The back waves of the children's medicine potential track are strong

On May 11, the official website of the Drug Evaluation Center of the State Food and Drug Administration announced that two "new varieties, dosage forms and specifications of children's drugs that meet the physiological characteristics of children" are to be included in the priority revi.

Since the establishment of the priority review channel and the inclusion of new varieties, dosage forms and specifications of children's medicines with obvious clinical value and physiological characteristics of children into the first priority level, the research and development and review and approval of children's medicines have continued to maintain a growth moment.

A few days ago, the Center for Drug Evaluation of the State Food and Drug Administration issued the "Notice on Carrying out Questionnaire Survey on Issues Related to the R&D and Application of Drugs for Children in Chin.

Solving the problem of children's drug use requires the cooperation of regulatory authorities, clinical institutions and drug manufacture.

In recent years, a number of policy measures have been introduced to encourage the development and production of children's medicin.

Ren Wuxian, Chairman of Yabao Pharmaceutical Group, said, "In recent years, relevant state departments have attached great importance to the safety and efficacy of children's medicines, and have issued a series of polici.

"The introduction of these policies has played a positive role in promoting the research and development and application of children's drugs in Chi.

It is worth noting that the dilemma of children's clinical research is a global probl.

Children's clinical trials are difficult, long-term, and risky to implement, and there is no data protection syst.

In Ren Wuxian's view, "There is no clinical guideline for changing adult drug doses to children's doses, especially when companies encounter a lot of confusion when changing adult drug doses to children's doses of different ag.

In addition, at present, there is a lack of corresponding effective incentive policies for children's medicines at the procurement and pricing leve.

Driven by national policies, the children's drug market has exploded with unprecedented vitality in recent yea.

Attracted by the market potential, more and more companies have stepped up the development of children's medicin.

However, from the perspective of the industry, children's medicines still face problems such as few varieties, inappropriate dosage forms, unreasonable specifications, poor dosage flexibility, and serious off-label drug u.

Which track areas are more promising?

Ren Wuxian pointed out, "For enterprises, it is necessary to continuously study more drug dosage forms suitable for childr.

Yang Jie believes that it can be arranged from the following three aspects:

One is the change of disease spectr.

At present, the domestic children's medicines are in the initial stage as a whole, and the medicines for common diseases in children are mainly us.

However, with the changes in the disease spectrum and the adjustment of the market structure of children's drugs, high-end drugs represented by nervous system drugs will expand the overall market capaci.

The second is rare disease and children's oncology dru.

The third is high-end preparations that meet the needs of children's clinical medicati.

In the future, sustained and controlled release preparations or special routes of administration (such as transdermal administration, transpulmonary administration, oral dissolving membranes, e.

) will become a research hotsp.

In addition, personalized medicine suitable for children at different growth and development stages will also be a hot topic in the futu.

For example: developing suitable dosage forms for children, improving taste, and improving children's medication compliance; setting scientific and reasonable specifications, developing suitable drug delivery devices, ensuring the accuracy and flexibility of children's medication doses, and improving medication safe.

For oral formulations, taste-masking techniques and mouth-feel evaluation methods deserve attenti.