Another 2.2 billion yuan of prescription drugs need to be transferred to OTC (with variety table attached)

Source: Xinkangjie on January 6, 2016, at the end of 2015, CFDA announced that 16 kinds of drugs, such as bailing capsule, were transformed from prescription drugs to over-the-counter drugs According to the announcement, the relevant enterprises should be on January 30, 2016 Recently, according to the measures for the administration of drug registration and other relevant provisions, a supplementary application for the revision of the manual was submitted to the food and Drug Administration for the record, and the revised contents of the manual were timely notified to the relevant medical institutions, drug trading enterprises and other units In addition, other contents of the manual other than those specified in the model manual of OTC drugs shall be executed according to the original approval certificate If the drug label involves relevant contents, it shall be revised at the same time For drugs produced since the date of supplementary application for filing, the original drug instructions shall not be used any more Double span prescription drug instructions can be used continuously It is understood that the conversion of a drug from a prescription drug to an over-the-counter drug requires long-term clinical data accumulation to prove that the drug will not be over used, improperly used, or safety problems due to human differences in OTC sales mode CFDA will approve a certain number of prescription drugs to be OTC every year In 2015, in addition to the above-mentioned 16 prescription drugs to be over-the-counter drugs, 13 drugs such as andrographolide were approved to be over-the-counter drugs in May 2015, 35 over-the-counter drugs were also approved to be over-the-counter drugs in 2014 and 20 in 2013 In terms of the number of over-the-counter drugs converted every year, it is basically kept between 20 and 40 varieties The applicant needs to apply for the conversion of the varieties it produces or acts as its agent when the prescription drugs are converted to over-the-counter drugs Generally speaking, prescription drugs are adjusted to over-the-counter drugs, mainly because these drugs are identified as low potential risks after use and monitoring In the world, it is still very prudent to convert prescription drugs to over-the-counter drugs For example, it is still difficult to convert prescription drugs to over-the-counter drugs in the United States Pfizer tried to convert Lipitor into over-the-counter drugs in the United States, but finally gave up after relevant clinical trials At present, the number of prescription drugs converted to over-the-counter drugs in China is mainly due to the variety of Chinese patent medicines Take the 16 varieties converted to over-the-counter drugs as an example, only minoxidil liniment belongs to chemical drugs, and the others are all Chinese patent medicines CFDA's latest published sales of 16 over-the-counter drugs in 2014 (100 million yuan) data source: Zhongkang CMH