In recent years, the shortage of medicines for children has been a major concern for the society. In order to solve this problem, the relevant encouragement policies have been published frequently since 2015, and the professional development of children's medicine has become an inevitable trend. The national center for drug approval (CDE) for the market shortage of children's medicine give priority review qualification examination and approval, so far, more than 24 children's drugs have been incorporated into the priority review directory. 

 

One of the world's first treatments for full-body juvenile arthritis (sJIA) has been approved in October 2016. The world's only magnus capsule, which is used in the treatment of a rare form of the disease, was approved in November 2016. 

 

background 

 

Customization is imperative 

 

According to China's sixth census, the population aged between 0 and 14 accounts for 16.6% of the total population, at 230 million. It is predicted that after the implementation of the comprehensive "two-child" policy in China, the number of babies born in China will be around 20 million per year, with an increase of about 3.4 million people in 2016 from 2015. And the newborn babies will be the subject of demand for the next 10-15 years. 

 

In September 2016, the first report on the safety of children's drug safety in 2016 was released by the first child safety drug dissemination and development conference. "White paper", according to Chinese children's adverse drug reaction rate is twice the adult, newborn was 4 times, and our children, drug is less than 2%, a pediatrician gap in 200000. 

 

Data show that at present our country children number of cases accounted for 19.3% of the total, in the existing more than 3500 kinds of drugs, only more than 60 meant for use by children, accounts for about 1.7% of all varieties of pharmaceutical preparations. More than 95 percent of the medicines are not packaged in children's safe packaging, and are not equipped with special units. In China, more than 6, 000 pharmaceutical companies are specialized in the production of medicines for children, and there are only over 30 enterprises with children's drug production departments. 

 

In addition to the shortage of species, children have fewer dosage forms and specifications. Children commonly prescribed in the most used three kinds of formulations for injection, tablet and oral solution, suitable for children of dosage forms, such as powder inhaler, suppositories, syrups, drops, aerosol, breed is very limited. Owing to shortage of appropriate children varieties, specifications, dosage forms, most medicine for children caused by adult drug dosage or have to super manual use, the drug safety for children has brought a big hidden trouble. 

 

The policy dividend continues to be released 

 

In February 2015, issued by the general office of the state council "about perfecting public hospital drug centralized procurement guidelines", clearly put forward fu hang net purchase drugs directly, there are many provinces to follow up. Also has the expert points out, may refer to the WHO model list of essential medicines for children, to establish China's "children's basic medicine catalogue", for different drug dosage form specification is applicable to different age groups to make a clear division. 

 

In May 2016, countries who do department released the list of the first encourage r&d to declare the children's medicine, medicine for children to do a better job of security work, promote children adapted varieties, dosage form, specification development initiatives and declare review, encourage the development of domestic children lack of drug dosage forms and specifications. In may this year, the second batch of encouraging research and development of children's medicines was released. 

 

Released in November 2016, the national center for drug approval "adult medicine data extrapolation in the pediatric population of drug clinical trials and the relevant information of the technical guidelines" (draft), the purpose is to encourage the development of pediatric drugs, in children's drugs are difficult to acquire the difficulty of clinical data. 

 

In January 2017, the general office of the state council issued "on further reform and improve the use policy for producing and distributing medicines of several opinions" (hereinafter referred to as "opinions"). In terms of optimization of drug approval for examination and approval procedures, "opinions" clearly pointed out that the urgent clinical needs of shortage of new drugs and drug approval to speed up the review, the review of new drugs to highlight the clinical value and generic drug review in strict accordance with the quality and curative effect with the original drugs consistent principle. At the same time, we will learn from the advanced international experience, and explore the way of examination and approval of such categories as rare diseases, children, elderly people, urgent (snatch) rescue and medical treatment and traditional Chinese medicine. And the patent medicines required for the prevention of major diseases shall be enforced in accordance with the law if necessary. 

 

In February 2017, the ministry of human services announced a new list of national health care medicines, with the increase in the number of children being given the number of medicines showing the importance of the new directory for weak links. A new list of 91 children's medicines is being added to the new medicines list, which is clearly applicable to 540 medicines or dosage forms for children, and increased the use of medicines for children. 

 

market 

 

The growth is expected to be 14.4 percent by 2020 

 

According to sample hospital statistics, 2015 samples of domestic hospital children's drugs market scale is 20.53 billion yuan, medical insurance directory children's drugs market scale is 12.55 billion yuan, accounting for 61.14% of the national children's drugs market. The total number of children in the sample hospital for 2016 was 13.72 billion yuan, an increase of 9.3%, which is higher than the rate of growth of the overall children's drug market. According to experts, the market for children's medicines in China will exceed 130 billion yuan by 2020, an average annual increase of 14.4%. 

 

TOP 5 

 

In 2016, the top five products for domestic children's drug market were: The stomach-reducing tablets of the jiangi pharmaceutical industry accounted for 5.63 percent. In shandong province, the vitamin AD droplet/capsule of Marine bio-pharmaceutical is 4.37%. Ji chuan pharmaceutical has 2.28 percent of the heat in the black bean. The two live microbium particles in Korean and American drug companies make up 2.64% of the bacteria. 

 

 

 

In 2016, the top five drugs for children's drug use were: Kechuan pharmaceutical has 5.38 percent of the children's black bean. The munrustt chewing film of the drug was 5.20%; The static injection of immunoglobulin (PH4) in the taibang biology of shandong was 4.41%; The U.S. drug maker's polio calcium D3 particle is 3.23 percent. 

 

 

 

Three kinds of children prescription drugs are home-made 

 

Data show that children's prescription biggest three categories, respectively, anti-infection drugs, respiratory medicine and to the digestive and gastrointestinal drug use, on the whole is given priority to with domestic drugs. The prevalence of childhood respiratory diseases is at the top of the list, with fever, cough, bronchitis, asthma and pneumonia among the most common. The second most common type of disease is the children's digestive system, the most common type of disease, including indigestion, childhood diarrhea, and gastroenteritis. These are the main components of common childhood disease. 

 

varieties 

 

Include priority reviews 

 

Currently, CDE has released 18 approved catalogue for the first review, with 24 children being given priority reviews. 

 

Involved in 1 batch of 2015, the first batch of products, a total of 5, respectively is: chlorine ferrari marina injection, oral solution, hydrochloric acid left b raschig clindamycin palmitate particles, propranolol hydrochloride oral solution, children use sodium e.faecalis dry syrup. 

 

Involved 7 batches of 2016, among them: the first involves four children's products, respectively is chlorine ferrari marina and chlorine ferrari marina injection, caffeine citrate injection and propranolol hydrochloride oral solution, children use e.faecalis sodium; The fifth group involved three children's products, including dexamethimine nasal spray from dextrine hydrochloric acid, the oral solution of topoxetine hydrochloride, and McGonagall capsule. The ninth group involved two children's products, the glycemic insulin injection and the injection of the injection. Tenth batch products involving children 4, respectively was left b rasching temple and left b raschig sodium injection, injection from rice farmer peptide liposomes, salmeterol assigned powder inhaler. The tenth deals involving children's products, namely, the children's leprosy cough and asthma. The 12th group involved one of the children's products, the oral 5-valent redistributing rotavirus (Vero cell); Involving children product 3, 13 were human recombinant platelet hormone injection, degree of sugar peptide injection and lidocaine hydrochloride powder without needle percutaneous injection of drug delivery system; The 14th group involved two children's products, the children's faropeian sodium pellet, and the laba sea. 

 

Recently listed variety 

 

The main products of the recent batch of children's drugs have been approved in October 2016 by the new indication of the new indications for the new indications for the injection of the new drug. McGonagall's capsule was approved in November 2016. 

 

 

 

1, tozhuzumab (roche) 

 

Joe bead single fight is a fight interleukin - 6 receptor monoclonal antibody, is the world's first humanized monoclonal antibody against IL - 6 receptor, at the end of 2013 officially listed in China, mainly used for the treatment of rheumatoid arthritis. 

 

In 2010, it was approved by the U.S. FDA for the treatment of sJIA, the first active sJIA in the world to treat the drug. SJIA is a rare and potentially life-threatening disease that causes severe inflammation in children. The difference between sJIA and other types of juvenile idiopathic arthritis (JIA) is that its systemic inflammation is prominent. 

 

In July 2016, CDE published a review of roche's application for the treatment of sJIA for sJIA. In October 2016, the injections were approved for the injection, which is called the yameiro, and the dosage form is an injection, with three specifications, 80mg / 4ml, 200mg / 10ml, 400mg / 20ml. 

 

McGonagall capsule (love tarlong) 

 

McGonagall capsule is a glucose neuramide synthesis enzyme inhibitor. C NPC peak disease is a rare autosomal recessive lysosomal storage disorder, main onset period for late stage infant and young, the symptoms of nervous system as the main performance, including vertical resistance on nuclear gaze palsy, cerebellar ataxia, and difficulty pronouncing words. The development of these symptoms significantly affects the growth and development of the child, and the symptoms worsen rapidly. 

 

In 2006, the product by the European food safety as orphan drug treatment of type C nyman peak disease, 2009 approved for use in C nyman peak treatment in adult and adolescent patients of progressive neurological symptoms, then, the product have been in Australia, Canada, Switzerland, Japan and other more than 30 countries are allowed to used in the treatment of type C NPC peak disease. The product is the only drug currently approved for treatment of the disease in the world. 

 

In June 2016, the company's magnus capsule was incorporated into the domestic priority review application. In November 2016, McGonagall's capsule was listed as a "zewei", a form of a capsule with a size of 100 mg. The release of the McGonagall capsule offers the first effective treatment for the disease in the country with the disease.