Jurisdiction - China
Reports and Analysis
China – State Food and Drug Administration Bulletins.

13 March, 2013

 

I. Consolidation of Pharmaceutical Sector

 

On 22 January 2013, the PRC’s National Development and Reform Commission issued guidance on accelerating consolidation within the pharmaceutical sector (“Consolidation Guidance”). The Consolidation Guidance sets out these goals to be achieved by 2015:

 

  • Combined sales revenues from the top 100 PRC pharmaceutical companies should account for more than 50% of total PRC pharmaceutical sector sales revenue; and
  • the top 20 PRC pharmaceutical companies selling “Essential Pharmaceuticals” (“Essential Pharmaceuticals” constitute a subset of the total PRC pharmaceutical market called “基本药物”, which are mostly generic pharmaceuticals that are listed in the Catalogue of Essential Drugs (国家基本药物目) published by Ministry of Health. These Essential Pharmaceuticals are also subject to price regulation by the State Development and Reform Commission) should account for 80% of all Essential Pharmaceutical sales in China.

 

II. Whistleblower Measures for the Pharmaceutical Sector

 

On 8 January 2013, the State Food and Drug Administration (“SFDA”) published Measures for Rewarding the Reporting of Illegal Activities Involving Food and Pharmaceuticals (“Whistleblower Measures”) The Whistleblower Measures provide monetary rewards to the public (up to RMB 300,000) for the reporting of information concerning illegal development, production and/or circulation of pharmaceuticals, medical devices, health foods or cosmetics. The Whistleblower Measures complement the SFDA “Blacklist” that became effective 1 October 2012, which is an online SFDA resource available to the public that “names and shames” regulatory infringers

 

.III. Proposals to Expedite Review and Approval of Pharmaceuticals

 

On 31 December 2012, the SFDA released draft proposals (“Proposals to Expedite”) for public comment until 15 January 2013 concerning changes to expedite the pharmaceutical review and approval process for “Innovative Pharmaceuticals” (“Innovative Pharmaceuticals” are those pharmaceuticals that target critical diseases and result in the creation of Chinese intellectual property) and “High Demand Generics” (”High Demand Generics” are generic pharmaceuticals that treat rare or special diseases, have a paediatric application or have clinical demand that exceeds the pharmaceutical’s current supply in the market).

 

The main changes set out in the Proposals to Expedite include:


  • reducing approval time for Innovative Pharmaceuticals by adjusting standards and technical review requirements
  • optimising procedures and improving pharmaceutical review efficiency, including allowing applicants to provide supplementary materials as their research progresses;
  • reviewing applications for High Demand Generics on a high-priority basis, thereby reducing approval time;
  • clarifying key technical review points for applications related to High Demand Generics 
  • streamlining clinical trial quality controls; and
  • encouraging development of paediatric pharmaceuticals.

 

 
For further information, please contact:
 
Michael Cripps, Regional Head of Corporate Insurance, Clyde & Co
michael.cripps@clydeco.com.cn

 

Homegrown Regulatory & Compliance Law Firms in China

 

 

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