NCE-2 regulations loosen restrictions on old drugs and seek new opportunities in Taiwan. Food and Drug Administration: Encourage domestic development | Medical Voice News | Medical Voice

Old medicine comes to Taiwan to find a chance to survive! In order to encourage the country to accelerate the development of new ingredient drugs and allow the public to have more drugs available, as long as they have been on the market for five years in the top ten advanced countries and are classified as new ingredients and new drugs (NCE-2) in Taiwan, the registration information can be simplified. Director-General Wu Xiumei pointed out that in addition to submitting technical information or evaluation reports from the approving country, this type of new drugs can also be subject to small-scale clinical trials in China. After obtaining the drug certificate, the administrative protection period will be 5 years to encourage the development and manufacturing of domestic pharmaceutical companies. .

As early as 2013, the government announced that “the ten-year limit for approval of marketing in the top ten advanced pharmaceutical countries, but it is the key points for inspection and registration review of domestic new patent medicines and new drugs” (NCE-2), which can simplify the inspection and registration application materials of drugs. Recently, in order to encourage domestic industry players, last year’s announcement was made to amend the 10-year listing limit to five years.

Wu Xiumei pointed out that drug patents are a territorial policy. Because new drugs were delayed in coming to Taiwan, the NCE-2 regulations were introduced to encourage foreign manufacturers to come to Taiwan, or domestic manufacturers to buy APIs and manufacture them in Taiwan. Therefore, during the inspection and registration review, other Technical qualifications must be submitted to literature or evaluation reports or test reports from the approving country. If a pharmaceutical company is willing to conduct small-scale clinical trials in Taiwan, the pharmaceutical company can obtain a five-year administrative protection period after obtaining the drug certificate, and other pharmaceutical companies are not allowed to produce counterfeit products.

Due to the serious shortage of antibiotics, the government also hopes to use NCE-2 to encourage domestic pharmaceutical companies to develop new ingredients and new drugs. Currently, there are 596 licenses for antibiotic preparations in Taiwan, and the total number of first-line antibiotics commonly used in health insurance is about 245. Most of them are generic drugs from domestic pharmaceutical companies, and only about four licenses have been imported. There are 172 antibiotic API licenses, of which about 7 are domestically produced. China and India account for more than 50% of APIs.

Judging from the data, there are not many applications for antibiotics even from foreign pharmaceutical companies. In recent years, there have been 12 new drug licenses in the world, but only 3 drug licenses have been applied for in Taiwan. Wu Xiumei pointed out that in terms of optimizing the review and registration of new drugs, if it has been Listings in Europe, the United States and Japan can all go through streamlined review, which takes about 120 days. If they are listed in the two countries, it takes about 180 days, which is much shorter than the 360 ​​days of general review.

Nowadays, in response to the unknown epidemic and international situation, the Food and Drug Administration has added 48 new antibiotic products. Wu Xiumei pointed out that we encourage domestic pharmaceutical companies to manufacture and develop new drugs in Taiwan. With the experience of the new crown epidemic, we will now also hope that domestic raw materials Medicines can also be delivered as quickly as possible, reinforcing the importance of independence and self-sufficiency.

In addition, in order to encourage the use of generic drugs in the country, the National Health Insurance Department has launched a three-in-one policy, which means that as long as it is the same ingredient, same dosage form, and same dosage specified by the Food and Drug Administration, the same benefit will be paid. However, the Taiwan Infectious Diseases Society Honorary Chairman Zhuang Yinqing said that front-line clinicians actually know the differences in the efficacy of the same drug from each manufacturer, so they should collect relevant information and make adjustments to government agencies. Wang Fude, chairman of the Taiwan Infectious Diseases Society, pointed out that some domestically produced generic drugs are not very effective and have an impact on the treatment effect.

Wu Xiumei suggested that the medical association should notify the Food and Drug Administration for review if there are drugs that are not as good as expected. In addition, if there is a clinical demand for new antibiotic drugs and the drugs have not come to Taiwan, they can submit a drug list to the Food and Drug Administration, and the Food and Drug Administration will follow up with the drug. Communicate with the factory and help them introduce it to Taiwan.

(Editor: Zhou Peiyi)