Transcript EFPIA`s view on regulatory reform in China, Jin Shun, Vice chair

China EU Pharmaceutical Forum
Author: Shun Jin Date: 05/Apr/2016 Version: 1.0
EFPIA’s view on China
regulatory reform
www.efpia.eu
Agenda
• Overview of the reform for the drug review and
approval system
• Major regulatory updates since 2015
• Positive aspects of recent regulatory updates
• Areas requiring clarification and improvement
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Overview of the Reform for the drug review and
approval system
Major goals
Encourage the R&D of innovative drugs
Improve the quality of review and approval
Aug 18 2015
Resolve registration backlog
With the aim of improving drug
safety and quality and
encouraging innovation
Enhance the transparency of review and
approval
Improve the quality of generic drugs
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Major regulatory updates since 2015 (1)
• Announcement on Promulgating the Guidance for
International Multicenter Clinical Trials (IMCT) (Trial
Implementation) - Jan 2015
Research and
development
• Guidance on the Research and Development of
Biosimilars (Trial for Implementation) - Feb 2015
• Regulations for the Administration of Human Genetic
Resources - Jul 2015 (draft)/ Oct 2015 (implemented)
• Working Plan for the MAH Pilot Program (Draft for
Comments) - Nov 2015
• Guidelines on Clinical Trials for Use of Drugs in
Pediatric Population - Mar 2016
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Major regulatory updates since 2015 (2)
• Raised registration fee - May 2015
• Streamlined administration and delegation of power to lower-level
governments - Jun 2015 (CFDA opinion) / Mar 2016 (State Council decision)
• Clinical trial data inspection - Since Jul 2015
• Review and approval of new excipients/ new immediate container linked to the
review and approval of new drug products - Aug 2015 (State Council opinion),
Jan 2016 (draft dossier requirements for comments)
• New registration categories for chemical drugs - Nov 2015 (draft)/ Mar 2016
(final)
• Priority review and approval - Nov 2015 (draft)/ Feb 2016 (final)
• BE study: changed from approval to notification - Dec 2015
• The Administrative Measures for the Communication and Exchange of Drug
Technical Evaluation (for Trial Implementation) Dec 2015 (draft)
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Major regulatory updates since 2015 (3)
Manufacturing
• ChP 2015 implementation - since Dec 2015
Post-marketing
• Consistency evaluation on generic drugs - 2012
(started)/ Nov 2015 (draft)/ Feb 2016 (final)
• Guidance on the Reporting and Monitoring of
Adverse Drug Reactions (Trial for Implementation) Jul 2015
• Drug traceability system suspended - Feb 2016
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Positive aspects of recent regulatory updates (1)
• Encouraged research and development of innovative drugs
- Improve clinical trial approval and review should focus on clinical value and
subject protection
- Accelerate the review and approval process for drugs with urgent clinical
demand
- Optimization of the priority review and approval system
- Strengthened communication and supervision during review and after CTA
approval
China self-developed Enterovirus Type 71 Vaccine,
Inactivated (Human Diploid cell), approved
through Special Review Procedure in Dec 2015
JK-05: China self-developed recombinant Ebola
vaccine, CTA approved through Special Review
Procedure in 2015
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Positive aspects of recent regulatory updates (2)
• Expected improvements in drug quality and availability
- Accelerated review and approval of drugs satisfying highly unmet clinical
need
- Encouraged development and manufacturing of drugs in shortage
- Encourage pediatric drugs development and speed up the review/approval
process.
Alglucosidase Alfa for Injection: an orphan drug
for Pompe disease, approved in Oct 2015
Pasireotide Diaspartate Injection: an orphan drug for
Cushing’s disease, approved in May 2015
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Positive aspects of recent regulatory updates (3)
• Improved drug review process and increased review efficiency
- Seriously investigate and punish fraudulent activities of registration
application
- Intention to improve CDE review quality control system (GRP)
- Hire of additional review resources
- One-time approval of different phases of clinical trials for locally
developed innovative drugs
- Notification of BE studies for generic applications
- Simplification of procedures for technical transfer between local drug
manufacturers
• Increased transparency of review and approval process
- Encouraged communication between applicants and regulatory
agencies
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Positive aspects of recent regulatory updates (4)
• Reduced backlog of drug registration applications
- Implement centralized review for the backlogged applications
- Non-approval of registration renewal for drugs which have not been
marketed within the validity period of the license
12000
9601
10000
8868
8211
8000
6000
Accepted new registration applications
Review tasks completed by CDE
5261
4000
2000
0
2014
2015
* CDE annual report 2015
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Positive aspects of recent regulatory updates (5)
• Expected improvement in clinical trial data integrity
- Strengthened supervision over clinical trials
- Severe punishment on fraudulent activities
- Temporary procedure of clinical trial data inspection
• Greater clarity on clinical trial requirements
- Guidelines on Clinical Trials for Use of Drugs in Pediatric
Population
- Guidance on the Research and Development of Biosimilars
(Trial for Implementation)
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Positive aspects of recent regulatory updates (6)
• Expected improvement in the quality of generic drugs
- Reinforce the equivalence evaluation of generic products
(comparing with innovative drug)
- Control low-level applications (release the catalogues of
drugs restricted for approval)
- Improved supervision through frequent unannounced
inspections
• Guidance on generic applications
- Strict control on the manufacturing and approval of generic
drugs which are developed with outdated manufacturing
process and have been over-supplied
- Publication of generic drugs for which approval is restricted
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Areas requiring clarification (1)
• Priority review and approval
- Connection to the existing Special Review Procedure
- Details about the pediatric clinical data
waiver/extrapolation requirements
- Implementation details
- Review timeline
• Biosimilars
- Sourcing of reference products outside China
- Manufacturing process and analytical procedures of
reference products
- Number of batches for the comparability exercise
- Indication extrapolation
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Areas requiring clarification (2)
• Implementation of ChP 2015
- Availability of the official English translation and relevant
materials
• Excipient requirements for imported products
• Delegation of power to lower-level governments
- Need more clarity on the list of supplementary applications
that can be approved by provincial FDA
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Areas need improvement
• MAH pilot program
- Participation of foreign innovative drug manufacturers
• Consider different dossier requirements for CTA/NDA
applications
• Alignments with internationally recognized pharmacopoeias
especially for excipient and packaging materials
• Implementation window and implementation details
• Human genetic resource management
- Additional review/approval step before the new drug clinical
trial can start
- Prolonged clinical trial execution and finalization timeline
- Delayed access of Chinese patients to innovative drugs
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Summary
EFPIA appreciate the efforts by CFDA to better shape the current
regulatory system
Positive trend has been captured with encouraging
improvement
Further clarification and development is still needed
EFPIA is willing to support regulatory reform in Chinese market
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Thanks
EFPIA Brussels Office
Leopold Plaza Building * Rue du Trône 108
B-1050 Brussels * Belgium
Tel: + 32 (0)2 626 25 55
www.efpia.eu * [email protected]