrative license for non-special use cosmetics




Health Food Registration


Project introduction

Health food registration means that the State Food and Drug Administration, according to the application of the health food registration applicant, conducts a system for the safety, effectiveness and quality controllability of the health food to be marketed and the contents of the label specification in accordance with legal procedures. Evaluation and review, and decide whether to approve the approval process for its registration, including the approval of product registration applications, change applications, and technology transfer product registration applications.


The application for registration of domestic health food refers to the application for registration of the applicant to produce and sell health food in China. Health foods should be produced in workshops that comply with the Good Manufacturing Practices for Health Foods, and the processing must comply with the requirements of the Good Manufacturing Practices for Health Foods.


Imports (including Hong Kong, Macao and Taiwan) applications for health food registration refer to applications for registration of health food products that have been produced and sold outside China for more than one year. If an overseas manufacturer does not have a legal office in China, it must entrust a professional agency in China to register.


热门关键词: 进口原料药代理 印度进口原料药 原料药关联审评 进口药品注册代理 国内参比制剂 美国参比制剂 原料药注册服务 原料药联合申报 原料药供应商
Copyright ©2020 Guangzhou Tosun Pharmaceutical Ltd 粤ICP备16102594号-2
MapsXML Maps  Maps
Phone

(86)18922121079

(86)18026299762

TOP