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China Pharmaceutical Regulatory
Updates
Pacific Bridge Medical
January 18th 2012

www.pacificbridgemedical.com
Copyright ©...
China has become the 3rd largest pharma market
globally since 2010
China pharmaceutical market size

Top 4 pharmaceutical ...
Navigating the market in China is no easy task, as the
value chain involves a complex set of stakeholders
Illustration of ...
Various agencies and their responsibilities
 

MOH (Central ) &
Provincial Health
Bureaus

SFDA

MOHRSS
(Central &
Provinc...
A series of provisions and guidelines regulate drug
development and approval in China
Scope of Regulations
• Approval for ...
Application documents for New drug registration
•

•

The SFDA has issued a detailed documentation list for
chemical drugs...
Data requirements are itemized according to drug
classification designated by SFDA
Class 1
(Sub-classes)  

Class 2

Class...
Application and approval procedure for conducting
clinical trials in China
IND Application submitted to
Provincial Drug Ad...
For an imported new drug, it takes approx 36– 42
months from IND submission to NDA approval
Step 1:
Application for
conduc...
Drug development in China – IND approvals
IND Approvals in China
2006

2007

2008

2009

2010

New
molecules/for
mulations...
It takes up to 15 months for a brand to be prescribed
after receiving SFDA’s approval
Approval of Drug Price
4-5 months
 ...
A 5-step price-setting process for RDL drugs by
NDRC has been in place since March 2007
Step 1

Step 2

Step 3

 Regulato...
The development of the Reimbursed Drug List (RDL)
is “top-down”, without drug-makers’ participation
National RDL

• Nation...
Pricing and reimbursement dynamics - summary
 RDL is “Product” specific, not “Brand” specific
 RDL List B: mainly innova...
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2012 China Pharmaceutical Regulatory Update

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This webcast is an abbreviated version of the full-length version produced by Pacific Bridge Medical in 2012. To access the full version, visit our website at www.pacificbridgemedical.com/webcasts.

China's pharmaceutical market is currently the ninth largest worldwide and worth approximately $25 billion. With analysts predicting this market to be the fifth largest by 2013, one cannot ignore China's potential. This webcast will provide an overview of drug registration in China as well as discuss the most recent China pharmaceutical regulations issues of the Chinese State Food and Drug Administration (SFDA).

This webcast is intended for regulatory affairs professionals interested in learning more about the China Pharmaceutical Regulatory environment and how to register their products in China.

For further questions on China Pharmaceutical Regulations, how you can register your product in China, quality issues and more, Pacific Bridge Medical offers free 15 min consultations. Please contact us through our website at www.pacificbridgemedical.com/contact-us.

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2012 China Pharmaceutical Regulatory Update

  1. 1. China Pharmaceutical Regulatory Updates Pacific Bridge Medical January 18th 2012 www.pacificbridgemedical.com Copyright © 2012 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.
  2. 2. China has become the 3rd largest pharma market globally since 2010 China pharmaceutical market size Top 4 pharmaceutical markets, 2011 (Estimated) USD Bn (@ ex-factory value) 1. US $310 billion 2. Japan $102 billion 3. China $41 billion 4. Germany CAGR: 1922% (’11-’15) $40 billion CAGR: 21% (‘03-’11) Source: IMS Health, MENET China Note: IMS data tends to under-estimate China’s market Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 2
  3. 3. Navigating the market in China is no easy task, as the value chain involves a complex set of stakeholders Illustration of the business of Rx commercialization in China Approval of Approval of New Drug New Drug (RDL* &) (RDL* &) Approval of Approval of Drug Price Drug Price Tendering & Tendering & Bidding Bidding Hospital Hospital Listing Listing Physician Physician Prescribing Prescribing Dispensing Dispensing Key constituents • Drug manufacturers • Distributors • Central government: various agencies • Provincial governments: various agencies • Hospitals: various classes and levels • KOLs and physicians *: RDL – Reimbursed Drug List Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 3
  4. 4. Various agencies and their responsibilities   MOH (Central ) & Provincial Health Bureaus SFDA MOHRSS (Central & Provincial) NDRC Drug registration         GMP monitoring         Pricing & price review         Reimbursement / RDL         Essential drug list         Tendering         Clinical trial         Post-market surveillance         Level of Influence Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com Low High 4
  5. 5. A series of provisions and guidelines regulate drug development and approval in China Scope of Regulations • Approval for conducting clinical trials (IND) • Approval for new drug manufacturing • Approval for marketing license (NDA) • Registration supplements • Renewal of license Types of Drugs • New drugs • Generic drugs • Imported drugs Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 5
  6. 6. Application documents for New drug registration • • The SFDA has issued a detailed documentation list for chemical drugs, biological products, and traditional Chinese medicine The SFDA has issued technical guidance for some document sections • Adopted CTD format for submission since 2010 • If the products are imported, the SFDA will also accept drugs prepared in accordance with ICH guidelines Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 6
  7. 7. Data requirements are itemized according to drug classification designated by SFDA Class 1 (Sub-classes)   Class 2 Class 3 Class 4 Class 5 Class 6                                                                                                                   Clinical Data (incl. size of trials)     Pharmacology and Toxicology Data     Pharmaceutical Research Data (incl. CMC)       ive at tr us Ill                                                                                                                                                                                                                                           Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 7
  8. 8. Application and approval procedure for conducting clinical trials in China IND Application submitted to Provincial Drug Administration (PDA) Dossier check and possible site inspection by PDA Illustrative Review by and communications with CDE at SFDA Approval of Clinical Trial Protocol by SFDA Certificate for new drug manufacturing by SFDA Approval of Clinical Trial Protocol Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 8
  9. 9. For an imported new drug, it takes approx 36– 42 months from IND submission to NDA approval Step 1: Application for conducting clinical trials (IND Application) Step 2: Conducting clinical trials Takes 7 - 10 months (SFDA, NSCPBP) Timeline pending upon the scale of clinical development, which in turn depends on the New Drug Classification (Applicant) Takes 7 - 15 months (SFDA; NSCPBP) Step 3: Application for imported drug registration(NDA Review & Approval) Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 9
  10. 10. Drug development in China – IND approvals IND Approvals in China 2006 2007 2008 2009 2010 New molecules/for mulations (local) N/A N/A N/A 288 141 Generics (local) N/A N/A N/A 196 153 Imported drugs N/A N/A N/A 320 308 1,426 758 581 804 602 Total Anti-corruption reforms in 2006-2007 began to set more globalized standard Sources: SFDA publications Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 10
  11. 11. It takes up to 15 months for a brand to be prescribed after receiving SFDA’s approval Approval of Drug Price 4-5 months  A drug must obtain its approved retail price before entering the bidding process  If the drug is on the NRDL, its price is set by NDRC  If the drug is not on NDRL, the manufacturer must get its retail price approved by provincial government s (The Pricing Bureau)  Approx. 3 months to get price approval at the province where the company is registered  Additional 1-2 months to get price at other provinces  The process needs to be carried out at each province individually Provincial Bidding Hospital Listing 3-5 months 3-5 months  Each Province will select a few (2-5 suppliers) for each drug (molecule, dosage form, dose strength) – the bidding process  The bidding schedule s(a few times a year) are set by provincial governments  Whether or not the drug is or not on RDL, bidding process is a MUST before entering hospitals  Manufacturers need to go through the bidding process province by province  Each bidding process takes approx. 3 months  Once a product wins bidding at a province, it will then need to obtain listing by hospitals  Hospital Listing is the contract that a hospital has agreed to carry the product Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 11
  12. 12. A 5-step price-setting process for RDL drugs by NDRC has been in place since March 2007 Step 1 Step 2 Step 3  Regulators visit the  A public  A new expert manufacturer hearing to  Evaluate the group on drug solicit public cost of the pricing will comments on product's raw assess the the proposed materials proposed price price  Propose a price Step 4  Group discussions Step 5  Completion of the group examinations  The revised system is intended to secure the integrity of the pricing process, with regulators selected at random and rotated on a five-year basis to minimize conflicts of interest  NDRC might be given expanded responsibility in the future to control prices of all prescription drugs and not just those on the NRDL Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 12
  13. 13. The development of the Reimbursed Drug List (RDL) is “top-down”, without drug-makers’ participation National RDL • National and provincial expert Central government entities committees and advisory boards – MoHRSS* • Clinical KOL’s – NDRC** • Pharmacy KOL’s – Ministry of Finance • Health economics KOL’s • Pharmacology KOL’s Provincial RDL • Experts are randomly selected • Provincial government entities to participate in reviews from – Pricing Bureau established Expert Databases – Provincial Bureau of HRSS • As soon as selected, experts – Provincial Finance Bureau are grouped together and stay "quarantined” Advocacy development with KOLs is crucial in moving products to RDL Copyright © 2012 Pacific Bridge Medical • www.pacificbridgemedical.com 13
  14. 14. Pricing and reimbursement dynamics - summary  RDL is “Product” specific, not “Brand” specific  RDL List B: mainly innovative drugs; partially reimbursed  The reimbursement ratio (reimbursed/co-pay) can be as low as 10% for some very expensive drugs  Certain premium drugs (such as oncologicals) may be better off as cash-pay compared to be on the RDL  A new segment - RDL List C has been in discussion for a couple of years  Retail prices of RDL drugs are determined by NDRC and local PB  Retail prices of non-RDL drugs are set by drug companies but approved by provincial divisions  The success of cash-pay drugs requires support of other commercial tactics  The National RDL is updated every 4-5 years  Regional differences of RDL and reimbursement ratio can be significant  Strong push for “zero” mark-up  Price/volume trade-off Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 14
  15. 15. Pacific Bridge Medical Connect with us today. address: 7315 Wisconsin Avenue, Suite 609E Bethesda, MD 20814 website: www.pacificbridgemedical.com Contact us through our website for a free 15 minute consultation. Sign up for our free monthly medical Asian eNewsletter. Copyright © 2012 Pacific Bridge Medical www.pacificbridgemedical.com 15

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