PDF 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

Encourage Innovations and Genetic Drugs

? Generic drug consistency evaluation

? MAH (Marketing Authorization Holder) System

? NDA in parallel with other countries without CPP

Optimize Clinical Trial Process

IND Phase 1 Quality

Site IEC

In the Past

8-12 months

Only after foreign region has phase 1 data. Clean the IND/NDA backlog by quality inspections. GCP site accreditation Each site has its EC.

New Policy

60 Working Day notice period. Parallel early phase in China

Legal actions against fake data

Online Registration (Future) Regional EC / Central EC (Future)

Accelerate new Drug Approval

In the Past

Unmet

urgent need

NA

Rare

Disease

NA

Approval on Foreign China study for NDA registration Data purpose.

New Policy

Conditional approval on early clinical evidence

Issue China rare disease list, priority review and approval

Guideline on MRCT data acceptance, NDA approval based on MRCT result.

MAH: Marketing Authorization Holder

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

CPP: Certificate of a pharmaceutical product.

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Clear IND/NDA Backlog and Inspection on Quality

25000 20000 15000 10000

5000

18500

22000

CFDA reducing backlog

9746

11286

14235

From 22,000 cases

12068

Backlog Finished

(mid-Year2015) to 4,000 (Year 2017)

9601

9680

8200

4783

5510

4660

5261

4000

0 2011

2012

2013

Inspection on Quality

2014

2015

22Jul2015

2016

? 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? 65% application withdrawn by sponsor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

2017

146, 7% 258, 13%

313, 15%

1316, 65%

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

Sponsor Withdraw Inspected Waiver to Clinical Trial Will Inspect

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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)

? 252,600 doses DPT (diphtheria, whooping cough and tetanus), plus rabies vaccine couldn't meet the standard of immunity results

? 18 suspects were detained ? 7 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 HealthTM use only

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