(Yicai) Oct. 14 -- China has unveiled plans to promote the research and development of medicines specifically for children to fill the gap in the pharmaceutical industry.

The Center for Drug Evaluation under China’s National Medical Products Administration issued on Oct. 11 a document providing more definite support for the development of new drugs specifically for children with higher safety and efficacy standards, targeted dosage forms, and precise administration instructions.

Of the over 3,500 chemical drug preparations available in the Chinese market, only about 60 are specifically for children under 14 years old, equal to less than 2 percent of the total, according to data from the National Center for Women and Children’s Health.

Even though the approval of new pediatric medicines has accelerated, reaching 57 in the first five months of this year, there are still unmet needs, including dedicated drugs for specific children’s diseases and common drugs with suitable formulations and dosages for children.

“Modifications that do not have clinical value in adult applications, such as making tablets into oral solutions, may have clinical value or even clinical advantages in young children,” the CDE pointed out.

Developing medicines specifically for children does come with challenges, such as difficulties in recruiting patients for clinical trials, ethical dilemmas for conducting clinical trials in children, high R&D costs, and long development cycles.

For this, the CDE stressed that ensuring the safety of trial subjects is the most important aspect in pediatric drug clinical trials.

Oncology drugs have been a hotspot in pediatric drug R&D in recent years. In this regard, the CDE clarified that the rights and interests of child patients should be prioritized, and unnecessary pediatric studies should be avoided.

Moreover, in addition to their guardians’ consent, pharmaceutical companies should also obtain informed consent from the children, according to the CDE.

Editor: Futura Costaglione