Recent Regulatory Changes in China and Impacts to the ...

Recent Regulatory Changes in China

and Impacts to the Clinical Trials

from CRO Standpoint

China New Regulatory

New Drug Approval System Reform

The State Council

08Oct2017

Optimize Clinical Trial Process

In the Past

IND

Encourage

Innovations and

Genetic Drugs

Phase 1

Quality

Site

?

Generic drug consistency

evaluation

?

MAH (Marketing Authorization

Holder) System

?

NDA in parallel with other

countries without CPP

New Policy

8-12 months

60 Working Day notice period.

Only after foreign region has

phase 1 data.

Parallel early phase in China

Clean the IND/NDA backlog by

quality inspections.

Legal actions against fake data

GCP site accreditation

Each site has its EC.

Online Registration (Future)

Regional EC / Central EC (Future)

IEC

Accelerate new Drug Approval

In the Past

Unmet

urgent need

Rare

Disease

New Policy

NA

Conditional approval on early

clinical evidence

NA

Issue China rare disease list,

priority review and approval

Approval on

Foreign

China study for NDA registration

Data

purpose.

? 2018 All rights reserved | Confidential | For Syneos Health? use only

Guideline on MRCT data

acceptance, NDA approval based

on MRCT result.

MAH: Marketing Authorization Holder

CPP: Certificate of a pharmaceutical product.

4

Clear IND/NDA Backlog and Inspection on Quality

25000

CFDA reducing

backlog

22000

20000

18500

15000

14235

10000

Backlog

12068

11286

Finished

9746

From 22,000 cases

(mid-Year2015) to

4,000 (Year 2017)

9680

9601

8200

5000

4783

5510

4660

5261

4000

0

2011

2012

2013

2014

2015

22Jul2015

2016

2017

Inspection on Quality

? 22Jul2015: CFDA announced to have on site

inspections

? Two years after till Jul2017

? 65% application withdrawn by sponsor

? Finished inspections on 313 NDA applications

? 185 inspection team (1635 person-time)

? 763 site-time

146,

7%

Sponsor Withdraw

258, 13%

Inspected

313, 15%

1316, 65%

Waiver to Clinical Trial

Will Inspect

? 2018 All rights reserved | Confidential | For Syneos Health? use only

5

Legal Actions Against Clinical Trial and Marketed

?

?

Legal actions in case of fraudulent activities (Year 2015-2017 Summary)

?

Finished inspections on 313 NDA applications

?

38 NDA may have the fake data, 30 NDA were rejected

?

Legal actions against to 11 sites and CROs

China sacked top officials over vaccine scandal (Jul-Aug 2018)

¨C

252,600 doses DPT (diphtheria, whooping cough and tetanus), plus rabies vaccine

couldn¡¯t meet the standard of immunity results

¨C 18

¨C7

suspects were detained

senior government officials were punished

?

Bi Jingquan, former CFDA head resigned

?

Wu Zhen, one NMPA former deputy head, was investigated on anti-corruption

?

Two deputy governors of Jilin Province were dismissed or resigned

? 2018 All rights reserved | Confidential | For Syneos Health? use only

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