The U.S.-Japan Regulatory Reform and Competition Policy Initiative issued its sixth report this June. The report outlined various recommendations to facilitate economic growth and increased trade between the two countries, including plans for the medical device and pharmaceutical market. Most of the... Read More
Taiwan’s Department of Health (DOH) plans to introduce a Health Technology Assessment (HTA) system to control rising healthcare costs. This HTA system would require all medical devices, new drugs and innovative surgical procedures to demonstrate effectiveness in improving patients’ health and cutting... Read More
In January 2007, the revised International Code of Pharmaceutical Marketing Practices developed by the International Federation of Pharmaceutical Manufacturers & Association (IFPMA) became effective. Though the Singapore Association of Pharmaceutical Industries (SAPI) is part of the IFPMA, it has only recently stated... Read More
In February 2007, the Philippine Senate passed the bill SB2263. This bill shortens the period of patent protection, legalizes parallel importation, allows local generic companies to experiment with drug formulations before patents expire and allows various other actions to help lower drug... Read More
India’s National Pharmaceuticals Pricing Authority (NPPA) has recently introduced an online e-filing system for applicants wishing to apply for pricing or revised pricing of their medical product. The price list is listed under Forms III, IV, and V of the Drug Price... Read More
The Philippines’ Department of Health (DOH) has recently issued Administrative Order No. 2007-003 which transfers some medical device regulation responsibilities from the Bureau of Food and Drugs (BFAD) to the Bureau of Health Devices and Technology (BHDT). Joint Bureau Memorandum No. 2007-1... Read More
The biotech market in Japan is one of the largest in the world at over $15 billion. With various government incentives such as tax exemptions and annual funding, the biotech market is steadily growing. Foreign companies have also increased their presence with... Read More
Despite numerous rounds, the US and Malaysia continue to have ongoing negotiations over the regulations of drugs and patents under a future Free Trade Agreement. The deadline for fast-track approval has passed, and resolutions to patents and generics regulations are not forthcoming.... Read More
The Ministry of Health, Labor, and Welfare (MHLW) has recently focused on the generics market, with new regulations and planned regulations for the future. On April 18, 2007, the Central Social Insurance Medical Council (Chuikyo) approved adding generic drugs to the National... Read More
When registering a medical device in Korea, an applicant must demonstrate Korean GMP (KGMP) compliance. Previously, under the Pharmaceutical Affairs Act, foreign manufacturers could demonstrate KGMP compliance with an ISO 1348:2003 or US FDA QSR certification. Also, KFDA audits only applied to... Read More