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"1 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
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
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"2 and "High Demand
The main changes set out in the Proposals to Expedite
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.
1 "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
published by Ministry of Health. These Essential Pharmaceuticals
are also subject to price regulation by the State Development and
2 "Innovative Pharmaceuticals" are those
pharmaceuticals that target critical diseases and result in the
creation of Chinese intellectual property.
3 "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 content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
What happens if a patient, particularly a mental health patient,.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).