Regulatory Submission & Management

Our Wins are Yours: Successful Regulatory Submissions in China

PHDS has extensive experience preparing all major regulatory submissions to SFDA or MOH in China. Our regulatory project management oversight covers quality control review of each submission for verification of compliance with applicable guidelines and for potential refusal-to-file issues. As part of our client's project team, PHDS helps it meet objectives and successfully maintain applications.

I. Import Drug Registration

II. Domestic New Drug Registration

 

1.

Chemicals

 

1.

Chemicals

2.

Biological

2.

Biological

3.

Natural Herbs

3.

Natural Herbs

4.

OTC

4.

OTC

III. Pharmaceutical Packaging Registration

IV. Pharmaceutical Ingredient Registration

 

1.

Imported Pharmaceutical Packaging Registration

 

1.

Imported Pharmaceutical Ingredient Registration

2.

Domestic Pharmaceutical Packaging Registration

2.

Domestic Pharmaceutical Ingredient Registration

V. Medical Device Registration

VI. Functional Food Registration

 

1.

Imported Medical Device

 

1.

Imported Functional Food Registration

2.

Domestic Medical Device

2.

Domestic Functional Food Registration

VII. Novel Food Registration

VIII. Food Additives Registration

 

1.

Imported Novel Food Registration

 

1.

Imported Food Additives Registration

2.

Domestic Novel Food Registration

2.

Domestic Food Additives Registration

IX. Drinking Water Device Registration

X. Disinfectant and Sanitizer Registration

 

1.

Imported Drinking Water Device Registration

 

1.

Imported Disinfectant and Sanitizer Registration

2.

Domestic Drinking Water Device Registration

2.

Domestic Disinfectant and Sanitizer Registration

XI. Cosmetics Registration

XII.

Drug Registration Renewal (Re-registration) and Supplementary Application

 

1.

Imported Cosmetics Registration

 

2.

Domestic Cosmetics Registration

The Registration Services of PHDS

1. Service of Technical Guarantee

1.1 To review and verify whether the technical information is complete, sufficient and scientific (Critical Appraisal);

1.2 To review and verify whether the technical information qualifies the technical requirements of SFDA (Gap Analysis);

1.3 To provide solution for incompetent technical information (Supply Solution);

1.4 To supplement studies for the deficiency of crucial studies data.

2. Service of Compiling Application Dossiers

2.1 To provide detailed explanation on application dossiers;

2.2 To provide guidance and templates for certificates or official dossiers obtaining;

2.3 To compile the dossiers for Item 3, 4, 7, 17 and 28;

2.4 To compile the study planning, protocol, investigator’s brochure, etc. associated with the clinical trial in China;

3. Submission Management

3.1 To apply for registration and submit application dossiers;

3.2 To keep timely communication and coordination with assessment reviewers and officials, respond to their queries and questions, and provide target driving solutions for successful approval.

3.3 To manage sample test, from sample needs calculation, sample clearance at customs and sample delivery to facilitation of communication and coordination, for a successful outcome.   

Registration Process

Import Drug Registration Process

1.  Preparation

Meetings and Communication →

Contract Endorsement →

Contract Effectiveness →

Preparation for Application Dossiers →

Pre-Review of Application Dossiers

2.  In Progress

Application Submission →

Sample Test →

SFDA Review →

Approval Letter for Clinical Trials by SFDA →

Clinical Trials →

SFDA Approval: Import Drug License Obtained

Import Health Food Registration Process

1.  Preparation

Meetings and Communication →

Contract Endorsement →

Contract Effectiveness →

Preparation for Application Dossiers →

Pre-Review of Application Dossiers

2.  In Progress

Tests for Registration →

Quality Test →

Application Dossiers Submission →

SFDA Approval: Import Health Food License Obtained