On May 18, 2017, the ministry of health and family planning commission issued the "second batch of proposals for encouraging and reporting on children's medicines". In May 2016, the NHFPC has released a list of 32 medicines, the second batch of 40 drug lists.
However, even if who planning commission from the clinical demand level issued pediatric encouraged directory, when children medicine research and development policy is not clear, production enterprises may not presume to invest their resources.
The first analysis: hopefully industrialization of up to 25%?
32 products, pharmaceutical co., LTD., chengdu are green and the sichuan ding tai Chen technology co., LTD is a joint declaration of the left b raschig temple injection in the "first encourage r&d declare on the children's medicine list", and is the CDE in September 2016 as a "quasi" priority review program drug registration "list of products. Query on May 5, 2017 CDE into varieties of priority review list columns found that only the best when left than trade (Shanghai) co., LTD. B raschig injection with concentrated solution was eventually priority review. Better than left b raschig temple concentrated solution for injection and pharmaceutical co., LTD., chengdu are green left b raschig temple injection with belong to product of the first batch of inspection list, successively into the drug clinical trial data on-site verification plan announcement (7) and the drug clinical trial data on-site verification plan announcement (8), but is not the result of examination and approval, left b raschig injection no products listed in our country.
The first to encourage research and development, according to the children's drug list products such as shown in table 1, in addition to sodium bicarbonate injection in 2016 have manufacturer declare the supplement, the rest of the product after 2016 is without new registration.
Consider before filing records, the first to encourage research and development to declare the children's medicine listing products may be approved by the production of propranolol only oral solution, diazepam rectum with solution, nim horizon oral liquid and injected with recombinant human parathyroid hormone, human recombinant glucagon polypeptide injection and adrenaline hydrochloride injection, injection of sodium bicarbonate injection and left b raschig eight products, which only 25% of the product may enter the industrialization. From the side, the pediatric products are supported, but few are willing to invest.
Table 1 is one of the first to encourage the declaration of the declaration of children's medicines
编号
|
品种
|
剂型
|
规格
|
申报现状
|
1
|
苯海索
|
口服酏剂
|
0.4mg/ml
|
2016年以后没申报记录
|
2
|
苯妥英钠
|
注射剂
|
50mg/ml（5ml）
|
2016年以后没申报记录
|
3
|
地高辛
|
注射剂
|
0.05mg/ml（1ml）
|
2016年以后没申报记录
|
4
|
地西泮
|
灌肠剂
|
1mg/ml
|
2016年以后没申报记录。2005年首都儿科研究所和北京首儿药厂曾申报地西泮直肠用溶液临床并被批准临床
|
5
|
呋塞米
|
口服溶液
|
4mg/ml
|
2016年以后没申报记录。2008年曾有厂家申报该剂型临床，但未被批准
|
6
|
氟哌啶醇
|
口服溶液
|
2mg/ml
|
2016年以后没申报记录
|
7
|
卡托普利
|
口服溶液
|
5mg/ml
|
2016年只有卡托普利片的补充申请，暂无口服溶液的注册申请
|
8
|
劳拉西泮
|
注射剂
|
2mg/ml（1ml）
|
2016年以后只有劳拉西泮片的补充申请，2006年劳拉西泮注射液曾有厂家申报生产，但并未获批
|
9
|
氯硝西泮
|
口服溶液
|
0.1mg/ml
|
2016年以后没申报记录
|
10
|
咪达唑仑
|
口腔黏膜溶液
|
5mg/ml(1ml)
|
2016年以后只有咪达唑仑注射液的补充申请
|
11
|
尼莫地平
|
口服溶液
|
3mg/ml
|
2016年以后没申报记录。2014年恒瑞申报尼莫地平口服液临床，并获批临床。但暂未启动临床。
|
12
|
普萘洛尔
|
口服溶液
|
1mg/ml
|
2016年以后没申报记录。2015年已有厂家申报临床，仅武汉科福新药有限责任公司获批临床，但并未启动临床。
|
13
|
肾上腺素
|
注射剂
|
0.1mg/ml(1ml)
|
2016年以后没申报记录。2015年前有厂家补充申请盐酸肾上腺素注射液。
|
14
|
碳酸氢钠
|
注射剂
|
1.4%(100ml)
|
2016年浙江天瑞药业有限公司、成都正康药业有限公司提交补充申请，暂不知规格，2016年以前也有厂家对此剂型补充申请。
|
15
|
水合氯醛
|
口服溶液、口服混悬液或灌肠液
|
|
2016年以后没申报记录
|
16
|
二氮嗪
|
口服溶液
|
50mg/ml（30ml）
|
2016年以后没申报记录
|
17
|
长春碱（长春花碱）
|
注射剂
|
1mg
|
2016年以后没申报记录
|
18
|
苯丙氨酸氮芥（马法兰）
|
注射剂
|
50mg
|
2016年以后没申报记录
|
19
|
巯嘌呤
|
口服混悬液
|
20mg/ml
|
2016年以后没申报记录
|
20
|
华法林
|
口服混悬液
|
1mg/ml
|
2016年以后没申报记录
|
21
|
熊去氧胆酸
|
口服混悬液
|
50mg/ml
|
2016年以后没申报记录
|
22
|
左乙拉西坦
|
注射剂
|
500mg/5ml
|
2016年以后没申报记录。但之前申报生产的重庆圣华曦药业股份有限公司公告撤回外其余两家仍未有审批结果
|
23
|
异烟肼
|
糖浆剂
|
10mg/ml
|
2016年以后没申报记录
|
24
|
柳氮磺吡啶
|
口服混悬液
|
50mg/ml
|
2016年以后没申报记录
|
25
|
利福平
|
口服混悬液
|
20mg/ml
|
2016年以后只有注射用利福平申报
|
26
|
重组人甲状旁腺激素
|
注射剂
|
20ug
|
2016年以后没申报记录。2015年有该产品剂型申报记录，暂未知规格
|
27
|
胰高血糖素
|
注射剂
|
1mg
|
2016年以后没申报记录。2014年有该产品剂型申报记录，暂未知规格
|
28
|
多粘菌素E
|
口服制剂
|
|
2016年以后没申报记录
|
29
|
胰岛素样生长因子-1
|
注射剂
|
10mg
|
2016年以后没申报记录
|
30
|
双氢睾酮
|
注射剂
|
20mg
|
2016年以后没申报记录
|
31
|
双氢睾酮
|
凝胶
|
80g
|
2016年以后没申报记录
|
32
|
促皮质素（ACTH）
|
注射剂
|
40IU，80IU
|
2016年以后没申报记录
|
(source: saldar data V3.2)
The second trend: will it be the first?
The author from 40 products screening after 10 more products with market potential, found that 10 products mainly comes from diseases of the digestive system drugs, cardiovascular system disease, endocrine system disease, medication, antibiotics.
As shown in table 2, the zaphosphamide tablet has been listed as 50mg and the company only needs to add 25mg. The drug had listed the manufacturer has to amadeus Medica AG, Shanghai huashi pharmaceutical pharmaceutical factory, gongzhuling city red scales pharmaceutical factory, nantong essence pharmaceutical, jilin fai south long tightsen pharmaceutical biochemistry pharmaceutical co., shanxi, guangzhou baiyun mountain sunrise rich auspicious pharmaceutical, guanghua school of pharmacy, liaoning Dan MAO auspicious pharmaceutical pharmaceutical and tonghua, green above manufacturer didn't register this product, eventually lead to the product formulations are exclusive.
The acetaminopressin spray was approved in 2005 but has not been reported.
To sum up, the above products in the past registered declare, even the popular chemical medicine, but the dosage form is more wide, reporting on the number of manufacturers is not much. In the current state of reporting, the second batch of incentives for the development of the recommended children's drug recommendations is still likely to be cold.
The second batch of table 2 encourages the development of the list of recommended children's medicines and recommends the most promising status of the declaration
品种
|
剂型
|
规格
|
申报现状
|
奥美拉唑
|
口服溶液剂
|
2mg/ml
|
暂无申报
|
埃索美拉唑
|
颗粒剂
|
10mg
|
暂无颗粒剂申报。江苏豪森药业申报埃索美拉唑镁肠溶口服干混悬剂
|
氨氯地平
|
口服混悬剂
|
1mg/ml
|
暂无申报
|
骨化三醇
|
口服溶液剂
|
1μg/ml
|
暂无申报
|
盐酸二甲双胍
|
口服溶液剂
|
100mg/ml
|
2009年曾有厂家申报此剂型，全部不予批准。
|
万古霉素
|
口服液体制剂
|
125mg
|
暂无申报
|
艾司洛尔
|
片剂
|
50mg
|
暂无申报
|
环磷酰胺
|
片剂
|
25mg
|
通化茂祥制药已上市50mg
|
去氨加压素
|
口服溶液剂
|
360ug/ml
|
暂无申报
|
去氨加压素
|
鼻用喷雾剂
|
10μg/揿
|
醋酸去氨加压素喷雾剂2005年曾获批临床
|
(source: saldar data V3.2)
Children's drugs are low: clinical trial guidelines have been delayed
Since 2015, the CFDA reform has been accompanied by strong support for the development of children's drug use. The administration from 2017 about asking "about encourage pharmaceutical medical equipment innovation policies of protection of innovators (draft)" opinion also can see the announcement: innovation of approved drugs, for 6 years data protection; It is an innovative medicine which belongs to the rare medical treatment and the children's special medicine, and gives a 10-year data protection period. It is a rare medical treatment for new drugs, children's special medicine, and three-year data protection period. "The general administration's opinion on the review and approval of the review and approval of the review and approval of the registration of drug registrations" includes children's use of drugs.
Drug purchase, "the state council general office on perfecting public hospital drug centralized procurement guidelines" fu specialist generics are not included in the bid procurement of medicines, and to direct the net purchase drugs, this is a country from the aspects of drug prices and drug supply accessibility for child support.
The key to the delay in the development of medicines for children, however, is that clinical trials are harder to implement. 2015 for pediatric population drug clinical trials "technical guidelines", in 2016 for "adult medication data extrapolation in the pediatric population of drug clinical trials and the relevant information of technical guidelines", in 2017 for "pediatric drug non-clinical safety studies technical guidelines", nearly three years of technical guidelines are not officially announced.
"Technical guidelines" pediatric population drug clinical trials in the draft, parents/legal guardians of informed consent required of informed consent, and pediatric patients informed consent, this means that unless the children patients is a rare disease or severe need to drug treatment, the general disease more difficult to obtain the informed consent of parents/legal guardians.
"Adult medication data extrapolation in the pediatric population of drug clinical trials and the relevant information of technical guidelines" is still in for advice, what kind of conditions can be free of clinical medicine for children guidelines did not, therefore, medicine production enterprises for children is more of a wait-and-see rather than investment.
Small knot
When research and development policies are not clear, even if the NHFPC has introduced a catalogue of pediatric incentives from the clinical requirements level, it is unlikely that manufacturers will venture into resources. Market expectations and development difficulty is the focus of production enterprises, in 2017 the second batch of advocated by catalog part have more potential than the first, if the 2017 children's drugs research and development related policies more clear, is expected there will be more companies willing to set up the second batch.
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