On May 15, the medical network released a list of children's drugs on the list, adding 40 to 72 varieties 

 

▍ add 40 varieties, let go! 

 

12, the national health development planning commission issued "on the second batch of encouraging r&d publication of the declaration for the children's medicine suggested list", including erythromycin, metformin hydrochloride and omeprazole 40 varieties to encourage application list. 

 

On June 1, 2016, the national health development planning commission website reported on the printing of the first to encourage research and development to declare the children's medicine listing notice, the first 32 varieties, digoxin injection and warfarin oral suspension liquid in the column. 

 

Children's shortage of medicine is a years old problems, children appropriate dosage form drugs specification lack, enterprise development and production of power and other issues have not been able to fundamentally solved. 

 

According to the national association of industry and commerce association, China has more than 6,000 pharmaceutical companies, with just over 10 pharmaceutical companies specializing in the production of children's medicines. There are more than 30 pharmaceutical companies that cover children's medicines. China specializes in producing less than 5 percent of medicines for children, and 90 percent of medicines have no children's edition. 

 

Drugs in the first batch of "listing", for example, covers the treatment of nervous, cardiovascular, endocrine, multiple system of common diseases such as blood, mostly already listed abroad, but domestic children lack of appropriate types and specifications. 

 

For example, the drug used for pediatric epilepsy, clonazepam, currently has only a tablet for oral preparation, and the presence of an oral solution will improve the compliance of children's patients. Common emergency drug epinephrine, domestic injection minimum specification is 0.5 mg, with minimal children dosage of 0.01 mg/kg body weight, encourage research and development to declare 0.1 mg/ml (1 ml) specifications will be greatly convenient for pediatric clinical medication, increase the dosage accuracy, reduce waste, reduce the medical risk; Some drugs belong to clinical chronic lack of drugs, such as therapy in the treatment of congenital hyperinsulinemia diazoxide and corticotrophin, etc for the treatment of infantile spasms. 

 

The first 32 varieties were concentrated in the area of neuro-psychiatric and cardiovascular medicine, which accounted for 50% of the total, according to cic. Of 32 kinds of drug dosage forms on injection, oral solution, oral suspension liquid three children appropriate dosage forms such as 78.12% of the total, therefore, in the process of children's medicine research and development for oral drugs can consider the development of oral liquid preparation. 

 

▍ children medicine tuyere 

 

On May 18, 2016, the state development planning commission and other six ministries issued "on the strengthening of the reform and development of children's medical and health services opinion", aimed at promoting the development of children's medical and health service system. There are currently about 220 million children in the country, and the market for children's medicines is huge. However, the problems of children's clinical trial have been slow, and the country has been guiding the development of children's drugs. 

 

For the development of drugs for children, cic advises companies to grasp the following points: 

 

One is clinical development of mature, high safety and efficacy of adult medicine, compared with the foreign children's drugs dosage form, through the improvement of types and specifications, development more types and specifications for use in children. 

 

2 it is in view of the domestic medical institutions for pediatric use homemade preparation, the preparation treatment effect is good, generally but less preparation production, cost is high, the enterprise can consider for further research and development production. 

 

The third is to target the foreign countries that have already listed and the quality original medicine that does not have at home, the special effect drug to carry on imitation. 

 

Not only will the registration process be released, but the patent protection of new drugs will also be the first to be tilted in these 72 varieties. 

 

On May 12, the drug safety administration announced "about to encourage pharmaceutical medical equipment innovation policies of protection of innovators (draft)", specifically to belongs to belong to the rare diseases and innovative drug administration decongestion, children, give 10 years data protection; It is a rare medical treatment for a modified drug, a special treatment for children, and a three-year data protection period, which focuses on the window of the child's medication. 

 

The attached: 

 

The second batch encourages the development of the list of recommended children's medicines