Download An Overview: New Drug Registration System and Approval Process

An Overview: New Drug Registration
System and Approval Process in China
James S. Yan, PhD, MD, DABT
Sr. Director and Site Scientific Lead
Covance Pharmaceutical R&D (Shanghai) Co. Ltd.
CONFIDENTIAL
China Pharma Market
2012 Parma Market:
Global – 1 trillion US$
China - ~150 billion US$
• China Pharma Market currently is the third largest market in the world
• It is estimated that it will be the 2nd(in 2015) and 1st (2020) largest market
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Presentation Outlines
• China drug regulation laws and policies
• The China Food and Drug Administration (CFDA)
– Structure
– Main responsibilities
• The new drug registration in China
– Drug classification
– Requirements
– Procedures
• The latest changes and updates of China regulations for
new drug registration
• How Covance can help our clients achieve a successful
application of their drug registration in China
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Poll #1
How familiar are you with the drug registration
system and approval process in China?
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Not at all familiar
Slightly familiar
Moderately familiar
Very familiar
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Drug Laws, Regulations and Policies
• Three key drug laws and regulations
– Drug Administration Law of the People’s Republic of China
(Dec. 01, 2001)
– Regulations for Implementation of Drug Administration Law of the
People’s Republic of China (Sept. 15, 2002)
– Regulations on Administrative Protection for Pharmaceuticals
(Jan. 31, 1993)
• Drug regulation policies
– Provisions for Drug Registration (July 10, 2007)
– Special Review and Approval Procedure for Drug Registration
(Nov. 18, 2005), revised in 2009
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China Food and Drug Administration (CFDA)
The State Food and Drug Administration (SFDA)
2003 - 2013
The China Food and Drug Administration (CFDA)
2013 –
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China Food and Drug Administration (CFDA)
Seven Major Affiliates of CFDA
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China Food and Drug Administration (CFDA)
• Main responsibilities
– The implementation and enforcement of
pharmaceutical rules and laws
– Regulations for all drug, food, supplement, medical
device, and cosmetics in China
– The inspection, sales, research, and advertisement of
drug, food, supplement, medical device, and
cosmetics products
– Drug approvals
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The New Drug Registration Process
• Drug Classification in China
– Chemical Drugs (small molecules):
• Total 6 Classes
• 2 classes are related to NCE
– Class 1: NCEs that have not been marketed in the world,
– Class 3: NCEs which marketed in outside China
– Biological Products:
• Total 15 Classes and all are considered as new drug
– Class 1: New biologics
– Class 2: Monoclonal Antibody
– Class 3: Gene therapy and cell therapy
– Traditional Chinese Medicines (TCM)
• Total 9 classes
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The New Drug Registration Process
• The Types of Drug Application/Registration
in China
– New drug
• Classes 1 and 3 chemical drugs
• All biologics
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Import drug: NCE and Biologics
Generic drug: Other 4 classes of chemical drugs
Dietary supplements
Drug re-registration
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The New Drug Registration Process
• The Requirements for New Drug Registration
(including Import Drug Registration)
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Overview Summary
Pharmaceutical Sciences (CMC)
Non-clinical Pharmacological and Toxicological Research
Clinical Research
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The New Drug Registration Process
• Two Application Steps
– Clinical Trial Application (CTA or IND)
– Marketing Application (NDA)
• Two Review Stages
– Provincial FDA Review:
• Dossier Content/Format Checking
• On-site Inspection
– China FDA (CFDA) Review
• Technical review by the Center for Drug Evaluation (CDE)
• Approval by CFDA
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The New Drug Registration Process
• CTA (IND) Approval Process for New Drugs
From CFDA Website: http://eng.sfda.gov.cn/WS03/CL0769/61659.html
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The New Drug Registration Process
• CTA (IND) Approval Process for Import Drugs
From CFDA Website:
http://eng.sfda.gov.cn/WS03/CL0769/61658.html
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The New Drug Registration Process
• Marketing Application (NDA) Approval Process
(for import drug)
From CFDA Website: http://eng.sfda.gov.cn/WS03/CL0769/61657.html
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The Latest Changes and Updates
Special Review and Approval for New Drug
Registration (2009)
• Active ingredients extracted from plants and animal or mineral
resources and their formulations that have never been marketed
in China.
• Active pharmaceutical ingredients (APIs) and their formulations or
biological products that have not yet been approved for domestic and
foreign markets.
• New drugs showing clear therapeutic advantages in the treatment of
AIDS, malignant tumors, and rare or orphan diseases.
• New drugs that may be used to potentially treat diseases for which no
known effective therapy is yet available.
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The Latest Changes and Updates
Special Review and Approval for New Drug
Registration (2009)
• The new regulation is intended to
– Encourage drug innovation in China
– Develop the principles of ’early involvement, priority evaluation,
multiple channel communication, and dynamic submission of
supplemental information’.
– Stipulate relevant provisions on the conditions, procedures, and
requirements of the special approval process for new drugs
– Specify rights and obligations of applicants in the special approval
process
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The Average of the Review Time
From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA
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The Review Timelines of CTA in Major TAs
From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA
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Registration Application from 2009 – 2012
Number of various registration applications
• The number of Category 1.1 (New Drug) applications was around 70
• Very small portion compared with other Categories
From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA
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The Latest Changes and Updates
Major Reforms to Drug Regulatory Process
(2013)
SFDA proposed the fast-track drug registration processes for China-based
innovation and clinical priorities and to promote the healthy development of
China’s pharmaceutical industry.
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The Latest Changes and Updates
Major Reforms to Drug Regulatory Process
(2013)
• Innovative drugs:
– Create a favorable environment for the R&D of innovative new drugs
– Accelerate technical reviews and regulatory approvals
• Generics:
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Revised national strategy for generic drugs
High clinical priority generics will receive fast-track reviews
Discourage the generic drugs which offer little clinical value
Require the clinical bioequivalence testing for all generic drugs
Generate the Chinese version of the United States' Orange Book
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The Latest Changes and Updates
Major Reforms to Drug Regulatory Process
(2013)
• Clinical trials:
– Strengthen the quality and management of pharmaceutical
clinical trials
– Independent ethics committee to evaluate the clinical trials
– Clinical trial transparency
• Pediatric drugs:
– Encourage the development of pediatric drugs through suitable
tendering and pricing and reimbursement (P&R) incentives
– Prioritize the suitable generic drugs for pediatric use with the
potential for exclusivity periods.
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Covance Laboratory
• One of the world’s largest and most comprehensive drug
development services companies with more than 11,000
employees in 60 countries.
• Services include:
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Discovery and translational services
Early development services
Clinical development services
Central laboratory services
Commercialization services
• Mission:
To help our clients bring the miracles of medicine to market sooner
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Covance China
Clinical Dev. Services
Office
• Clinical Operations
Home base
• CDARO (clinical data analysis
and reporting)
• Medical Affairs
• Drug Safety
Beijing
• Regulatory
Tianjin
• QC/QA
Xi’an
Shiyan
Wuhan
Chengdu
R&D laboratories
Changsha
• Central Laboratory Services (including
biomarkers and genomics)
Guangzhou
• Non-clinical Safety Assessment
• DMPK Services (In Vivo & In Vitro)
• Bioanalytical Services (Small and large
molecules)
• DTS (in vivo Pharmacology, PK/PD)
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Covance China: Early Development
• State of Art facilities with 90,000 square feet
• Consistency with Covance global standard
– Global operation procedures and training programs
– Common technology platforms and flexible scientific and
technical resources
• Accreditation/Regulatory Compliance
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Certificate of Chinese Quality and Animal Bureau
Full accreditation of AAALAC
Certificate of Belgium GLP with OECD GLP Principles
Certificate of China FDA (CFDA)
Compliance with US FDA GLP Practice Regulations (21CFR
Part 58)
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Covance China: Early Development
Drug Discovery
Preclinical Development
Drug
Discovery
In-Vivo
Pharmacology*
Nonclinical Safety Assessment
Lead Optimization*
Additional
Services*
PK Screening*
DMPK In-Vitro and In Vivo Study*
Non-GLP and GLP compliant studies*
Provide all services in preclinical development to
support clinical studies
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Covance China: Regulatory Services
• Regulatory Support of New Chemical Entities
– Global Regulatory Strategies
– Regulatory Support of All Phases of Clinical Development (IND/CTA, import
permits, export waivers, GCP auditing, etc.)
– CMC (Chemistry, Manufacturing, Control)
– Medical Writing
– Labeling
– Translations of Technical Documents
– Coordination of Regulatory Certificates
– Medical and Clinical Consulting
• Consulting on the Complete Product Development Program (all phases)
– Reviewing and Assessing Clinical Protocols
– Reviewing Safety and Efficacy Related Issues During Product Development
– Adjudicating Clinical Data
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Summary
• Chinese pharmaceutical industry has experienced significant growth
and will continue grow with over 20 percent annually
• In next several years, China pharmaceutical market will become the
2nd or largest in the world. Most of the pharmaceutical companies
have been expanding their footprint in efforts to enter the Chinese
drug market
• Drug registration and regulation in China is a complicated and timeconsuming process, involving a number of regulatory bodies at
various levels of central and local governments
• It is very critical for pharmaceutical companies to understand the
drug registration system in China and to know how to get the drug
approved with China pharmaceutical regulatory authority
• Covance, as the world largest and most comprehensive drug
development services company, can help to achieve the successful
application and drug registration in China
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Q and A
Thank you very much!
Contact information:
Name: James Yan
Email: [email protected]
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