Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

China Approves Drug Marketing Authorization Holder Pilot Plan, Impacting CMOs

By Business Wire | June 20, 2016

China’s State Council issued an effective notice dated May 26, 2016, formally authorizing a trial plan for a new Drug Marketing Authorization Holder (MAH) System for ten provinces: Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong, and Sichuan. Pharmaceutical research institutions and individual researchers in these provinces can submit application for clinical trials or Marketing Authorization registration. Applicants obtaining marketing authorizations and approval documents can become MAHs and take legal responsibility for clinical trials, production and marketing, something previously not allowed.

According to PaizaBio’s David Deere, who oversees the company’s aesptic fill/finish operations in China, this is significant as it approves the use of contract manufacturing organizations (CMOs) to produce drugs in China. Per the State Council’s announcement, MAHs without manufacturing capabilities for production must contract with a CMO with qualification to produce approved drugs. MAHs with manufacturing capabilities can use their own facility to produce drugs or may contract production with qualified CMOs. MAHs or applicants can submit additional information, alternate MAH, and change CMO during and after the approval process.

The announcement is a clarification of policy reforms announced by China’s Food and Drug Administration (cFDA) in late 2015 designed to accelerate the regulatory review of new drugs and expand options for manufacturing approved drugs. The new policies, which went into effect December 1, 2015, represent major changes in China’s drug development and commercialization policies and address the high-volume backlog of drugs awaiting review and approval by the cFDA and foster domestic clinical drug development and manufacturing to international technical and quality standards. Chinese and Western pharmaceutical companies are impacted.

Drugs qualified for MAH trials include:

  • Therapeutic biologics class 1 – biologics that have not been marketed outside or inside China.
  • Therapeutic biologics class 7 – biologics that have been marketed outside China but not inside China
  • Biosimilars
  • Traditional Chinese Medicine and natural drug classes 1-6
  • Chemical drug classes 1-4
  • Chemical drug class 5 – Drug preparations that change the formulation of marketed drugs without changing administration route.
  • Chemical drug classes after new chemical registration classification system is enforced (date to be determined).
  • Approved generic drugs that have quality and efficacy consistency to original drugs. Including chemical drug classes 3-4 after the new chemical registration classification.
    • Domestic drugs (i) referencing originator drugs that are marketed outside of China, not in China yet, and (ii) consistent with the originator drugs in quality and efficacy.
    • Domestic drugs (i) referencing originator drugs that are already marketed in China, and (ii) consistent with the originator drugs in quality and efficacy

The MAH Trial period takes effect on this date of plan issuance until November 4, 2018 at which time participants’ approval documents will remain valid for the full approval period as issued. See full release for details on qualified drugs.

Source: Chinese FDA.

Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!


Filed Under: Drug Discovery

 

Related Articles Read More >

Korean team reports all-in-one cancer nanomedicine in pre-clinical studies
Nektar’s Phase 2b atopic dermatitis win triggers 1,746% analyst target surge, but legal tussle with ex-partner Lilly could complicate path forward
Dupixent approved to treat bullous pemphigoid
EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE