Our Wins are Yours: Successful Regulatory Submissions in China

PHDS has extensive experience preparing all major regulatory submissions to the NMPA (formerly CFDA) and/or NHC (formerly 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.	Biologicals		2.	Biological
3.	Natural Herbs		3.	Natural Herbs
4.	OTC		4.	OTC
III. Packaging Materials DMF Application			IV. API DMF Application
1.	Imported Pharmaceutical Packaging Materials		1.	Imported API
2.	Domestic Pharmaceutical Packaging Materials		2.	Domestic API
V. Pharmaceutical Excipient DMF Application			VI. Medical Device Registration
1.	Imported pharmaceutical excipient		1.	Imported Medical Device
2.	Domestic pharmaceutical excipient		2.	Domestic Medical Device
VII. Functional Health Food Registration			VIII. Novel Food Ingredient Registration
1.	Imported Functional Health Food Registration		1.	Imported Novel Food Registration
2.	Domestic Functional Health Food Registration		2.	Domestic Novel Food Registration
IX. Food Additives Registration			X. Disinfectant and Sanitizer Registration
1.	Imported Food Additives Registration		1.	Imported Disinfectant and Sanitizer Registration
2.	Domestic Food Additives Registration		2.	Domestic Disinfectant and Sanitizer Registration
XI. Cosmetics Registration			XII.		Post-market continuous monitoring of adverse drug reactions Product Registry, continuous monitoring, report writing and submission
1.		Imported Cosmetics Registration
2.		Domestic Cosmetics Registration

 

REGISTRATION SERVICE

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 NMPA (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 →

NMPA Review →

Clinical Trials Approval by NMPA →

Clinical Trials →

NMPA 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 →

NMPA Approval: Import Health Food License obtained