INCREASED TRANSPARENCY AND EFFICIENCY IN CHINA'S MEDICAL DEVICE REGULATORY SYSTEM
With growing concerns of quality control in China, the U.S. will soon have access to records of Chinese manufacturers failing to comply with regulations. China’s State Food and Drug Administration (SFDA) and the US Department of Health and Human Services (HHS) issued a memorandum of understanding (MOU) with various initiatives to improve China’s medical device industry.

For foreign companies interested in sourcing their medical products and setting up partnerships, this MOU will hopefully help raise the quality of local Chinese medical device manufacturers. Under the MOU, China will certify the safety of specified exported medical devices and create product-tracking systems. The SFDA will also notify the US FDA if a facility does not meet inspection requirements or has its certification revoked. In addition, the SFDA plans to create a system certifying Chinese firms and products that meet US FDA standards.

Other China medical device related plans were developed in the 18th US-China Joint Commission on Commerce and Trade. For medical devices, China agreed to eliminate redundancies in testing and certification requirements for imported medical devices. China plans to implement a “one test, one fee” policy to establish a single conformity assessment system for medical device testing.

China has also agreed to suspend implementation of AQSIQ (General Administration of Quality Supervision, Inspection, and Quarantine) Decree 95, which would have increased testing and inspection redundancies focused specifically on imported medical devices.

DRUG PRICE REVISIONS AND CUTS IN THAILAND
This month, Thailand’s Ministry of Public Health announced a new national drug list with lower prices for drugs treating cancer, glaucoma, and anemia.

In accordance with this revised drug list, the Ministry has pushed for pharmaceutical firms to reduce cancer drug pricing by over 60 percent over the last few months. The Ministry met with multi-national companies such as Sanofi-Aventis and Novartis to negotiate pricing and stated that drugs could not be added to the national list without lower prices.

Thailand’s Food and Drug Administration (FDA) said the new drug list will be announced in the government gazette. It will then be distributed to all hospitals in the country. Thailand’s FDA started revising the 692 products listed in the old national drug list last year to account for the cheaper and newly developed drugs currently on the global pharmaceutical market. The old national drug list is from 2003, and many global prices have dropped since then. In addition, the FDA is adding new effective drugs recently released on the market.

Thailand’s FDA removed 33 drugs from the old list and added 24 new drugs. The new drugs added include Novartis’ imatinib for leukemia and gastric cancer, Sanofi-Aventis’ docetaxel for lung and breast cancer, Allergan’s bimatoprost for glaucoma, and others.

RISE OF IMPORTED MEDICAL DEVICES IN INDIA LEADS TO PRICE CONTROL TALKS
India’s growing medical device market has prompted many multinational companies to open their own local offices in the country. In 2007 alone, over 25 foreign medical device companies such as Boston Scientific, Medtronic, Abbott, DePuy and others received product import clearances for their local subsidiaries in India. Market growth can also be seen in the increase of medical device patents. The Society for Economic and Social Studies in India found that 64 patents had been granted for medical devices in India in the past two years.

With more foreign medical devices entering the country, the Indian government has decided to expand one of its government committees to discuss pricing on medical devices. This government committee was originally focused on price negotiations for patented drugs and developing a system of reducing prices of imported medicines. Now, the same committee will also explore the possibility of price negotiations for medical devices before granting marketing approval. The committee consists of members from various government and health ministries, such as the CDSCO (Central Drugs Standard Control Organization) and the NPPA (National Pharmaceutical Pricing Authority).

The committee is now authorized to interact with various medical device and pharmaceutical industry associations to determine an appropriate pricing system such as reference pricing or differential pricing. Then, the committee will conduct price negotiations on the imported drug or medical device. Imported medical devices or drugs without negotiated pricing would not be licensed and sold in India.

India’s medical device market is worth $2.5 billion today and its future expected growth rate up to 2010 is projected at 15%.

GROWING FOREIGN INVESTMENT IN VIETNAM'S PHARMACEUTICAL INDUSTRY
After joining the WTO in January 2007, Vietnam has seen a sharp increase in foreign investment in its pharmaceutical industry. In 2007 alone, there were 58 new foreign businesses in this industry. Vietnam’s Ministry of Health reported that by the end of October 2007, there were a total of 370 licensed foreign companies involved in the production of drug products and APIs.

Locally-made drugs meet about 50 percent of demand, leaving the other 50 percent to imported products. In addition, public spending on drugs increased from $8 in 2004 to $13 in 2007. In 2007, Vietnam imported over $700 million worth of drugs and raw materials. Most imported medicines are more general products, such as anti-bacterial agents. Many Vietnamese companies are also dependent on imported raw materials. In fact, over $160 million was spent in 2007 on importing raw materials, an increase of 23 percent from 2006.

Vietnam has 180 pharmaceutical factories, 75 of which meet Good Manufacturing Practices (GMP) standards. 25 of those 75 factories are foreign-invested.