Registering a Medicine in China.

Regulatory Affairs

Pharmaceutical industry in China (Wikipedia, not totally trustable)

The industry environment has been transformed for the better over the last 10 years. Entry to the WTO has brought
a stronger patent system, medical insurance is now more widespread, and pharmaceutical-related regulations have
been stiffened. China is reportedly expected to become the third largest pharmaceuticals market in the world by 2011.

The most influential issues for foreign companies are the decree of Administration Method of Import
Pharmaceuticals recently promulgated by the State Drug Administration, and the launch of a new version of
registration certificate for import pharmaceuticals.

Regulatory agencies: State Food and Drug Administration (SFDA): As part of the government restructuring
announced in March 1998, the Ministry of Health's Department of Drug Administration merged with the State
Pharmaceutical Administration of China (SPAC) to become the State Drug Administration (SDA). As a result, SDA
oversees all drug manufacturing, trade, and registration. In 2003, the SDA was restructured to become the State Food
and Drug Administration.

The Ministry of Health retains its other main functions-regulatory development and oversight, healthcare resource
allocation, and medical research and education. The Chinese government's establishment of a single drug regulatory
authority was an important step toward foreign access, because it eliminated the conflicting standards that prevailed
among provincial government agencies, centralized the Chinese healthcare regulatory system, and made it more
transparent.

SFDA now oversees all medications-both Western and TCM-as well as advertising. Its new regulations follow FDA's
model. Depending on the product and circumstance companies seeking to receive pharmaceutical approval might
additionally have to register their product with the General Administration of Quality Supervision, Inspection and
Quarantine AQSIQ. In July 1999, as part of medical insurance reform, SFDA released its first list of over-the-counter
(OTC) medications, and in 2000, the state began to regulate OTC and prescription drugs separately.

The SFDA plans to cut the number of manufacturers down to around 2,000 over the next two years by attrition and
by requiring remaining firms to meet the new GMP standards. In fact, SFDA required all pharmaceutical companies in
China to obtain GMP certificates from SFDA by June 30, 2004 to be licensed to sell their drug products in China.

Ministry of Commerce: The government organization regulates the import and export of medical devices and
equipment, collects and analyzes import and export data, and carries out anti-dumping investigations.

State Population and Family Planning Commission: The agency writes the regulations on the use of birth control
tools and pills.

State Quality Control Administration: It enacts and implements national standards.

Industrial Associations: Include China OTC Association, China Pharmaceutical Quality Management Association,
China Pharmaceutical Commerce Association, and others.

China quickly advanced its pharmaceutical-related regulations around the time of its December 2001 entry into the
World Trade Organization (WTO). China has strengthened patent protection: In conformity with the WTO/TRIPS
agreement, the patent protection structure adopted by China approaches that of Japan, Europe, and the US.
 China has also implemented new drug administration laws designed to streamline product registration and protect
Intellectual Property Rights (IPR). China has agreed to six years of "data exclusivity" and has committed itself to
implementing a patent linkage system.

Government drug pricing policy: retail prices of pharmaceutical products qualified for the program and included in
the National Basic Medical Insurance Scheme Drug Catalogue will be regulated. The pricing mechanism is based upon
three considerations when setting the maximum retail price - production cost, a wholesaler spread set by the
government and the prices of comparable products in the market. Any products priced above this level will be cut.

GMP compliance certification: Currently nine government agencies are the key agencies responsible for regulation.
They are the State Food and Pharmaceutical Administration (SFDA), the State Development and Reform Committee, the
Commerce Ministry, the State Traditional Chinese Medicine Administration, the Ministry of Labor and Social Security,
the Ministry of Health, the State Population and Family Planning Committee, the Ministry of Science and Technology,
and the State Quality and Technology Supervision Administration. In addition, more than 10 industrial associations also
regulate the industry.

Comparison of regulatory requirements with other countries: There should be no big differences between rules of
China and those of the U.S. Pharmaceutical, partly because China is following and copying U.S. rules. There is only
federal regulation on new drug application, but there are both local regulation and national regulation regarding pharma
expenditures of hospitals, reimbursable drug lists, and other issues. National regulation is implemented by SFDA and
other state agencies, while local regulation is implemented by provincial agencies. There is a mechanism for approving
new drugs (from NDA filing to approval). A full three-phase research trial takes three to five years, similar to the U.S.,
while requirements to start a trial are onerous by foreign standards, according to Western drug-company executives.
Although the approval time is being shortened, there still remain many aspects where transparency is lacking.

Distribution: Drugs are distributed in China through the Chinese-style channels. China has a three tiered distribution
system. At the top of the ladder are national level-1 stations in Beijing, Shanghai, Shenyang, Guangzhou, and Tianjin.
These allocate products to provincial level-2 distributors, who in turn sell to county and city level-3 wholesaler-drug
stores. At the bottom of the distribution chain are China's vast numbers of small retail stores are difficult to reach
individually.

Chinese Pharmaceutical Association (wiki)

It’s the regulatory and professional body for pharmacists and pharmaceutical scientists in China. It is headquartered
in Beijing. It is a member of Chinese Association for Science and Technology (CAST), International Pharmaceutical
Federation (FIP), and Asian Federation for Medicinal Chemistry (AFMC).

State Food and Drug Administration (wiki)

The State Food and Drug Administration is directly under the State Council of the People's Republic of China, which
is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the
competent authority of drug regulation in mainland China.

Main tasks:
 To be in charge of drug registration, draw up, revise and promulgate national standard of drugs; draw up
criteria for marketing authorization of health food; review and approve health food; set up classification
system for prescription drugs and OTC drugs; establish and improve ADR monitoring system; be responsible
for drug reevaluation, review drugs to be withdrawn and formulate a national essential medicines list.
  To direct national drug regulation and comprehensive supervision on the safety management of food, health
food and cosmetics.
 To carry out exchanges and cooperation in drug regulation, relevant safety management of food, health
food and cosmetics with foreign governments and international organizations.

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)

(wiki)
It’s in charge of national quality, metrology, entry-exit commodity inspection, entry-exit health quarantine, entry-
exit animal and plant quarantine, import-export food safety, certification and accreditation, standardization, as well as
administrative law enforcement.

AQSIQ directly administers provincial Entry-Exit Inspection and Quarantine Bureaus and Bureaus of Quality and
Technical Supervision.

Similarities and Differences in Device Submissions for the USA, EU and China
PowerPoint presentation. Not downloaded yet.

The Regulation Of Medical Device In China

Got this .ppt

The Regulatory regime for Medical Devices in the People’s Republic of China
Comments from ABHI (Association of British Healthcare Industries)

China (by Pacific Bridge Medical)

China Pharmaceutical Regulation Strategies (Pacific Bridge Medical)

The first issue is to establish a China pharmaceutical registration- either as a chemical drug, biological drug, or
Traditional Chinese Medicine (TCM). Drugs can be imported into China only after they obtain product approval from the
State Food and Drug Administration (SFDA)- the China drug administration.

The Chinese government pays for almost all of the drugs on the National Medical Insurance Drug List. There are
also specific China drug regulations on advertising, labeling, and packaging. Clinical research and clinical studies are also
exploding in China.

China SFDA (Pacific Bridge Medical)

The State Food and Drug Administration (SFDA) is akin to the FDA of the United States. This regulatory entity
regulates drugs, medical devices, health foods and cosmetics. There are ten departments under the SFDA. The three
departments that are of relevance to medical devices and drugs are the Department of Medical Devices, the
Department of Drug Regulation and the Department of Drug Safety and Inspection. There is a decentralization of
authority within the SFDA that allows provincial SFDAs to operate relatively independently of the national SFDA.

Depending on the product being exported to China, a company may need to additionally register with the General
Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ).

Medical Device Regulatory Requirements for China

Regulatory Agencies

There are three Chinese agencies that have regulatory roles for imported medical equipment. Depending on the
product being exported to China, a company will need to register with the State Food and Drug Administration (SFDA),
and may be required to receive approval from the Ministry of Health (MOH), or the General Administration of Quality
Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ). In addition, for medical device
products which fall into the category of pressure vessels, Chinese Customs requires certificates issued by the Safety
Quality Licensing Office for Import Boiler and Pressure Vessels (SQLO) of the State Administration for Technical and
Quality Supervision, in addition to SFDA and AQSIQ certification.

State Food and Drug Administration (SFDA):

Regulation of medical devices falls under the jurisdiction of the State Food and Drug Administration. This
government ministry is roughly equivalent to the U.S. Food and Drug Administration, and was previously known as the
State Drug Administration. All imported medical devices must get a registration certificate from SFDA before being sold
in China. The SFDA has a comprehensive system for medical device registration and inspection, which includes product
type testing and factory audits.

Ministry of Health (MOH):

The Ministry of Health (MOH) is in charge of drafting laws, regulations, and policies related to public health,
overseeing the administration of Traditional Chinese Medicine, and for administering China’s rural health insurance
system. MOH responsibility for the procurement of medical equipment on the provincial level includes overseeing the
bidding and tendering process for medical devices and pharmaceuticals sold to State run hospitals.

Chinese hospitals are divided into for-profit and nonprofit units and allowing patients to choose hospitals. Nonprofit
units may enjoy preferential tax policies while for-profit services may set their own prices but must pay taxes. For-profit
hospitals, which include Sino-foreign joint ventures and clinics, must apply to the MOH for approval and may only treat
self-funded patients. In addition, joint ventures must use advanced equipment and technology and offer services that
local hospitals cannot.

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ):

The General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China
(AQSIQ) is tasked with overseeing inspection, quarantine, and establishing the technical standards of goods for import
and export. AQSIQ maintains responsibility for certifying electrical safety for a wide variety of products, including some
electro-medical devices. Upon certification, products receive a "China Compulsory Certification” (CCC), mark which
serves as evidence that the catalogue-covered products can be imported, marketed and used in China.
 Laws and Regulations

The Regulations for the Supervision and Administration of Medical Devices, enacted in April 1, 2000, is the
fundamental law governing China’s health sector. The law has been amended several times, and recent changes to
various sections can be found on the SFDA website.

China medical device regulatory issues: (by EMERGO)

* Determine device classification.

* Ascertain the best route to SFDA approval in China.

* Development of a Product Registration Standard.

* Develop clinical protocols and coordinate clinical trials, if required.

* Translate documents and labeling.

* Obtain the CCC Mark, if required.

* Prepare final submissions and act as official Legal Agent and After Sales Agent in China.

* Handle incident reporting, SFDA inspections and device registration renewals.

The Chinese CCC Mark certification stands for China Compulsory Certification. The CCC Marking
applies to a broad range of automotive, toy, home decor, wireless, machinery, safety and other
products, but only to a select group of medical devices, most of which have an electrical
component. All devices that need Chinese CCC certification must be tested by a lab in China.

Life Sciences and Medical Device Translation Specialists

Determining whether a product is a drug or device becomes especially critical in the case of combination devices, or
with products that could be regulated as a pharmaceuticals based on the claims and intended use defined by the
manufacturer. Improper classification, slight changes to formulations, or excessive claims of performance can have a
staggering impact on the regulatory approval process and its associated costs.

http://www.emergogroup.com/services/regulatory-overview#china

New industry standards for medical devices in China (+MASS DEVICE.com)

On Dec. 27, 2010, China’s State Food & Drug Administration (SFDA) website was updated with an announcement
on 96 new industry standards that will affect medical devices in China. 34 of these new industry standards are
mandatory (labeled YY) while the remaining 62 are recommended (labeled YY/T). The mandatory standards will be
regulated beginning June 1, 2012. Several of the mandatory industry standards are replacing other standards.
State Food and Drug Administration (chinese webpage, I love google chrome!)
About promulgated YY 0054-2010 "hemodialysis equipment" and other medical equipment industry standard 96
announcement. A huge list. Nothing is directly related apparently.

SFDA webpage (Chinglish version)

Regulatory Guide Laws & Regulation

China Ministry Of Health

The English version of www.moh.gov.cn is under construction.

General Administration of Quality Supervision, Inspection and Quarantine -

Certification and Accreditation Administration
I have to expend more time with this chinese webpages…

National Standardization Technical Committees

Centre for medical Device Evaluation