Overview

As the world’s best pharmaceutical manufacturing powerhouse, China offers a good deal of business opportunities for pharma manufacturers. Not only the Chinese pharmaceuticals have seen a rise in FDA approvals for generic medication, but also the market seems ambitious with a focus on innovation and homegrown research and development. To enter the Chinese pharmaceutical market, one needs to obtain approvals from the National Medical Products Administration (NMPA) (formerly known as China Food and Drug Administration [CFDA]), the agency which regulates food, drugs, and medical devices in the region. Medicinal products in China are classified into:

  • Chemical Drugs (small molecules)
    • Total 6 classes
    • 2 classes related to NCE (marketed outside China, not marketed globally)
  • Biological Products (15 classes)
  • Traditional Chinese Medicine (9 classes)

Get complete document list for China Get Timelines for approval in China

With proven Regulatory affairs consulting, Freyr assists manufacturers right from market strategy to dossier submissions; dossier compilation to the NMPA registration to reduce the drug’s time to market. Freyr's Regulatory services span across:

Freyr Expertise

Regulatory Intelligence

  • Regulatory Process- Governing Bodies and Regulations
  • Registration Category, Application Type and Classification
  • Registration/Dossiers/Study Requirements
  • Labeling Requirements
  • Ongoing Tracking of Ingredient-level - Safety & Scientific information
  • Import Drug Requirements
  • GxP Requirements
  • Clinical Trial Requirements

Business Strategy and Regulatory Market Consultation

  • End-to-end Regulatory Support for the Product Registration till Approval from NMPA
  • Support for Translation Services
  • Local Representative support/Support with Pre-application Meeting with NMPA/Liaison with HA until Approval
  • Pre-submission Meetings or Scientific Advice
  • Past history and Pattern of Regulatory Approvals, Re-calls and Rejections for Respective Products for Market

Clinical Support

  • Site Inspection
  • Clinical Trial Application- Preparation and Translation
  • Design and Review Clinical Trial Protocols
  • Review as per EC Guidelines
  • SOP and Guidelines for Clinical Study
  • Clinical Trail Auditing and QA
  • GLP Application Support
  • Self-inspection Report Review and Gap Analysis
  • Data Management and Statistical Analysis

Clinical/Non-Clinical Writing and PV

  • Protocol Writing
  • GLP Writing Support for CTA
  • Standard Operating Procedures Catalog (including SOP Formulation, Modification, Abandoned SOP and SOP Title)
  • Clinical Study Report Writing
  • Development of Safety Database and Management
  • Literature Monitoring
  • Post Market Approval Services-Periodic Safety Reports, Benefit Risk Reports (PBRER’s, PSUR’s)

Regulatory Affairs

  • Gap Analysis & Remediation
  • Centralized Dossier Preparation
  • CMC
  • Optimization of the Data for Submission
  • Compilation and Submission to Agency
  • Drug Registration- All Types and Classes
  • License Renewal
  • Labeling and Artwork Support
  • Templates for Safety Reports, Warning Letters

To know more about NMPA’s drug regulations and the local Regulatory assistance, reach us at sales@freyrsolutions.com